Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

October 19, 2018 updated by: Sanofi

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.

Secondary Objectives:

  • To evaluate the safety and tolerability of dupilumab.
  • To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
  • To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.

Study Type

Interventional

Enrollment (Actual)

1902

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, B8000JRB
        • Investigational Site Number 032006
      • Buenos Aires, Argentina, C1121ABE
        • Investigational Site Number 032002
      • Caba, Argentina, 1120
        • Investigational Site Number 032011
      • Caba, Argentina, C1425BEN
        • Investigational Site Number 032001
      • Caba, Argentina, C1414AIF
        • Investigational Site Number 032007
      • Caba, Argentina, C1425FVH
        • Investigational Site Number 032003
      • Caba, Argentina, C1426ABP
        • Investigational Site Number 032010
      • Capital Federal, Argentina, C1425DUC
        • Investigational Site Number 032005
      • La Plata, Argentina, B1900DXM
        • Investigational Site Number 032008
      • Rosario, Argentina, S2000JKR
        • Investigational Site Number 032004
      • San Miguel De Tucuman, Argentina, T4000CHE
        • Investigational Site Number 032012
      • San Miguel De Tucumán, Argentina, T4000IAR
        • Investigational Site Number 032009
  • Australia
      • Campbelltown, Australia, 2560
        • Investigational Site Number 036005
      • Clayton, Australia, 3168
        • Investigational Site Number 036001
      • Frankston, Australia, 3199
        • Investigational Site Number 036002
      • Glen Osmond, Australia, 5064
        • Investigational Site Number 036006
      • Murdoch, Australia, 6150
        • Investigational Site Number 036003
      • Parkville, Australia, 3050
        • Investigational Site Number 036004
  • Brazil
      • Florianópolis, Brazil, 88040-970
        • Investigational Site Number 076009
      • Porto Alegre, Brazil, 90610-000
        • Investigational Site Number 076001
      • Porto Alegre, Brazil, 90020-090
        • Investigational Site Number 076007
      • Salvador, Brazil, 41940-455
        • Investigational Site Number 076003
      • Sao Paulo, Brazil, 04266-010
        • Investigational Site Number 076012
      • Sao Paulo, Brazil, 05403-000
        • Investigational Site Number 076008
      • Sao Paulo, Brazil, 05437-010
        • Investigational Site Number 076006
      • Sorocaba, Brazil, 18040-425
        • Investigational Site Number 076002
      • São Bernardo Do Campo, Brazil, 09715-090
        • Investigational Site Number 076013
  • Canada
      • Burlington, Canada, L7N 3V2
        • Investigational Site Number 124019
      • Calgary, Canada, T2N 4Z6
        • Investigational Site Number 124009
      • Mississauga, Canada, L5A 3V4
        • Investigational Site Number 124003
      • Montreal, Canada, H2W 1T8
        • Investigational Site Number 124001
      • Montreal, Canada, H4A 3J1
        • Investigational Site Number 124012
      • Montreal, Canada, H4J 1C5
        • Investigational Site Number 124010
      • Ottawa, Canada, K1G 6C6
        • Investigational Site Number 124013
      • Quebec, Canada, G1V 4G5
        • Investigational Site Number 124018
      • Quebec, Canada, G1V 4W2
        • Investigational Site Number 124014
      • Sherbrooke, Canada, J1H 5N4
        • Investigational Site Number 124008
      • Toronto, Canada, M5G 1E2
        • Investigational Site Number 124015
      • Toronto, Canada, M5T 3A9
        • Investigational Site Number 124002
      • Trois-Rivieres, Canada, G8T 7A1
        • Investigational Site Number 124007
      • Vancouver, Canada, V5Z 1M9
        • Investigational Site Number 124006
  • Chile
      • Concepción, Chile, 41
        • Investigational Site Number 152015
      • Quillota, Chile, 2260877
        • Investigational Site Number 152003
      • Santiago, Chile, 7500588
        • Investigational Site Number 152014
      • Santiago, Chile, 7500692
        • Investigational Site Number 152001
      • Santiago, Chile, 7500698
        • Investigational Site Number 152002
      • Santiago, Chile, 7500710
        • Investigational Site Number 152008
      • Santiago, Chile, 7560994
        • Investigational Site Number 152017
      • Santiago, Chile, 8207257
        • Investigational Site Number 152007
      • Santiago, Chile, 8380456
        • Investigational Site Number 152005
      • Santiago, Chile, 8910131
        • Investigational Site Number 152009
      • Talca, Chile, 3460001
        • Investigational Site Number 152004
      • Talcahuano, Chile, 427918
