Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Reslizumab

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1122AAK
    • Teva Investigational Site 20040
  • Buenos Aires, Argentina, C1426ABP
    • Teva Investigational Site 20033
  • Buenos Aires, Argentina
    • Teva Investigational Site 20035
  • Cordoba, Argentina, X5003DCE
    • Teva Investigational Site 20041
  • Lanus, Argentina, B1824 KAJ
    • Teva Investigational Site 20053
  • Mar Del Plata, Argentina, CP 7600
    • Teva Investigational Site 20037
  • Mendoza, Argentina, 5500
    • Teva Investigational Site 20036
  • Rosario, Argentina, 2000
    • Teva Investigational Site 20054
  • Rosario, Argentina, S2000DBS
    • Teva Investigational Site 20032
  • San Miguel de Tucuman, Argentina, T4000CHE
    • Teva Investigational Site 20046
  • San Rafael, Argentina, 5600
    • Teva Investigational Site 20045
• Australia
  • Bedford Park, Australia, 5042
    • Teva Investigational Site 78085
  • Nedlands, Australia, 6009
    • Teva Investigational Site 78083
  • Parkville, Australia, 3052
    • Teva Investigational Site 78088
  • Sherwood, Australia, 4075
    • Teva Investigational Site 78087
  • Woolloongabba, Australia
    • Teva Investigational Site 78084
• Belgium
  • Bruxelles, Belgium, 1200
    • Teva Investigational Site 37054
  • Erpent, Belgium, 5101
    • Teva Investigational Site 37053
  • Gent, Belgium, 9000
    • Teva Investigational Site 37055
• Canada
  • Windsor, Canada, N8X 5A6
    • Teva Investigational Site 11109
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Teva Investigational Site 11106
  • Ontario
    • Etobicoke, Ontario, Canada, M9V 4B4
      • Teva Investigational Site 11105
• Czechia
  • Jablonec nad Nisou, Czechia, 46601
    • Teva Investigational Site 54130
  • Jindrichuv Hradec, Czechia, 377 01
    • Teva Investigational Site 54128
  • Tabor, Czechia, 39001
    • Teva Investigational Site 54129
• France
  • Strasbourg, France, 67091
    • Teva Investigational Site 35182
  • Toulouse, France, 31000
    • Teva Investigational Site 35183
• Germany
  • Bad Worishofen, Germany, 86825
    • Teva Investigational Site 32559
  • Berlin, Germany, 10717
    • Teva Investigational Site 32556
  • Berlin, Germany, 10969
    • Teva Investigational Site 32561
  • Berlin, Germany, 12159
    • Teva Investigational Site 32570
  • Berlin, Germany, 13507
    • Teva Investigational Site 32567
  • Berlin, Germany, 14059
    • Teva Investigational Site 32564
  • Frankfurt, Germany, 60389
    • Teva Investigational Site 32568
  • Frankfurt am Main, Germany, 60596
    • Teva Investigational Site 32560
  • Hamburg, Germany, 22299
    • Teva Investigational Site 32562
  • Hannover, Germany, 30173
    • Teva Investigational Site 32566
  • Koblenz, Germany, 56068
    • Teva Investigational Site 32555
  • Leipzig, Germany, 04357
    • Teva Investigational Site 32563
  • Leipzig, Germany, 4275
    • Teva Investigational Site 32557
  • Lubeck, Germany, 23552
    • Teva Investigational Site 32565
  • Mainz, Germany, 55131
    • Teva Investigational Site 32551
  • Witten, Germany, 58452
    • Teva Investigational Site 32569
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Teva Investigational Site 51216
  • Budapest, Hungary, H-1036
    • Teva Investigational Site 51228
  • Csorna, Hungary, 9300
    • Teva Investigational Site 51221
  • Debrecen, Hungary, 4032
    • Teva Investigational Site 51220
  • Debrecen, Hungary, 4032
    • Teva Investigational Site 51223
  • Dombovar, Hungary, 7200
    • Teva Investigational Site 51255
  • Godollo, Hungary, 2100
    • Teva Investigational Site 51218
  • Gyor, Hungary, 9023
    • Teva Investigational Site 51222
  • Hajdunanas, Hungary, 4080
    • Teva Investigational Site 51227
  • Kaposvar, Hungary, 7400
    • Teva Investigational Site 51226
  • Kapuvar, Hungary, 9330
    • Teva Investigational Site 51231
  • Szazhalombatta, Hungary, 2440
    • Teva Investigational Site 51224
  • Szeged, Hungary, 6725
    • Teva Investigational Site 51219
  • Szigetvar, Hungary, 7900
    • Teva Investigational Site 51225
  • Szombathely, Hungary
    • Teva Investigational Site 51217
  • Veszprem, Hungary, 8200
    • Teva Investigational Site 51229
• Israel
  • Ashkelon, Israel, 7830604
    • Teva Investigational Site 80077
  • Haifa, Israel, 3436212
