Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

March 21, 2022 updated by: Sanofi

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

Primary Objective:

To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).

Secondary Objectives:

To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.

To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

Systemic exposure
Anti-drug antibodies
Biomarkers

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Drug: Dupilumab

Detailed Description

A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval.

Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.

Study Type

Interventional

Enrollment (Actual)

2282

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 032096
  - Buenos Aires, Argentina, B6500BWQ
    - Investigational Site Number 032004
  - Buenos Aires, Argentina, C1121ABE
    - Investigational Site Number 032003
  - Caba, Argentina, 1120
    - Investigational Site Number 032011
  - Caba, Argentina, C1414AIF
    - Investigational Site Number 032097
  - Caba, Argentina, C1425BEN
    - Investigational Site Number 032001
  - Caba, Argentina, C1425FVH
    - Investigational Site Number 032010
  - Caba, Argentina, C1426ABP
    - Investigational Site Number 032091
  - Capital Federal, Argentina, C1425DUC
    - Investigational Site Number 032095
  - La Plata, Argentina, B1900BNN
    - Investigational Site Number 032002
  - Rosario, Argentina, S2000BRH
    - Investigational Site Number 032006
  - Rosario, Argentina, S2000DBS
    - Investigational Site Number 032007
  - Rosario, Argentina, S2000JKR
    - Investigational Site Number 032005
  - San Miguel De Tucuman, Argentina, T4000CHE
    - Investigational Site Number 032012
  - San Miguel De Tucumán, Argentina, T4000IAR
    - Investigational Site Number 032009
Australia
- - Adelaide, Australia, 5000
    - Investigational Site Number 036004
  - Campbelltown, Australia, 2560
    - Investigational Site Number 036005
  - Clayton, Australia, 3168
    - Investigational Site Number 036001
  - Frankston, Australia, 3199
    - Investigational Site Number 036008
  - Murdoch, Australia, 6150
    - Investigational Site Number 036093
  - Nedlands, Australia, 6009
    - Investigational Site Number 036003
  - Parkville, Australia, 3050
    - Investigational Site Number 036094
  - Prahran, Australia, 3004
    - Investigational Site Number 036009
  - Woolloongabba, Australia, 4102
    - Investigational Site Number 036006
Belgium
- - Brussels, Belgium, 1020
    - Investigational Site Number 056002
  - Gent, Belgium, 9000
    - Investigational Site Number 056003
  - Leuven, Belgium, 3000
    - Investigational Site Number 056001
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
  - Sorocaba, Brazil, 18040-425
    - Investigational Site Number 076002
  - São Bernardo Do Campo, Brazil, 09715-090
    - Investigational Site Number 076013
  - São Paulo, Brazil, 05437-000
    - Investigational Site Number 076006
Canada
- - Burlington, Canada, L7N 3V2
    - Investigational Site Number 124019
  - Calgary, Canada, T2N 4Z6
    - Investigational Site Number 124009
  - Hamilton, Canada, L8N 4A6
    - Investigational Site Number 124016
  - Mississauga, Canada, L5A 3V4
    - Investigational Site Number 124003
  - Montreal, Canada, H2X 3E4
    - 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
  - Vancouver, Canada, V6Z 1Y6
    - Investigational Site Number 124017
Chile
- - Quillota, Chile, 2260877
    - Investigational Site Number 152007
  - Santiago, Chile, 7500588
    - Investigational Site Number 152024
  - Santiago, Chile, 7500692
    - Investigational Site Number 152005
  - Santiago, Chile, 7500698
    - Investigational Site Number 152014
  - Santiago, Chile, 7500710
    - Investigational Site Number 152011
  - Santiago, Chile, 8207257
    - Investigational Site Number 152018
  - Santiago, Chile, 8380456
    - Investigational Site Number 152002
  - Santiago, Chile, 8910131
