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

NCT02452190 | Completed Phase 3 Results

• 2 other identifiers: C38072-AS-300252015-000865-29
• Study Type: interventional
• Target: 468
• Locations: 21 countries
• Sites: 226

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

  Baseline, Week 52

• Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score

  Baseline, Week 52

• Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score

  Baseline, Week 52

• Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)

  Baseline, Week 52

• Percentage of Asthma Control Days

  Day 1 to Week 52

Study Arms (2)

Reslizumab

EXPERIMENTAL

Reslizumab

Drug: Reslizumab

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

Reslizumab DRUG

Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.

Reslizumab

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• PPD Development, LP: collaborator

Study Sites (226)

Teva Investigational Site 13212

Birmingham, Alabama, 35209, United States

Location

Teva Investigational Site 13241

Flagstaff, Arizona, 86001, United States

Location

Teva Investigational Site 13194

Glendale, Arkansas, 85306, United States

Location

Teva Investigational Site 13215

Bakersfield, California, 93301, United States

Location

Teva Investigational Site 13181

Canoga Park, California, 91303, United States

Location

Teva Investigational Site 13254

Fresno, California, 93720, United States

Location

Teva Investigational Site 13216

Huntington Beach, California, 92647, United States

Location

Teva Investigational Site 13247

Long Beach, California, 90813, United States

Location

Teva Investigational Site 13205

Napa, California, 94558, United States

Location

Teva Investigational Site 13764

San Jose, California, 95117, United States

Location

Teva Investigational Site 13252

Stockton, California, 95207, United States

Location

Teva Investigational Site 13251

Walnut Creek, California, 94598, United States

Location

Teva Investigational Site 13229

Denver, Colorado, 80206, United States

Location

Teva Investigational Site 13766

Waterbury, Connecticut, 06708, United States

Location

Teva Investigational Site 13196

Aventura, Florida, 33180, United States

Location

Teva Investigational Site 13256

Fort Lauderdale, Florida, 33308, United States

Location

Teva Investigational Site 13203

Kissimmee, Florida, 34741, United States

Location

Teva Investigational Site 13197

Miami, Florida, 33125, United States

Location

Teva Investigational Site 13220

Miami, Florida, 33155, United States

Location

Teva Investigational Site 13243

Miami, Florida, 33176, United States

Location

Teva Investigational Site 13233

New Port Richey, Florida, 34653, United States

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Teva Investigational Site 13201

Orlando, Florida, 32811, United States

Location

Teva Investigational Site 13250

Orlando, Florida, 32819, United States

Location

Teva Investigational Site 13246

Pembroke Pines, Florida, 33029, United States

Location

Teva Investigational Site 13208

Tallahassee, Florida, 32308, United States

Location

Teva Investigational Site 13255

Tampa, Florida, 33607, United States

Location

Teva Investigational Site 13765

Albany, Georgia, 31707, United States

Location

Teva Investigational Site 13249

Buford, Georgia, 30518, United States

Location

Teva Investigational Site 13763

Lawrenceville, Georgia, 30045, United States

Location

Teva Investigational Site 13230

Chicago, Illinois, 60612, United States

Location

Teva Investigational Site 13211

Normal, Illinois, 61761, United States

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Teva Investigational Site 13235

Shiloh, Illinois, 62269, United States

Location

Teva Investigational Site 13202

Michigan City, Indiana, 46360, United States

Location

Teva Investigational Site 13225

Lenexa, Kansas, 66215, United States

Location

Teva Investigational Site 13222

Owensboro, Kentucky, 42301, United States

Location

Teva Investigational Site 13191

Lafayette, Louisiana, 70503, United States

Location

Teva Investigational Site 13200

North Dartmouth, Massachusetts, 02747, United States

Location

Teva Investigational Site 13226

Biloxi, Mississippi, 39531, United States

Location

Teva Investigational Site 13204

St Louis, Missouri, 63143, United States

Location

Teva Investigational Site 13258

Boys Town, Nebraska, 68010, United States

Location

Teva Investigational Site 13769

Belleville, New Jersey, 07109, United States

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Teva Investigational Site 13210

Ocean City, New Jersey, 07712, United States

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Teva Investigational Site 13188

New Hyde Park, New York, 11040, United States

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Teva Investigational Site 13232

New York, New York, 10016, United States

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Teva Investigational Site 13767

New York, New York, 11570, United States

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Teva Investigational Site 13186

Cincinnati, Ohio, 45267, United States

Location

Teva Investigational Site 13253

Cleveland, Ohio, 44106, United States

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Teva Investigational Site 13240

Toledo, Ohio, 43606, United States

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Teva Investigational Site 13259