        • Investigational Site Number 152013
      • Temuco, Chile, 4781156
        • Investigational Site Number 152016
      • Valdivia, Chile
        • Investigational Site Number 152010
      • Viña Del Mar, Chile, 2520594
        • Investigational Site Number 152011
      • Viña Del Mar, Chile
        • Investigational Site Number 152012
  • Colombia
      • Bogota, Colombia, 110221
        • Investigational Site Number 170001
      • Bogota, Colombia, 110131
        • Investigational Site Number 170006
      • Bogotá, Colombia, 110231
        • Investigational Site Number 170002
      • Bogotá, Colombia, 111321
        • Investigational Site Number 170003
  • France
      • Brest, France, 29609
        • Investigational Site Number 250002
      • Lille, France, 59000
        • Investigational Site Number 250013
      • Lille Cedex, France, 59037
        • Investigational Site Number 250011
      • Lyon, France, 69317
        • Investigational Site Number 250004
      • Marseille, France, 13015
        • Investigational Site Number 250010
      • Montpellier, France, 34295
        • Investigational Site Number 250005
      • Nantes Cedex 1, France, 44093
        • Investigational Site Number 250003
      • Paris, France, 75012
        • Investigational Site Number 250012
      • Paris, France, 75018
        • Investigational Site Number 250001
      • Strasbourg, France, 67091
        • Investigational Site Number 250008
      • Vandoeuvre-Les-Nancy, France, 54511
        • Investigational Site Number 250014
  • Germany
      • Berlin, Germany, 10787
        • Investigational Site Number 276006
      • Bochum, Germany, 44789
        • Investigational Site Number 276003
      • Frankfurt Am Main, Germany, 60596
        • Investigational Site Number 276010
      • Hannover, Germany, 30625
        • Investigational Site Number 276004
      • Koblenz, Germany, 56068
        • Investigational Site Number 276009
      • Lübeck, Germany, 23538
        • Investigational Site Number 276007
      • Mainz, Germany, 55131
        • Investigational Site Number 276001
      • Rüdersdorf, Germany, 15562
        • Investigational Site Number 276005
  • Hungary
      • Gödöllö, Hungary, 2100
        • Investigational Site Number 348003
  • Italy
      • Ancona, Italy, 60126
        • Investigational Site Number 380004
      • Catania, Italy, 95123
        • Investigational Site Number 380005
      • Ferrara, Italy, 44124
        • Investigational Site Number 380003
      • Firenze, Italy, 50134
        • Investigational Site Number 380006
      • Foggia, Italy, 71122
        • Investigational Site Number 380010
      • Modena, Italy, 41124
        • Investigational Site Number 380002
      • Palermo, Italy, 90146
        • Investigational Site Number 380009
      • Pisa, Italy, 56124
        • Investigational Site Number 380001
      • Reggio Emilia, Italy, 42123
        • Investigational Site Number 380014
      • Torino, Italy, 10128
        • Investigational Site Number 380011
  • Japan
      • Akashi-Shi, Japan
        • Investigational Site Number 392185
      • Asahikawa-Shi, Japan
        • Investigational Site Number 392128
      • Chiyoda-Ku, Japan
        • Investigational Site Number 392118
      • Chuo-Ku, Japan
        • Investigational Site Number 392112
      • Fukui-Shi, Japan
        • Investigational Site Number 392157
      • Fukuoka-Shi, Japan
        • Investigational Site Number 392137
      • Fukuyama-Shi, Japan
        • Investigational Site Number 392117
      • Habikino-Shi, Japan
        • Investigational Site Number 392121
      • Higashiosaka-Shi, Japan
        • Investigational Site Number 392154
      • Himeji-Shi, Japan
        • Investigational Site Number 392109
      • Hiroshima-Shi, Japan
        • Investigational Site Number 392108
      • Hiroshima-Shi, Japan
        • Investigational Site Number 392158
      • Iizuka-Shi, Japan
        • Investigational Site Number 392107
      • Isesaki-Shi, Japan
        • Investigational Site Number 392101
      • Itabashi-Ku, Japan
        • Investigational Site Number 392147
      • Kagoshima-Shi, Japan
        • Investigational Site Number 392150
      • Kagoshima-Shi, Japan
        • Investigational Site Number 392178
      • Kanazawa-Shi, Japan
        • Investigational Site Number 392110
      • Kanazawa-Shi, Japan
        • Investigational Site Number 392136
      • Kasuga-Shi, Japan
        • Investigational Site Number 392142
      • Kawaguchi-Shi, Japan
        • Investigational Site Number 392166
      • Kishiwada-Shi, Japan
        • Investigational Site Number 392119
      • Kobe-Shi, Japan
        • Investigational Site Number 392162
      • Kodaira-Shi, Japan