    - Investigational Site Number 152013
  - Talca, Chile, 3460001
    - Investigational Site Number 152008
  - Talca, Chile
    - Investigational Site Number 152004
  - Talcahuano, Chile
    - Investigational Site Number 152023
  - Valdivia, Chile, 5090145
    - Investigational Site Number 152010
  - Viña Del Mar, Chile, 2520024
    - Investigational Site Number 152003
  - Viña Del Mar, Chile, 2520594
    - Investigational Site Number 152021
Colombia
- - Bogota, Colombia, 110121
    - Investigational Site Number 170001
  - Bogotá, Colombia, 110231
    - Investigational Site Number 170002
Denmark
- - Hvidovre, Denmark, 2650
    - Investigational Site Number 208002
  - København Nv, Denmark, 2400
    - Investigational Site Number 208001
France
- - Brest, France, 29609
    - Investigational Site Number 250009
  - La Tronche, France, 38700
    - Investigational Site Number 250004
  - Lille Cedex, France, 59037
    - Investigational Site Number 250010
  - Lille Cedex, France, 59037
    - Investigational Site Number 250013
  - Lyon, France, 69317
    - Investigational Site Number 250006
  - Marseille, France, 13015
    - Investigational Site Number 250001
  - Montpellier, France, 34295
    - Investigational Site Number 250002
  - Nantes, France, 44033
    - Investigational Site Number 250005
  - Nimes Cedex 9, France, 30029
    - Investigational Site Number 250007
  - Strasbourg, France, 67091
    - Investigational Site Number 250008
  - Vandoeuvre-Les-Nancy Cedex, 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
  - Großhansdorf, Germany, 22927
    - Investigational Site Number 276011
  - Koblenz, Germany, 56068
    - Investigational Site Number 276009
  - Rüdersdorf Bei Berlin, Germany, 15562
    - Investigational Site Number 276005
Hungary
- - Balassagyarmat, Hungary, 2660
    - Investigational Site Number 348301
  - Edelény, Hungary, 3780
    - Investigational Site Number 348303
  - Gödöllö, Hungary, 2100
    - Investigational Site Number 348003
Israel
- - Haifa, Israel, 34362
    - Investigational Site Number 376003
  - Kfar Saba, Israel, 44281
    - Investigational Site Number 376001
  - Petah-Tikva, Israel, 49100
    - Investigational Site Number 376005
  - Rehovot, Israel, 76100
    - Investigational Site Number 376002
Italy
- - Ancona, Italy, 60126
    - Investigational Site Number 380010
  - Catania, Italy, 95123
    - Investigational Site Number 380009
  - Ferrara, Italy, 44124
    - Investigational Site Number 380004
  - Foggia, Italy, 71100
    - Investigational Site Number 380008
  - Genova, Italy, 16132
    - Investigational Site Number 380002
  - Modena, Italy, 41124
    - Investigational Site Number 380003
  - Padova, Italy, 35128
    - Investigational Site Number 380007
  - Palermo, Italy, 90146
    - Investigational Site Number 380099
  - Pisa, Italy, 56100
    - Investigational Site Number 380001
Japan
- - Akashi-Shi, Japan
    - Investigational Site Number 392185
  - Asahi-Shi, Japan
    - Investigational Site Number 392009
  - Chiyoda-Ku, Japan
    - Investigational Site Number 392037
  - Chuo-Ku, Japan
    - Investigational Site Number 392007
  - Chuo-Ku, Japan
    - Investigational Site Number 392002
  - Chuo-Ku, Japan
    - Investigational Site Number 392112
  - Edogawa-Ku, Japan
    - Investigational Site Number 392012
  - Fukuoka-Shi, Japan
    - Investigational Site Number 392137
  - Fukuyama-Shi, Japan
    - Investigational Site Number 392021
  - Habikino-Shi, Japan
    - Investigational Site Number 392030
  - Himeji-Shi, Japan
    - Investigational Site Number 392004
  - Hirakata-Shi, Japan
    - Investigational Site Number 392032
  - Hiroshima-Shi, Japan
    - Investigational Site Number 392108
  - Hiroshima-Shi, Japan
    - Investigational Site Number 392158
  - Iizuka-Shi, Japan
    - Investigational Site Number 392013
  - Isesaki-Shi, Japan
    - Investigational Site Number 392042
  - Kanazawa-Shi, Japan
    - Investigational Site Number 392023
  - Kasuga-Shi, Japan