    • Teva Investigational Site 80076
  • Jerusalem, Israel, 91031
    • Teva Investigational Site 80094
  • Jerusalem, Israel, 91120
    • Teva Investigational Site 80078
  • Kfar Saba, Israel, 44281
    • Teva Investigational Site 80080
  • Petach Tikva, Israel, 49100
    • Teva Investigational Site 80073
  • Petah Tikva, Israel, 49100
    • Teva Investigational Site 80081
  • Ramat Gan, Israel, 5262160
    • Teva Investigational Site 80079
  • Rehovot, Israel, 76100
    • Teva Investigational Site 80075
• Japan
  • Amagasaki, Japan, 660-8550
    • Teva Investigational Site 84039
  • Ginowan, Japan, 901-2214
    • Teva Investigational Site 84053
  • Hakodate, Japan, ?040-8611
    • Teva Investigational Site 84049
  • Hiroshima, Japan, 734-8530
    • Teva Investigational Site 84034
  • Kanazawa-shi, Japan, 920-8530
    • Teva Investigational Site 84036
  • Kishiwada-shi, Japan, 596-8501
    • Teva Investigational Site 84037
  • Kobe, Japan, 651-0073
    • Teva Investigational Site 84048
  • Kobe, Japan, 651-2273
    • Teva Investigational Site 84044
  • Kodaira, Japan, 187-8510
    • Teva Investigational Site 84047
  • Kumamoto, Japan, 862-0965
    • Teva Investigational Site 84045
  • Mizunami-shi, Japan, 509-6134
    • Teva Investigational Site 84043
  • Sagamihara, Japan, 252-5188
    • Teva Investigational Site 84041
  • Tokyo, Japan, 103-0027
    • Teva Investigational Site 84031
  • Tokyo, Japan, 103-0027
    • Teva Investigational Site 84032
  • Toyama, Japan, 930-8550
    • Teva Investigational Site 84046
  • Toyama-shi, Japan, 930-0194
    • Teva Investigational Site 84038
  • Toyoake-shi, Japan, 470-1192
    • Teva Investigational Site 84035
  • Yokohama-shi, Japan, 231-8682
    • Teva Investigational Site 84040
• Korea, Republic of
  • Bucheon, Korea, Republic of, 420-767
    • Teva Investigational Site 87015
  • Seoul, Korea, Republic of, 152-703
    • Teva Investigational Site 87016
  • Seoul, Korea, Republic of, 152703
    • Teva Investigational Site 87014
• Mexico
  • Guadalajara, Mexico, 44100
    • Teva Investigational Site 21084
  • Guadalajara, Mexico, 44130
    • Teva Investigational Site 21085
  • Guadalajara, Mexico, 44160
    • Teva Investigational Site 21088
  • Guadalajara, Mexico, 44220
    • Teva Investigational Site 21089
  • Monterrey, Mexico, 64718
    • Teva Investigational Site 21087
  • Zapopan, Mexico, 45070
    • Teva Investigational Site 21086
• New Zealand
  • Auckland, New Zealand, 1640
    • Teva Investigational Site 79047
  • Auckland, New Zealand
    • Teva Investigational Site 79046
• Poland
  • Bialystok, Poland, 15-044
    • Teva Investigational Site 53310
  • Bialystok, Poland, 15-276
    • Teva Investigational Site 53315
  • Gdansk, Poland, 80-952
    • Teva Investigational Site 53308
  • Krakow, Poland, 31-624
    • Teva Investigational Site 53311
  • Lodz, Poland, 90-153
    • Teva Investigational Site 53314
  • Lodz, Poland, 90-329
    • Teva Investigational Site 53312
  • Poznan, Poland, 60-214
    • Teva Investigational Site 53313
  • Tarnow, Poland, 33-100
    • Teva Investigational Site 53309
• Romania
  • Brasov, Romania, 500051
    • Teva Investigational Site 52108
  • Brasov, Romania, 500086
    • Teva Investigational Site 52109
  • Bucharest, Romania, 11461
    • Teva Investigational Site 52107
  • Bucharest, Romania, 50159
    • Teva Investigational Site 52105
  • Cluj-Napoca, Romania, 400371
    • Teva Investigational Site 52104
  • Deva, Romania
    • Teva Investigational Site 52111
  • Targu Mures, Romania, 540136
    • Teva Investigational Site 52106
  • Timisoara, Romania, 300310
    • Teva Investigational Site 52110
• Russian Federation
  • Barnaul, Russian Federation, 656024
    • Teva Investigational Site 50350
  • Kemerovo, Russian Federation, 650099
    • Teva Investigational Site 50354
  • Moscow, Russian Federation, 115478
    • Teva Investigational Site 50348
  • Moscow, Russian Federation, 119991
    • Teva Investigational Site 50351
  • Novosibirsk, Russian Federation, 630091
    • Teva Investigational Site 50347
  • Saint Petersburg, Russian Federation, 194356
    • Teva Investigational Site 50355
  • St. Petersburg, Russian Federation, 197089
    • Teva Investigational Site 50352
  • Tomsk, Russian Federation, 634063
    • Teva Investigational Site 50349
• South Africa