        • Investigational Site Number 392182
      • Kokubunji-Shi, Japan
        • Investigational Site Number 392174
      • Koshi-Shi, Japan
        • Investigational Site Number 392131
      • Koshigaya-Shi, Japan
        • Investigational Site Number 392183
      • Kurashiki-Shi, Japan
        • Investigational Site Number 392129
      • Kyoto-Shi, Japan
        • Investigational Site Number 392153
      • Kyoto-Shi, Japan
        • Investigational Site Number 392176
      • Kyoto-Shi, Japan
        • Investigational Site Number 392184
      • Machida-Shi, Japan
        • Investigational Site Number 392133
      • Matsuyama-Shi, Japan
        • Investigational Site Number 392135
      • Mibu, Japan
        • Investigational Site Number 392172
      • Minato-Ku, Japan
        • Investigational Site Number 392122
      • Minato-Ku, Japan
        • Investigational Site Number 392144
      • Minato-Ku, Japan
        • Investigational Site Number 392114
      • Mizunami-Shi, Japan
        • Investigational Site Number 392106
      • Muroran-Shi, Japan
        • Investigational Site Number 392164
      • Nagakute-Shi, Japan
        • Investigational Site Number 392161
      • Nagoya-Shi, Japan
        • Investigational Site Number 392163
      • Naka-Gun, Japan
        • Investigational Site Number 392102
      • Nakano-Ku, Japan
        • Investigational Site Number 392125
      • Naruto-Shi, Japan
        • Investigational Site Number 392115
      • Obihiro-Shi, Japan
        • Investigational Site Number 392187
      • Ome-Shi, Japan
        • Investigational Site Number 392177
      • Osaka Sayama-Shi, Japan
        • Investigational Site Number 392152
      • Osaka Sayama-Shi, Japan
        • Investigational Site Number 392155
      • Osaki-Shi, Japan
        • Investigational Site Number 392170
      • Ota-Ku, Japan
        • Investigational Site Number 392127
      • Ota-Ku, Japan
        • Investigational Site Number 392120
      • Ota-Shi, Japan
        • Investigational Site Number 392138
      • Oura-Gun, Japan
        • Investigational Site Number 392123
      • Sagamihara-Shi, Japan
        • Investigational Site Number 392169
      • Sapporo-Shi, Japan
        • Investigational Site Number 392149
      • Seto-Shi, Japan
        • Investigational Site Number 392179
      • Shibuya-Ku, Japan
        • Investigational Site Number 392186
      • Shinagawa-Ku, Japan
        • Investigational Site Number 392167
      • Shinagawa-Ku, Japan
        • Investigational Site Number 392139
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392130
      • Sumida-Ku, Japan
        • Investigational Site Number 392165
      • Tachikawa-Shi, Japan
        • Investigational Site Number 392146
      • Tachikawa-Shi, Japan
        • Investigational Site Number 392173
      • Tokyo, Japan
        • Investigational Site Number 392103
      • Tomakomai-Shi, Japan
        • Investigational Site Number 392113
      • Tsu-Shi, Japan
        • Investigational Site Number 392151
      • Uozu-Shi, Japan
        • Investigational Site Number 392168
      • Urasoe-Shi, Japan
        • Investigational Site Number 392132
      • Uruma-Shi, Japan
        • Investigational Site Number 392134
      • Wakayama-Shi, Japan
        • Investigational Site Number 392116
      • Yokohama-Shi, Japan
        • Investigational Site Number 392140
      • Yonago-Shi, Japan
        • Investigational Site Number 392159
  • Korea, Republic of
      • Bucheon-Si, Korea, Republic of, 14584
        • Investigational Site Number 410002
      • Busan, Korea, Republic of, 49201
        • Investigational Site Number 410015
      • Cheongju-Si, Korea, Republic of, 28644
        • Investigational Site Number 410003
      • Incheon, Korea, Republic of, 21565
        • Investigational Site Number 410013
      • Seoul, Korea, Republic of, 04763
        • Investigational Site Number 410012
      • Seoul, Korea, Republic of, 03080
        • Investigational Site Number 410006
      • Seoul, Korea, Republic of, 03722
        • Investigational Site Number 410004
      • Seoul, Korea, Republic of, 05505
        • Investigational Site Number 410005
      • Seoul, Korea, Republic of, 06351
        • Investigational Site Number 410007
      • Seoul, Korea, Republic of, 06973
        • Investigational Site Number 410010
      • Seoul, Korea, Republic of, 08308
        • Investigational Site Number 410011
      • Seoul, Korea, Republic of, 02559
        • Investigational Site Number 410008
      • Seoul, Korea, Republic of, 06591
        • Investigational Site Number 410009
      • Suwon, Korea, Republic of, 16499
        • Investigational Site Number 410001