    - Investigational Site Number 392142
  - Kishiwada-Shi, Japan
    - Investigational Site Number 392119
  - Kobe-Shi, Japan
    - Investigational Site Number 392025
  - Kobe-Shi, Japan
    - Investigational Site Number 392162
  - Kodaira-Shi, Japan
    - Investigational Site Number 392040
  - Kokubunji-Shi, Japan
    - Investigational Site Number 392044
  - Koushi-Shi, Japan
    - Investigational Site Number 392131
  - Kurashiki-Shi, Japan
    - Investigational Site Number 392010
  - Kyoto-Shi, Japan
    - Investigational Site Number 392036
  - Kyoto-Shi, Japan
    - Investigational Site Number 392153
  - Machida-Shi, Japan
    - Investigational Site Number 392133
  - Matsuyama-Shi, Japan
    - Investigational Site Number 392135
  - Minato-Ku, Japan
    - Investigational Site Number 392122
  - Minato-Ku, Japan
    - Investigational Site Number 392144
  - Mizunami-Shi, Japan
    - Investigational Site Number 392106
  - Muroran-Shi, Japan
    - Investigational Site Number 392164
  - Nagoya-Shi, Japan
    - Investigational Site Number 392163
  - Naka-Gun, Japan
    - Investigational Site Number 392020
  - Naruto-Shi, Japan
    - Investigational Site Number 392005
  - 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-Shi, Japan
    - Investigational Site Number 392043
  - Sagamihara-Shi, Japan
    - Investigational Site Number 392169
  - Sakai-Shi, Japan
    - Investigational Site Number 392024
  - Sakaide-Shi, Japan
    - Investigational Site Number 392011
  - Sapporo-Shi, Japan
    - Investigational Site Number 392008
  - Sapporo-Shi, Japan
    - Investigational Site Number 392034
  - Setagaya-Ku, Japan
    - Investigational Site Number 392038
  - Seto-Shi, Japan
    - Investigational Site Number 392179
  - Shibuya-Ku, Japan
    - Investigational Site Number 392186
  - Shinagawa-Ku, Japan
    - Investigational Site Number 392167
  - 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
  - Tomakomai-Shi, Japan
    - Investigational Site Number 392006
  - Tsu-Shi, Japan
    - Investigational Site Number 392029
  - Uozu-Shi, Japan
    - Investigational Site Number 392168
  - Urasoe-Shi, Japan
    - Investigational Site Number 392132
  - Uruma-Shi, Japan
    - Investigational Site Number 392045
  - Yokohama-Shi, Japan
    - Investigational Site Number 392014
Korea, Republic of
- - Bucheon-Si, Korea, Republic of, 14584
    - Investigational Site Number 410002
  - 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, 03312
    - Investigational Site Number 410008
  - 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
  - Suwon, Korea, Republic of, 16499
    - Investigational Site Number 410001
Mexico
- - Chihuahua, Mexico, 31020
    - Investigational Site Number 484013
  - Chihuahua, Mexico, 31200
    - Investigational Site Number 484006
  - Cuautitlan Izcalli, Mexico, 54769
    - Investigational Site Number 484014
  - Distrito Federal, Mexico, 07760
    - Investigational Site Number 484005
  - 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
Netherlands
- - Arnhem, Netherlands, 6815 AD
    - Investigational Site Number 528001
  - Dordrecht, Netherlands, 3318 AT
    - Investigational Site Number 528002
Poland
- - Bialystok, Poland, 15-010
    - Investigational Site Number 616006
  - Gdansk, Poland, 80-405
    - Investigational Site Number 616004
  - Gdansk, Poland, 80-952
    - Investigational Site Number 616003
  - Krakow, Poland, 31-159
    - Investigational Site Number 616007
  - Krakow, Poland, 31-159
    - Investigational Site Number 616097
  - 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 616096
  - Strzelce Opolskie, Poland, 47-100
    - Investigational Site Number 616098
  - Warszawa, Poland, 00-013
    - Investigational Site Number 616008
  - Warszawa, Poland, 04-141
    - Investigational Site Number 616010
  - Znin, Poland, 88-400
    - Investigational Site Number 616011
Romania
- - Bucharest, Romania, 011461
    - Investigational Site Number 642104