  • Benoni, South Africa, 1500
    • Teva Investigational Site 90027
  • Bloemfontein, South Africa, 9301
    • Teva Investigational Site 90028
  • Cape Town, South Africa, 7505
    • Teva Investigational Site 90026
  • Cape Town, South Africa, 7570
    • Teva Investigational Site 90031
  • Cape Town, South Africa, 7937
    • Teva Investigational Site 90029
  • Durban, South Africa, 4091
    • Teva Investigational Site 90032
  • Durban, South Africa, 4170
    • Teva Investigational Site 90030
• Spain
  • Barcelona, Spain, 08025
    • Teva Investigational Site 31149
  • Esplugues de Llobregat, Spain, 08950
    • Teva Investigational Site 31147
  • Girona, Spain, 17005
    • Teva Investigational Site 31152
  • Vitoria-Gasteiz, Spain, 01009
    • Teva Investigational Site 31154
• Turkey
  • Ankara, Turkey, 06290
    • Teva Investigational Site 82042
  • Izmir, Turkey, 35120
    • Teva Investigational Site 82041
  • Kocaeli, Turkey, 41380
    • Teva Investigational Site 82040
  • Konya, Turkey
    • Teva Investigational Site 82039
  • Mersin, Turkey, 33169
    • Teva Investigational Site 82043
• Ukraine
  • Chernivtsi, Ukraine, 58023
    • Teva Investigational Site 58216
  • Dnipropetrovsk, Ukraine, 49074
    • Teva Investigational Site 58219
  • Dnipropetrovsk, Ukraine, 49101
    • Teva Investigational Site 58225
  • Ivano-Frankivsk, Ukraine, 76018
    • Teva Investigational Site 58222
  • Kharkiv, Ukraine, 61002
    • Teva Investigational Site 58227
  • Kharkiv, Ukraine, 61007
    • Teva Investigational Site 58213
  • Kharkiv, Ukraine, 61035
    • Teva Investigational Site 58221
  • Kharkiv, Ukraine, 61039
    • Teva Investigational Site 58223
  • Kremenchuk, Ukraine, 39617
    • Teva Investigational Site 58214
  • Kryvyi Rih, Ukraine, 50082
    • Teva Investigational Site 58228
  • Kyiv, Ukraine, 03680
    • Teva Investigational Site 58220
  • Kyiv, Ukraine, 04050
    • Teva Investigational Site 58230
  • Kyiv, Ukraine, 04107
    • Teva Investigational Site 58218
  • Kyiv, Ukraine, 04201
    • Teva Investigational Site 58226
  • Kyiv, Ukraine, ?03680
    • Teva Investigational Site 58253
  • Sumy, Ukraine, 40022
    • Teva Investigational Site 58234
  • Vinnytsia, Ukraine, 21001
    • Teva Investigational Site 58233
  • Vinnytsya, Ukraine, 21001
    • Teva Investigational Site 58229
  • Zaporizhzhya, Ukraine, 69063
    • Teva Investigational Site 58231
  • Zhaporizhzhya, Ukraine, 69035
    • Teva Investigational Site 58224
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Teva Investigational Site 13212
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Teva Investigational Site 13241
  • Arkansas
    • Glendale, Arkansas, United States, 85306
      • Teva Investigational Site 13194
  • California
    • Bakersfield, California, United States, 93301
      • Teva Investigational Site 13215
    • Canoga Park, California, United States, 91303
      • Teva Investigational Site 13181
    • Fresno, California, United States, 93720
      • Teva Investigational Site 13254
    • Huntington Beach, California, United States, 92647
      • Teva Investigational Site 13216
    • Long Beach, California, United States, 90813
      • Teva Investigational Site 13247
    • Napa, California, United States, 94558
      • Teva Investigational Site 13205
    • San Jose, California, United States, 95117
      • Teva Investigational Site 13764
    • Stockton, California, United States, 95207
      • Teva Investigational Site 13252
    • Walnut Creek, California, United States, 94598
      • Teva Investigational Site 13251
  • Colorado
    • Denver, Colorado, United States, 80206
      • Teva Investigational Site 13229
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Teva Investigational Site 13766
  • Florida
    • Aventura, Florida, United States, 33180
      • Teva Investigational Site 13196
    • Fort Lauderdale, Florida, United States, 33308
      • Teva Investigational Site 13256
    • Kissimmee, Florida, United States, 34741
      • Teva Investigational Site 13203
    • Miami, Florida, United States, 33125
      • Teva Investigational Site 13197
    • Miami, Florida, United States, 33155
      • Teva Investigational Site 13220
    • Miami, Florida, United States, 33176
      • Teva Investigational Site 13243
    • New Port Richey, Florida, United States, 34653