      • Uijeongbu-Si, Korea, Republic of, 11765
        • Investigational Site Number 410014
  • Mexico
      • Chihuahua, Mexico, 31020
        • Investigational Site Number 484013
      • Chihuahua, Mexico, 31200
        • Investigational Site Number 484006
      • Cuautitlan Izcalli, Mexico, 54769
        • Investigational Site Number 484014
      • Durango, Mexico, 34080
        • Investigational Site Number 484008
      • Guadalajara, Mexico, 44100
        • Investigational Site Number 484001
      • Mexico City, Mexico, 64718
        • Investigational Site Number 484004
      • Monterrey, Mexico, 64460
        • Investigational Site Number 484003
      • Monterrey, Mexico, 66465
        • Investigational Site Number 484007
      • México, Mexico, 06700
        • Investigational Site Number 484010
      • San Juan Del Rio, Mexico, 76800
        • Investigational Site Number 484012
      • Veracruz, Mexico, 91910
        • Investigational Site Number 484011
      • Zapopan, Mexico, 45100
        • Investigational Site Number 484015
  • Poland
      • Bialystok, Poland, 15-010
        • Investigational Site Number 616006
      • Gdansk, Poland, 80-952
        • Investigational Site Number 616003
      • Krakow, Poland, 31-159
        • Investigational Site Number 616007
      • Lodz, Poland, 90-141
        • Investigational Site Number 616001
      • Lodz, Poland, 90-153
        • Investigational Site Number 616005
      • Lodz, Poland, 90-329
        • Investigational Site Number 616009
      • Poznan, Poland, 60-693
        • Investigational Site Number 616002
      • Sopot, Poland, 81-741
        • Investigational Site Number 616004
      • Strzelce Opolskie, Poland, 47-100
        • Investigational Site Number 616008
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620109
        • Investigational Site Number 643013
      • Moscow, Russian Federation, 115280
        • Investigational Site Number 643005
      • Moscow, Russian Federation, 125315
        • Investigational Site Number 643001
      • Moscow, Russian Federation, 105077
        • Investigational Site Number 643006
      • Moscow, Russian Federation, 109240
        • Investigational Site Number 643003
      • Moscow, Russian Federation, 117574
        • Investigational Site Number 643002
      • Moscow, Russian Federation, 123182
        • Investigational Site Number 643004
      • Ryazan, Russian Federation, 390039
        • Investigational Site Number 643011
      • Saint-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643008
      • Saint-Petersburg, Russian Federation, 195030
        • Investigational Site Number 643009
      • St-Petersburg, Russian Federation, 193231
        • Investigational Site Number 643007
      • St-Petersburg, Russian Federation, 197022
        • Investigational Site Number 643010
      • Yaroslavl, Russian Federation, 150003
        • Investigational Site Number 643012
  • South Africa
      • Brandfort, South Africa, 9400
        • Investigational Site Number 710009
      • Cape Town, South Africa, 7505
        • Investigational Site Number 710011
      • Cape Town, South Africa, 8000
        • Investigational Site Number 710003
      • Cape Town, South Africa, 7700
        • Investigational Site Number 710001
      • Cape Town, South Africa, 7764
        • Investigational Site Number 710010
      • Cape Town, South Africa, 7530
        • Investigational Site Number 710004
      • Cape Town, South Africa, 7700
        • Investigational Site Number 710002
      • Durban, South Africa, 4071
        • Investigational Site Number 710006
      • Durban, South Africa, 4001
        • Investigational Site Number 710005
      • Pretoria, South Africa, 0087
        • Investigational Site Number 710007
  • Spain
      • Barcelona, Spain, 08036
        • Investigational Site Number 724001
      • Barcelona, Spain, 08035
        • Investigational Site Number 724002
      • Palma De Mallorca, Spain, 07120
        • Investigational Site Number 724010
      • Pozuelo De Alarcón, Spain, 28223
        • Investigational Site Number 724005
      • Sant Boi De Llobregat, Spain, 08830
        • Investigational Site Number 724004
      • Santiago De Compostela, Spain, 15706
        • Investigational Site Number 724006
      • Sevilla, Spain, 41071
        • Investigational Site Number 724008
      • Valencia, Spain, 46017
        • Investigational Site Number 724007
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Investigational Site Number 158004
      • Kaohsiung, Taiwan, 82445
        • Investigational Site Number 158002
      • New Taipei City, Taiwan, 23561
        • Investigational Site Number 158008
      • Taichung, Taiwan, 40447
        • Investigational Site Number 158007