  - Bucharest, Romania, 050159
    - Investigational Site Number 642103
  - Cluj-Napoca, Romania, 400162
    - Investigational Site Number 642102
  - Cluj-Napoca, Romania, 400371
    - Investigational Site Number 642107
  - Timisoara, Romania, 300310
    - Investigational Site Number 642105
  - Timisoara, Romania, 300310
    - Investigational Site Number 642106
Russian Federation
- - Ekaterinburg, Russian Federation, 620028
    - Investigational Site Number 643013
  - Moscow, Russian Federation, 105077
    - Investigational Site Number 643096
  - Moscow, Russian Federation, 109240
    - Investigational Site Number 643002
  - Moscow, Russian Federation, 115280
    - Investigational Site Number 643005
  - Moscow, Russian Federation, 117574
    - Investigational Site Number 643007
  - Moscow, Russian Federation, 123182
    - Investigational Site Number 643012
  - Moscow, Russian Federation, 125315
    - Investigational Site Number 643001
  - Novosibirsk, Russian Federation, 630091
    - Investigational Site Number 643006
  - Ryazan, Russian Federation, 390039
    - Investigational Site Number 643091
  - Saint-Petersburg, Russian Federation, 194223
    - Investigational Site Number 643011
  - Saint-Petersburg, Russian Federation, 194354
    - Investigational Site Number 643010
  - St-Petersburg, Russian Federation, 193231
    - Investigational Site Number 643099
  - St-Petersburg, Russian Federation, 197022
    - Investigational Site Number 643009
  - Yaroslavl, Russian Federation, 150003
    - Investigational Site Number 643008
South Africa
- - Brandfort, South Africa, 9400
    - Investigational Site Number 710009
  - Cape Town, South Africa, 7505
    - Investigational Site Number 710011
  - Cape Town, South Africa, 7530
    - Investigational Site Number 710001
  - Cape Town, South Africa, 7700
    - Investigational Site Number 710091
  - Cape Town, South Africa, 7700
    - Investigational Site Number 710092
  - Cape Town, South Africa, 7764
    - Investigational Site Number 710002
  - Cape Town, South Africa, 8000
    - Investigational Site Number 710003
  - Durban, South Africa, 4071
    - Investigational Site Number 710006
  - Pretoria, South Africa, 0087
    - Investigational Site Number 710007
Spain
- - Barcelona, Spain, 08036
    - Investigational Site Number 724001
  - Barcelona, Spain, 08023
    - Investigational Site Number 724014
  - Barcelona, Spain, 08035
    - Investigational Site Number 724002
  - Palma De Mallorca, Spain, 07120
    - Investigational Site Number 724010
  - Pozuelo De Alarcón, Spain, 28223
    - Investigational Site Number 724006
  - Sabadell, Spain, 08208
    - Investigational Site Number 724003
  - Sant Boi De Llobregat, Spain, 08830
    - Investigational Site Number 724007
  - Santiago De Compostela, Spain, 15706
    - Investigational Site Number 724096
  - Sevilla, Spain, 41071
    - Investigational Site Number 724008
  - Valencia, Spain, 46017
    - Investigational Site Number 724097
Taiwan
- - New Taipei City, Taiwan, 23561
    - Investigational Site Number 158008
  - Taichung, Taiwan, 40447
    - Investigational Site Number 158007
  - Taipei, Taiwan, 11031
    - Investigational Site Number 158009
Turkey
- - Ankara, Turkey, 06100
    - Investigational Site Number 792002
  - Ankara, Turkey, 06100
    - Investigational Site Number 792098
  - Bursa, Turkey, 16059
    - Investigational Site Number 792008
  - Istanbul, Turkey, 34020
    - Investigational Site Number 792007
  - Istanbul, Turkey, 34098
    - Investigational Site Number 792001
  - Istanbul, Turkey, 34098
    - Investigational Site Number 792004
  - Istanbul, Turkey, 34844
    - Investigational Site Number 792003
  - Izmir, Turkey, 35040
    - Investigational Site Number 792005
  - Izmir, Turkey, 35110
    - Investigational Site Number 792090
  - Kirikkale, Turkey, 71450
    - Investigational Site Number 792013
  - Mersin, Turkey, 33070
    - Investigational Site Number 792006
  - Rize, Turkey, 53100