      • Teva Investigational Site 13233
    • Orlando, Florida, United States, 32811
      • Teva Investigational Site 13201
    • Orlando, Florida, United States, 32819
      • Teva Investigational Site 13250
    • Pembroke Pines, Florida, United States, 33029
      • Teva Investigational Site 13246
    • Tallahassee, Florida, United States, 32308
      • Teva Investigational Site 13208
    • Tampa, Florida, United States, 33607
      • Teva Investigational Site 13255
  • Georgia
    • Albany, Georgia, United States, 31707
      • Teva Investigational Site 13765
    • Buford, Georgia, United States, 30518
      • Teva Investigational Site 13249
    • Lawrenceville, Georgia, United States, 30045
      • Teva Investigational Site 13763
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Teva Investigational Site 13230
    • Normal, Illinois, United States, 61761
      • Teva Investigational Site 13211
    • Shiloh, Illinois, United States, 62269
      • Teva Investigational Site 13235
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • Teva Investigational Site 13202
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Teva Investigational Site 13225
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Teva Investigational Site 13222
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Teva Investigational Site 13191
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Teva Investigational Site 13200
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Teva Investigational Site 13226
  • Missouri
    • Saint Louis, Missouri, United States, 63143
      • Teva Investigational Site 13204
  • Nebraska
    • Boys Town, Nebraska, United States, 68010
      • Teva Investigational Site 13258
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Teva Investigational Site 13769
    • Ocean City, New Jersey, United States, 07712
      • Teva Investigational Site 13210
  • New York
    • New Hyde Park, New York, United States, 11040
      • Teva Investigational Site 13188
    • New York, New York, United States, 10016
      • Teva Investigational Site 13232
    • New York, New York, United States, 11570
      • Teva Investigational Site 13767
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Teva Investigational Site 13186
    • Cleveland, Ohio, United States, 44106
      • Teva Investigational Site 13253
    • Toledo, Ohio, United States, 43606
      • Teva Investigational Site 13240
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Teva Investigational Site 13259
    • Oklahoma City, Oklahoma, United States, 73112
      • Teva Investigational Site 13238
  • Oregon
    • Medford, Oregon, United States, 97504
      • Teva Investigational Site 13195
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18020
      • Teva Investigational Site 13242
    • Jenkintown, Pennsylvania, United States, 19046
      • Teva Investigational Site 13218
    • Philadelphia, Pennsylvania, United States, 19107
      • Teva Investigational Site 13189
    • Pittsburgh, Pennsylvania, United States, 15241
      • Teva Investigational Site 13190
  • Rhode Island
    • East Providence, Rhode Island, United States, ?02914
      • Teva Investigational Site 13209
    • Lincoln, Rhode Island, United States, 02865
      • Teva Investigational Site 13217
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • Teva Investigational Site 13223
  • Texas
    • Arlington, Texas, United States, 76018
      • Teva Investigational Site 13185
    • Corsicana, Texas, United States, 75110
      • Teva Investigational Site 13199
    • Dallas, Texas, United States, 75225
      • Teva Investigational Site 13260
    • San Antonio, Texas, United States, 78229
      • Teva Investigational Site 13224
    • Waco, Texas, United States, 76712
      • Teva Investigational Site 13184
  • Utah
    • Provo, Utah, United States, 84604
      • Teva Investigational Site 13187
  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Teva Investigational Site 13207
    • Fairfax, Virginia, United States, 22030
      • Teva Investigational Site 13183
    • Falls Church, Virginia, United States, 22044
      • Teva Investigational Site 13257
    • Richmond, Virginia, United States, 23233
      • Teva Investigational Site 13239
  • Washington
    • Spokane, Washington, United States, 99204
      • Teva Investigational Site 13227