      • Taichung, Taiwan, 40201
        • Investigational Site Number 158005
      • Taipei, Taiwan, 10043
        • Investigational Site Number 158001
      • Taipei, Taiwan, 11031
        • Investigational Site Number 158009
      • Taoyuan, Taiwan, 333
        • Investigational Site Number 158006
  • Turkey
      • Ankara, Turkey, 06100
        • Investigational Site Number 792004
      • Ankara, Turkey, 06100
        • Investigational Site Number 792008
      • Bursa, Turkey, 16059
        • Investigational Site Number 792003
      • Istanbul, Turkey, 34098
        • Investigational Site Number 792001
      • Istanbul, Turkey, 34668
        • Investigational Site Number 792007
      • Izmir, Turkey, 35040
        • Investigational Site Number 792005
      • Izmir, Turkey, 35110
        • Investigational Site Number 792010
      • Kirikkale, Turkey, 71450
        • Investigational Site Number 792009
      • Kocaeli, Turkey, 41100
        • Investigational Site Number 792011
      • Mersin, Turkey, 33070
        • Investigational Site Number 792002
      • Rize, Turkey, 53100
        • Investigational Site Number 792006
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Investigational Site Number 804007
      • Dnipro, Ukraine, 49101
        • Investigational Site Number 804023
      • Ivano-Frankivsk, Ukraine, 76018
        • Investigational Site Number 804009
      • Ivano-Frankivsk, Ukraine, 76018
        • Investigational Site Number 804004
      • Kharkiv, Ukraine, 61058
        • Investigational Site Number 804005
      • Kharkiv, Ukraine, 61093
        • Investigational Site Number 804021
      • Kharkiv, Ukraine, 61124
        • Investigational Site Number 804001
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804003
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804008
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804017
      • Kyiv, Ukraine, 04050
        • Investigational Site Number 804016
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804011
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804013
      • Odessa, Ukraine, 65025
        • Investigational Site Number 804006
      • Poltava, Ukraine, 36038
        • Investigational Site Number 804002
      • Ternopil, Ukraine, 46000
        • Investigational Site Number 804014
      • Vinnytsya, Ukraine, 21001
        • Investigational Site Number 804012
      • Zaporizhia, Ukraine, 69076
        • Investigational Site Number 804022
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Investigational Site Number 826001
      • London, United Kingdom, EC1M 6BQ
        • Investigational Site Number 826002
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Investigational Site Number 826005
      • Portsmouth, United Kingdom, PO6 3LY
        • Investigational Site Number 826007
      • South Shields, United Kingdom, NE34 0PL
        • Investigational Site Number 826006
      • Sutton-In-Ashfield, United Kingdom, NG17 4JL
        • Investigational Site Number 826003
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Investigational Site Number 840047
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Investigational Site Number 840056
      • Gilbert, Arizona, United States, 85234
        • Investigational Site Number 840099
      • Scottsdale, Arizona, United States, 85251
        • Investigational Site Number 840087
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Investigational Site Number 840132
    • California
      • Bakersfield, California, United States, 93301
        • Investigational Site Number 840109
      • Costa Mesa, California, United States, 92626
        • Investigational Site Number 840052
      • Fresno, California, United States, 93720
        • Investigational Site Number 840116
      • Long Beach, California, United States, 90720
        • Investigational Site Number 840045
      • Los Angeles, California, United States, 90025
        • Investigational Site Number 840011
      • Los Angeles, California, United States, 90048
        • Investigational Site Number 840061
      • Los Angeles, California, United States, 90064
        • Investigational Site Number 840097
      • Mission Viejo, California, United States, 92691
        • Investigational Site Number 840019
      • Newport Beach, California, United States, 92663
        • Investigational Site Number 840125
      • North Hollywood, California, United States, 91606
        • Investigational Site Number 840041
      • Redwood City, California, United States, 94063
        • Investigational Site Number 840036
      • Rolling Hills Estates, California, United States, 90274
        • Investigational Site Number 840020