    - Investigational Site Number 792096
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 804094
  - Kharkiv, Ukraine, 61058
    - Investigational Site Number 804005
  - Kharkiv, Ukraine, 61093
    - Investigational Site Number 804021
  - Kharkiv, Ukraine, 61124
    - Investigational Site Number 804001
  - Kyiv, Ukraine, 03049
    - Investigational Site Number 804004
  - Kyiv, Ukraine, 03680
    - Investigational Site Number 804003
  - Kyiv, Ukraine, 03680
    - Investigational Site Number 804008
  - Kyiv, Ukraine, 03680
    - Investigational Site Number 804017
  - Kyiv, Ukraine, 03680
    - Investigational Site Number 804018
  - Kyiv, Ukraine, 03680
    - Investigational Site Number 804020
  - Kyiv, Ukraine, 04050
    - Investigational Site Number 804016
  - Odesa, 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 804019
  - Yalta, Ukraine, 298603
    - Investigational Site Number 804015
  - Zaporizhzhya, Ukraine, 69076
    - Investigational Site Number 804022
  - Zaporizhzhya, Ukraine, 69118
    - Investigational Site Number 804012
United Kingdom
- - Bradford, United Kingdom, BD9 6RJ
    - Investigational Site Number 826001
  - London, United Kingdom, W2 1NY
    - Investigational Site Number 826010
  - Oxford, United Kingdom, OX3 7LE
    - Investigational Site Number 826009
  - Portsmouth, United Kingdom, PO6 3LY
    - Investigational Site Number 826007
  - South Shields, United Kingdom, NE34 0PL
    - Investigational Site Number 826006
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Investigational Site Number 840047
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Investigational Site Number 840099
  - Scottsdale, Arizona, United States, 85251
    - Investigational Site Number 840087
  - Tucson, Arizona, United States, 85724
    - Investigational Site Number 840402
- Arkansas
  - Little Rock, Arkansas, United States, 72209
    - Investigational Site Number 840132
- California
  - Bakersfield, California, United States, 93301
    - Investigational Site Number 840109
  - Long Beach, California, United States, 90720
    - Investigational Site Number 840045
  - Los Angeles, California, United States, 90025
    - Investigational Site Number 840019
  - Los Angeles, California, United States, 90025
    - Investigational Site Number 840029
  - Los Angeles, California, United States, 90048
    - Investigational Site Number 840022
  - Newport Beach, California, United States, 92663
    - Investigational Site Number 840044
  - North Hollywood, California, United States, 91606
    - Investigational Site Number 840041
  - Rolling Hills Estates, California, United States, 90274
    - Investigational Site Number 840014
  - San Jose, California, United States, 95117
    - Investigational Site Number 840121
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Investigational Site Number 840040
  - Denver, Colorado, United States, 80206
    - Investigational Site Number 840403
  - Denver, Colorado, United States, 80230
    - Investigational Site Number 840006
  - Denver, Colorado, United States, 80230
    - Investigational Site Number 840024
  - Denver, Colorado, United States, 80246
    - Investigational Site Number 840130
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Investigational Site Number 840902
- Florida
  - Aventura, Florida, United States, 33180
    - Investigational Site Number 840137
  - Gainesville, Florida, United States, 32607
    - Investigational Site Number 840071
  - Ocoee, Florida, United States, 34761
    - Investigational Site Number 840115
  - Sarasota, Florida, United States, 34239
    - Investigational Site Number 840055
- Idaho
  - Twin Falls, Idaho, United States, 83301
    - Investigational Site Number 840079
- Illinois
  - Chicago, Illinois, United States, 60611
    - Investigational Site Number 840101
- Kentucky
  - Fort Mitchell, Kentucky, United States, 41017
    - Investigational Site Number 840032
  - Louisville, Kentucky, United States, 40223-5440