Edmond, Oklahoma, 73034, United States

Location

Teva Investigational Site 13238

Oklahoma City, Oklahoma, 73112, United States

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Teva Investigational Site 13195

Medford, Oregon, 97504, United States

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Teva Investigational Site 13242

Bethlehem, Pennsylvania, 18020, United States

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Teva Investigational Site 13218

Jenkintown, Pennsylvania, 19046, United States

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Teva Investigational Site 13189

Philadelphia, Pennsylvania, 19107, United States

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Teva Investigational Site 13190

Pittsburgh, Pennsylvania, 15241, United States

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Teva Investigational Site 13209

East Providence, Rhode Island, ?02914, United States

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Teva Investigational Site 13217

Lincoln, Rhode Island, 02865, United States

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Teva Investigational Site 13223

Knoxville, Tennessee, 37919, United States

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Teva Investigational Site 13185

Arlington, Texas, 76018, United States

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Teva Investigational Site 13199

Corsicana, Texas, 75110, United States

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Teva Investigational Site 13260

Dallas, Texas, 75225, United States

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Teva Investigational Site 13224

San Antonio, Texas, 78229, United States

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Teva Investigational Site 13184

Waco, Texas, 76712, United States

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Teva Investigational Site 13187

Provo, Utah, 84604, United States

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Teva Investigational Site 13207

Abingdon, Virginia, 24210, United States

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Teva Investigational Site 13183

Fairfax, Virginia, 22030, United States

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Teva Investigational Site 13257

Falls Church, Virginia, 22044, United States

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Teva Investigational Site 13239

Richmond, Virginia, 23233, United States

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Teva Investigational Site 13227

Spokane, Washington, 99204, United States

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Teva Investigational Site 20040

Buenos Aires, C1122AAK, Argentina

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Teva Investigational Site 20033

Buenos Aires, C1426ABP, Argentina

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Teva Investigational Site 20035

Buenos Aires, Argentina

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Teva Investigational Site 20041

Córdoba, X5003DCE, Argentina

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Teva Investigational Site 20053

Lanús, B1824 KAJ, Argentina

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Teva Investigational Site 20037

Mar del Plata, CP 7600, Argentina

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Teva Investigational Site 20036

Mendoza, 5500, Argentina

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Teva Investigational Site 20054

Rosario, 2000, Argentina

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Teva Investigational Site 20032

Rosario, S2000DBS, Argentina

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Teva Investigational Site 20046

San Miguel de Tucumán, T4000CHE, Argentina

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Teva Investigational Site 20045

San Rafael, 5600, Argentina

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Teva Investigational Site 78085

Bedford Park, 5042, Australia

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Teva Investigational Site 78083

Nedlands, 6009, Australia

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Teva Investigational Site 78088

Parkville, 3052, Australia

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Teva Investigational Site 78087

Sherwood, 4075, Australia

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Teva Investigational Site 78084

Woolloongabba, Australia

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Teva Investigational Site 37054

Brussels, 1200, Belgium

Location

Teva Investigational Site 37053

Erpent, 5101, Belgium

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Teva Investigational Site 37055

Ghent, 9000, Belgium

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Teva Investigational Site 11106

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Teva Investigational Site 11105

Etobicoke, Ontario, M9V 4B4, Canada

Location

Teva Investigational Site 11109

Windsor, N8X 5A6, Canada

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Teva Investigational Site 54130

Jablonec nad Nisou, 46601, Czechia

Location

Teva Investigational Site 54128

Jindřichův Hradec, 377 01, Czechia

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Teva Investigational Site 54129

Tábor, 39001, Czechia

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Teva Investigational Site 35182

Strasbourg, 67091, France

Location

Teva Investigational Site 35183

Toulouse, 31000, France

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Teva Investigational Site 32559

Bad Wörishofen, 86825, Germany

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Teva Investigational Site 32556

Berlin, 10717, Germany

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Teva Investigational Site 32561

Berlin, 10969, Germany

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Teva Investigational Site 32570

Berlin, 12159, Germany

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Teva Investigational Site 32567

Berlin, 13507, Germany

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Teva Investigational Site 32564

Berlin, 14059, Germany

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Teva Investigational Site 32568

Frankfurt, 60389, Germany

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Teva Investigational Site 32560

Frankfurt am Main, 60596, Germany

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Teva Investigational Site 32562

Hamburg, 22299, Germany

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Teva Investigational Site 32566

Hanover, 30173, Germany

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Teva Investigational Site 32555

Koblenz, 56068, Germany

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Teva Investigational Site 32563

Leipzig, 04357, Germany

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Teva Investigational Site 32557

Leipzig, 4275, Germany

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Teva Investigational Site 32565

Lübeck, 23552, Germany

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Teva Investigational Site 32551