Participation Criteria

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:

• Written informed consent is obtained.
• The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
• The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
• The participant has required an inhaled corticosteroid.
• The participant has required an additional asthma controller medication besides inhaled corticosteroids.
• The participant has a history of asthma exacerbation.

• The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

  • Additional criteria may apply, please contact the investigator for more information

Exclusion Criteria:

• The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
• The participant has another confounding underlying lung disorder
• The participant has a known hypereosinophilic syndrome.
• The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
• The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
• The participant is a current smoker or has a smoking history.
• The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
• The participant was previously exposed to reslizumab.
• The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
• The participant has current or suspected drug and alcohol abuse.
• The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.

• The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.

  • Additional criteria may apply, please contact the investigator for more information

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching Placebo	Drug: Placebo; Matching Placebo
Experimental: Reslizumab	Drug: Reslizumab; Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment	A CAE was defined as a clinically-judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are presented as adjusted means. For this analysis, the offset variable is calculated as the logarithm of treatment duration minus the summed duration of exacerbations during the treatment period.	Day 1 to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Change in pre-bronchodilator FEV1 from baseline to week 52 is presented. FEV1 is a standard measurement of air movement in the lungs of participants with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.	Baseline, Week 52
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score	AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.	Baseline, Week 52
Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score	The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.	Baseline, Week 52
Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)	Asthma symptoms were recorded by participant each day and night in an asthma control diary. Night score was assessed on a 5-point scale where 0=no symptoms, slept through night, to 4=bad night, no sleep. Day score was assessed on a 6-point scale where 0=very well, no symptoms, to 5= asthma very severe, unable to carry out daily activities. Total asthma symptom score was calculated by taking the sum of the night and day asthma symptom scores recorded, ranging from 0 (no symptom) to 9 (severe symptom). A lower symptom score indicated a better outcome. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.	Baseline, Week 52
Percentage of Asthma Control Days	The percentage of asthma control days over 52 weeks of treatment is presented. An asthma control day was defined as a day on which the participant used less than or equal to 2 puffs of inhaled short-acting beta-agonist, had no nighttime awakenings, and experienced no asthma exacerbations. Analysis of the change from baseline to each visit was performed using a mixed effect MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.	Day 1 to Week 52
Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score	The SGRQ is a 17-item questionnaire with 50 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.	Baseline, Week 32
Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52	CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The KM method was used to estimate and compare the distributions of time to first CAE between treatment groups. Participants without an event during the treatment period were censored at either the date of the end of treatment (Week 52) visit for participants who completed treatment or at the date of last dose (+4 weeks) for participants who discontinued early.	Day 1 to Week 52
Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment	A CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The frequency of CAEs over 52-week treatment period is expressed as adjusted CAEs rate in 52 weeks. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.	Day 1 to Week 52
Number of Moderate Exacerbations During 52 Weeks of Treatment	A moderate exacerbation was defined as a clinically judged deterioration in asthma control as determined by investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention requiring additional asthma controller medication that was not a systemic corticosteroid and did not result in an asthma-specific hospitalization or emergency department visit (that is, a medical intervention that did not otherwise meet the criteria for primary endpoint). Frequency of moderate exacerbations over 52-week treatment period is expressed as adjusted exacerbation rate in 52 weeks. Adjusted exacerbation rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.	Day 1 to Week 52

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Collaborators: PPD

Publications and helpful links

General Publications

• Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2015
• Primary Completion (Actual): December 4, 2017
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Reslizumab
• Other Study ID Numbers: C38072-AS-30025; 2015-000865-29 (EudraCT Number)