    - Investigational Site Number 840017
  - Owensboro, Kentucky, United States, 42301
    - Investigational Site Number 840030
- Maine
  - Bangor, Maine, United States, 04401
    - Investigational Site Number 840064
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - Investigational Site Number 840052
  - Gaithersburg, Maryland, United States, 20878
    - Investigational Site Number 840073
  - Owings Mills, Maryland, United States, 21117
    - Investigational Site Number 840080
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Investigational Site Number 840401
- Minnesota
  - Minneapolis, Minnesota, United States, 55402
    - Investigational Site Number 840018
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Investigational Site Number 840002
  - Saint Louis, Missouri, United States, 63141
    - Investigational Site Number 840102
  - Saint Louis, Missouri, United States
    - Investigational Site Number 840093
- Montana
  - Missoula, Montana, United States, 59808
    - Investigational Site Number 840037
- Nebraska
  - Omaha, Nebraska, United States, 68124
    - Investigational Site Number 840078
  - Papillion, Nebraska, United States, 27103
    - Investigational Site Number 840004
- 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 840011
- New York
  - New York, New York, United States, 10029
    - Investigational Site Number 840065
- 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, 27401
    - Investigational Site Number 840107
  - High Point, North Carolina, United States, 27262
    - Investigational Site Number 840907
  - Winston-Salem, North Carolina, United States, 27157-1071
    - Investigational Site Number 840404
- Ohio
  - Cincinnati, Ohio, United States, 45236
    - Investigational Site Number 840015
  - Cincinnati, Ohio, United States, 45241
    - Investigational Site Number 840146
  - Middleburg Heights, Ohio, United States, 44130
    - Investigational Site Number 840049
  - Toledo, Ohio, United States, 43617
    - Investigational Site Number 840942
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - Investigational Site Number 840112
  - Tulsa, Oklahoma, United States, 74136
    - Investigational Site Number 840104
- Oregon
  - Medford, Oregon, United States, 97504
    - Investigational Site Number 840034
  - Portland, Oregon, United States, 97223
    - Investigational Site Number 840031
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18020
    - Investigational Site Number 840046
  - Hershey, Pennsylvania, United States, 17033
    - Investigational Site Number 840085
  - Philadelphia, Pennsylvania, United States, 19140
    - Investigational Site Number 840067
  - Pittsburgh, Pennsylvania, United States, 15213
    - Investigational Site Number 840928
  - Pittsburgh, Pennsylvania, United States, 15241
    - Investigational Site Number 840091
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - Investigational Site Number 840082
  - Greenville, South Carolina, United States, 29607
    - Investigational Site Number 840117
  - Spartanburg, South Carolina, United States, 29303
    - Investigational Site Number 840021
- Texas
  - Amarillo, Texas, United States, 79106
    - Investigational Site Number 840062
  - 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 840023
  - El Paso, Texas, United States, 79903
    - Investigational Site Number 840923
  - Fort Worth, Texas, United States, 76109
    - Investigational Site Number 840922
  - Fort Worth, Texas, United States, 76244
    - Investigational Site Number 840027
  - McKinney, Texas, United States, 75069
    - Investigational Site Number 840070
  - Plano, Texas, United States, 75093
    - Investigational Site Number 840118
  - San Antonio, Texas, United States, 78229
    - Investigational Site Number 840008
- 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
- Washington
  - Bellingham, Washington, United States, 98225
    - Investigational Site Number 840951