      • Roseville, California, United States, 95661
        • Investigational Site Number 840074
      • San Jose, California, United States, 95117
        • Investigational Site Number 840021
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Investigational Site Number 840004
      • Colorado Springs, Colorado, United States, 80907
        • Investigational Site Number 840025
      • Denver, Colorado, United States, 80246
        • Investigational Site Number 840130
      • Denver, Colorado, United States, 80230
        • Investigational Site Number 840034
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Investigational Site Number 840102
    • Florida
      • Aventura, Florida, United States, 33180
        • Investigational Site Number 840037
      • Boynton Beach, Florida, United States, 33472
        • Investigational Site Number 840018
      • Brandon, Florida, United States, 33511
        • Investigational Site Number 840105
      • Clearwater, Florida, United States, 33765
        • Investigational Site Number 840092
      • Hialeah, Florida, United States, 33012
        • Investigational Site Number 840122
      • Loxahatchee Groves, Florida, United States, 33470
        • Investigational Site Number 840053
      • Miami, Florida, United States, 33173
        • Investigational Site Number 840069
      • Ocala, Florida, United States, 34471
        • Investigational Site Number 840123
      • Ocala, Florida, United States, 34474
        • Investigational Site Number 840071
      • Ocoee, Florida, United States, 34761
        • Investigational Site Number 840115
      • Sarasota, Florida, United States, 34239
        • Investigational Site Number 840055
      • South Miami, Florida, United States, 33143
        • Investigational Site Number 840114
      • Tampa, Florida, United States, 33612
        • Investigational Site Number 840048
    • Georgia
      • Gainesville, Georgia, United States, 30506
        • Investigational Site Number 840084
      • Savannah, Georgia, United States, 31406
        • Investigational Site Number 840044
    • Idaho
      • Twin Falls, Idaho, United States, 83301
        • Investigational Site Number 840079
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigational Site Number 840101
      • River Forest, Illinois, United States, 60305
        • Investigational Site Number 840015
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Investigational Site Number 840089
    • Kentucky
      • Fort Mitchell, Kentucky, United States, 41017
        • Investigational Site Number 840032
      • Owensboro, Kentucky, United States, 42303
        • Investigational Site Number 840009
    • Maine
      • Bangor, Maine, United States, 04401
        • Investigational Site Number 840064
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Investigational Site Number 840080
      • Chevy Chase, Maryland, United States, 20815
        • Investigational Site Number 840017
      • Gaithersburg, Maryland, United States, 20878
        • Investigational Site Number 840073
      • White Marsh, Maryland, United States, 21162
        • Investigational Site Number 840127
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Investigational Site Number 840014
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Investigational Site Number 840005
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Investigational Site Number 840013
      • Saint Louis, Missouri, United States, 63141
        • Investigational Site Number 840002
      • Saint Louis, Missouri, United States, 63141
        • Investigational Site Number 840093
    • Montana
      • Missoula, Montana, United States, 59808
        • Investigational Site Number 840026
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Investigational Site Number 840078
      • Papillion, Nebraska, United States, 27103
        • Investigational Site Number 840003
    • New Jersey
      • Brick, New Jersey, United States, 08723
        • Investigational Site Number 840111
      • Ocean City, New Jersey, United States, 07712
        • Investigational Site Number 840068
      • Princeton, New Jersey, United States, 08540
        • Investigational Site Number 840016
      • Toms River, New Jersey, United States, 08775
        • Investigational Site Number 840096
    • New York
      • Bronx, New York, United States, 10457
        • Investigational Site Number 840031
      • Jamaica, New York, United States, 11435
        • Investigational Site Number 840106
      • New York, New York, United States, 10029
        • Investigational Site Number 840065
      • Rochester, New York, United States, 14642
        • Investigational Site Number 840076
    • North Carolina