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

Genders Eligible for Study

All

Description

Inclusion criteria:

- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.

Exclusion criteria:

- Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant.

The above information was 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: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dupilumab treatment For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1* Dose every 2 weeks added to current controller medications. For participants coming from other studies: dupilumab 1 * Dose SC every 2 weeks added to current controller medications.	Drug: Dupilumab Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous Other Names: REGN668 SAR231893

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Time Frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)	An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product [IMP] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.	From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 5, 2014

Primary Completion (Actual)

October 11, 2019

Study Completion (Actual)

October 11, 2019

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LTS12551
2013-003856-19 (EudraCT Number)
U1111-1117-6745 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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Outcome Measure	Measure Description	Time Frame
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period Time Frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)	Criteria for potentially clinically significant vital sign abnormalities: Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg. Diastolic blood pressure (DBP): ≤ 45 Adults (≤54 Adolescents) mmHg and DFB ≥ 10 mmHg; ≥ 110 Adults (≥78 Adolescents) mmHg and IFB ≥ 10 mmHg. Heart rate (HR): ≤ 50 beats per minute (bpm) and DFB ≥ 20 bpm; ≥ 120 bpm and IFB ≥ 20 bpm. Respiratory rate: less than (<) 12 breaths/min(b/m); greater than (>) 20 b/m. Weight (kg): ≥ 5 percent (%) DFB; ≥ 5% IFB. Temperature: ≥ 38.0 degree Celsius (°C) rectal/ear/temporal; ≥ 37.5°C oral; ≥ 37.2°C axillary. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.	From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period Time Frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)	Criteria for potentially clinically significant abnormalities: Hemoglobin (Hb): ≤ 115 grams per liter (g/L)(Male [M]), ≤ 95 g/L (Female[ F]) (< 100 g/L Adolescents); ≥ 185 g/L (M), ≥ 165 g/L (F) (≥ 200 g/L Adolescents); DFB ≥ 20 g/L. Hematocrit: ≤ 0.37 volume/volume (v/v) (M); ≤ 0.32 v/v (F) (<0.32 v/v Adolescents); ≥ 0.55 v/v (M); 0.5 v/v (F) (>0.47 v/v Adolescents). RBCs: ≥ 6 Tera/L. Platelets: < 100 Giga(G)/L; ≥ 700 G/L. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.	From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Number of Severe Exacerbation Events Time Frame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)	Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for ≥ 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for ≥3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids.	From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Annualized Event Rate Per Participant-Years for Severe Exacerbation Time Frame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)	The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period.	From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 Time Frame: Baseline of parent study, Week 48, and Week 96 of this extension study	FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 Time Frame: Baseline of parent study, Week 48, and Week 96 of this extension study	FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 Time Frame: Baseline of parent study, Weeks 24, and 48 of this extension study	The ACQ-5 had 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 mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Weeks 24, and 48 of this extension study
Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 Time Frame: At Weeks 24, and 48 of this extension study	ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 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 mean 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.	At Weeks 24, and 48 of this extension study
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 Time Frame: Baseline of parent study, Weeks 24, and 48 of this extension study	The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Weeks 24, and 48 of this extension study
Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 Time Frame: At Weeks 24, and 48 of this extension study	AQLQ global response was defined as participants with change from baseline in AQLQ global score ≥ 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). 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). Higher scores indicated better quality of life.	At Weeks 24, and 48 of this extension study
Serum Concentrations of Dupilumab Over Time Till Week 96 Time Frame: Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study	For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.	Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Percentage of Participants With Antidrug Antibodies (ADA) Response Time Frame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)	ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as "30 to > 10,000", where low titer (< 1,000); moderate (1,000 ≤ titer ≤ 10,000) and high titer (> 10,000).	From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	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 ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime 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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48, and Week 96 of this extension study	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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.	Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48, and Week 96 of this extension study	The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.	Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691 Time Frame: Baseline of parent study, Weeks 48 and 96 of this extension study	OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.	Baseline of parent study, Weeks 48 and 96 of this extension study
Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691 Time Frame: Weeks 48 and 96 of this extension study	OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported.	Weeks 48 and 96 of this extension study
Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691 Time Frame: Weeks 48, and 96 of this extension study	OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure.	Weeks 48, and 96 of this extension study
Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544 Time Frame: Baseline of parent study, Week 48 and Week 96 of this extension study	EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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