      • Charlotte, North Carolina, United States, 28226
        • Investigational Site Number 840126
      • Charlotte, North Carolina, United States, 28277
        • Investigational Site Number 840083
      • Durham, North Carolina, United States, 27705
        • Investigational Site Number 840108
      • Greensboro, North Carolina, United States, 27403
        • Investigational Site Number 840107
      • High Point, North Carolina, United States, 27262
        • Investigational Site Number 840007
    • Ohio
      • Cincinnati, Ohio, United States, 45241
        • Investigational Site Number 840046
      • Middleburg Heights, Ohio, United States, 44130
        • Investigational Site Number 840049
      • Toledo, Ohio, United States, 43617
        • Investigational Site Number 840042
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Investigational Site Number 840112
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Site Number 840121
      • Tulsa, Oklahoma, United States, 74136
        • Investigational Site Number 840104
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Investigational Site Number 840040
      • Medford, Oregon, United States, 97504
        • Investigational Site Number 840039
      • Portland, Oregon, United States, 97223
        • Investigational Site Number 840001
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Investigational Site Number 840085
      • Philadelphia, Pennsylvania, United States, 19140
        • Investigational Site Number 840067
      • Philadelphia, Pennsylvania, United States, 19102
        • Investigational Site Number 840081
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigational Site Number 840010
      • Pittsburgh, Pennsylvania, United States, 15213
        • Investigational Site Number 840028
      • Pittsburgh, Pennsylvania, United States, 15241
        • Investigational Site Number 840091
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02286
        • Investigational Site Number 840029
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Investigational Site Number 840082
      • Greenville, South Carolina, United States, 29607
        • Investigational Site Number 840117
      • Greer, South Carolina, United States, 29651
        • Investigational Site Number 840100
      • Spartanburg, South Carolina, United States, 29303
        • Investigational Site Number 840054
    • Texas
      • Amarillo, Texas, United States, 79106
        • Investigational Site Number 840062
      • Austin, Texas, United States, 78759
        • Investigational Site Number 840098
      • Boerne, Texas, United States, 78006
        • Investigational Site Number 840038
      • Cypress, Texas, United States, 77429
        • Investigational Site Number 840124
      • Dallas, Texas, United States, 75231
        • Investigational Site Number 840008
      • Dallas, Texas, United States, 75246
        • Investigational Site Number 840094
      • El Paso, Texas, United States, 79903
        • Investigational Site Number 840023
      • Fort Worth, Texas, United States, 76244
        • Investigational Site Number 840027
      • Fort Worth, Texas, United States, 76109
        • Investigational Site Number 840022
      • Killeen, Texas, United States, 76542
        • Investigational Site Number 840066
      • Live Oak, Texas, United States, 78233
        • Investigational Site Number 840050
      • McKinney, Texas, United States, 75069
        • Investigational Site Number 840070
      • McKinney, Texas, United States, 75071
        • Investigational Site Number 840128
      • Plano, Texas, United States, 75093
        • Investigational Site Number 840118
      • San Antonio, Texas, United States, 78229
        • Investigational Site Number 840012
      • San Antonio, Texas, United States, 78251
        • Investigational Site Number 840129
      • Sealy, Texas, United States, 77474
        • Investigational Site Number 840133
      • Spring, Texas, United States, 77380
        • Investigational Site Number 840119
    • Utah
      • Draper, Utah, United States, 84020
        • Investigational Site Number 840035
      • Murray, Utah, United States, 84107
        • Investigational Site Number 840077
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Investigational Site Number 840057
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Investigational Site Number 840059
      • Richmond, Virginia, United States, 23294
        • Investigational Site Number 840113
    • Washington
      • Bellevue, Washington, United States, 98225
        • Investigational Site Number 840051
      • Spokane, Washington, United States, 99202
        • Investigational Site Number 840043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:

a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.

i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).

ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1.

Exclusion criteria:

  • Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age).
  • Weight is less than 30 kilograms.
  • Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
  • A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
  • Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
  • Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis.
  • Current smoker or cessation of smoking within 6 months prior to Visit 1.
  • Previous smoker with a smoking history >10 pack-years.
  • Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (for Dupilumab 200 mg) q2w
2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Drug: Placebo
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Drug: Inhaled corticosteroid (ICS) therapy
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Drug: Albuterol/Salbutamol
Oral inhalation as needed
Drug: Levalbuterol/Levosalbutamol
Oral inhalation as needed
Experimental: Dupilumab 200 mg q2w
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Drug: Dupilumab
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Other Names:
  • REGN668
  • SAR231893
Drug: Inhaled corticosteroid (ICS) therapy
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Drug: Albuterol/Salbutamol
Oral inhalation as needed
Drug: Levalbuterol/Levosalbutamol
Oral inhalation as needed
Placebo Comparator: Placebo (for Dupilumab 300 mg) q2w
2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Drug: Placebo
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Drug: Inhaled corticosteroid (ICS) therapy
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Drug: Albuterol/Salbutamol
Oral inhalation as needed
Drug: Levalbuterol/Levosalbutamol
Oral inhalation as needed
Experimental: Dupilumab 300 mg q2w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Drug: Dupilumab
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Other Names:
  • REGN668
  • SAR231893
Drug: Inhaled corticosteroid (ICS) therapy
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Drug: Albuterol/Salbutamol
Oral inhalation as needed
Drug: Levalbuterol/Levosalbutamol
Oral inhalation as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population
Time Frame: Baseline to Week 52
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 52
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Time Frame: Baseline to Week 52
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 52
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Time Frame: Baseline to Week 52
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 52
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L
Time Frame: Baseline to Week 52
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 52
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline
Time Frame: Baseline to Week 52
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 52
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population
Time Frame: Baseline, Week 24
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Baseline, Week 24
Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Time Frame: Baseline, Week 24
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Baseline, Week 24
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population
Time Frame: Baseline, Week 24
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Baseline, Week 24
Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population
Time Frame: Baseline to Week 52
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 52
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 24, 36, and 52
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Weeks 2, 4, 8, 24, 36, and 52
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 24, 36, and 52
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Weeks 2, 4, 8, 24, 36, and 52
Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population
Time Frame: Baseline to Week 52
LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 52
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
Time Frame: Baseline up to Week 52
The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1. For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier. The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics.
Baseline up to Week 52
Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
Time Frame: Baseline up to Week 52
The time to first LOAC event was defined as follows: date of the first event - first dose date +1. For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier.
Baseline up to Week 52
Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 36, and 52
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Baseline, Weeks 2, 4, 8, 12, 36, and 52
Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted). Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). Clinic staff scored the FEV1% predicted on a 7-point scale. The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter. In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs.
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 12, 36, and 52
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Baseline, Weeks 12, 36, and 52
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 12, 24, 36, and 52
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).
Baseline, Weeks 12, 24, 36, and 52
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population
Time Frame: Baseline, Weeks 12, 24, 36, and 52
The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.
Baseline, Weeks 12, 24, 36, and 52
Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis
Time Frame: Baseline, Weeks 12, 24, 36, and 52
The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Baseline, Weeks 12, 24, 36, and 52
Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis
Time Frame: Baseline, Weeks 12, 24, 36, and 52
RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better).
Baseline, Weeks 12, 24, 36, and 52

Collaborators and Investigators

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Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 27, 2015

Primary Completion (Actual)

July 29, 2017

Study Completion (Actual)

November 23, 2017

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 13, 2015

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

June 1, 2018

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Other Study ID Numbers

  • EFC13579
  • 2014-004940-36 (EudraCT Number)
  • U1111-1163-1293 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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