Mainz, 55131, Germany

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Teva Investigational Site 32569

Witten, 58452, Germany

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Teva Investigational Site 51216

Balassagyarmat, 2660, Hungary

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Teva Investigational Site 51228

Budapest, H-1036, Hungary

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Teva Investigational Site 51221

Csorna, 9300, Hungary

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Teva Investigational Site 51220

Debrecen, 4032, Hungary

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Teva Investigational Site 51223

Debrecen, 4032, Hungary

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Teva Investigational Site 51255

Dombóvár, 7200, Hungary

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Teva Investigational Site 51218

Gödöllő, 2100, Hungary

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Teva Investigational Site 51222

Győr, 9023, Hungary

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Teva Investigational Site 51227

Hajdúnánás, 4080, Hungary

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Teva Investigational Site 51226

Kaposvár, 7400, Hungary

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Teva Investigational Site 51231

Kapuvár, 9330, Hungary

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Teva Investigational Site 51224

Százhalombatta, 2440, Hungary

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Teva Investigational Site 51219

Szeged, 6725, Hungary

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Teva Investigational Site 51225

Szigetvár, 7900, Hungary

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Teva Investigational Site 51217

Szombathely, Hungary

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Teva Investigational Site 51229

Veszprém, 8200, Hungary

Location

Teva Investigational Site 80077

Ashkelon, 7830604, Israel

Location

Teva Investigational Site 80076

Haifa, 3436212, Israel

Location

Teva Investigational Site 80094

Jerusalem, 91031, Israel

Location

Teva Investigational Site 80078

Jerusalem, 91120, Israel

Location

Teva Investigational Site 80080

Kfar Saba, 44281, Israel

Location

Teva Investigational Site 80073

Petah Tikva, 49100, Israel

Location

Teva Investigational Site 80081

Petah Tikva, 49100, Israel

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Teva Investigational Site 80079

Ramat Gan, 5262160, Israel

Location

Teva Investigational Site 80075

Rehovot, 76100, Israel

Location

Teva Investigational Site 84039

Amagasaki, 660-8550, Japan

Location

Teva Investigational Site 84053

Ginowan, 901-2214, Japan

Location

Teva Investigational Site 84049

Hakodate, ?040-8611, Japan

Location

Teva Investigational Site 84034

Hiroshima, 734-8530, Japan

Location

Teva Investigational Site 84036

Kanazawa, 920-8530, Japan

Location

Teva Investigational Site 84037

Kishiwada-shi, 596-8501, Japan

Location

Teva Investigational Site 84048

Kobe, 651-0073, Japan

Location

Teva Investigational Site 84044

Kobe, 651-2273, Japan

Location

Teva Investigational Site 84047

Kodaira, 187-8510, Japan

Location

Teva Investigational Site 84045

Kumamoto, 862-0965, Japan

Location

Teva Investigational Site 84043

Mizunami-shi, 509-6134, Japan

Location

Teva Investigational Site 84041

Sagamihara, 252-5188, Japan

Location

Teva Investigational Site 84031

Tokyo, 103-0027, Japan

Location

Teva Investigational Site 84032

Tokyo, 103-0027, Japan

Location

Teva Investigational Site 84038

Toyama, 930-0194, Japan

Location

Teva Investigational Site 84046

Toyama, 930-8550, Japan

Location

Teva Investigational Site 84035

Toyoake-shi, 470-1192, Japan

Location

Teva Investigational Site 84040

Yokohama, 231-8682, Japan

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Teva Investigational Site 21084

Guadalajara, 44100, Mexico

Location

Teva Investigational Site 21085

Guadalajara, 44130, Mexico

Location

Teva Investigational Site 21088

Guadalajara, 44160, Mexico

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Teva Investigational Site 21089

Guadalajara, 44220, Mexico

Location

Teva Investigational Site 21087

Monterrey, 64718, Mexico

Location

Teva Investigational Site 21086

Zapopan, 45070, Mexico

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Teva Investigational Site 79047

Auckland, 1640, New Zealand

Location

Teva Investigational Site 79046

Auckland, New Zealand

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Teva Investigational Site 53310

Bialystok, 15-044, Poland

Location

Teva Investigational Site 53315

Bialystok, 15-276, Poland

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Teva Investigational Site 53308

Gdansk, 80-952, Poland

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Teva Investigational Site 53311

Krakow, 31-624, Poland

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Teva Investigational Site 53314

Lodz, 90-153, Poland

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Teva Investigational Site 53312

Lodz, 90-329, Poland

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Teva Investigational Site 53313

Poznan, 60-214, Poland

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Teva Investigational Site 53309

Tarnów, 33-100, Poland

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Teva Investigational Site 52108

Brasov, 500051, Romania

Location

Teva Investigational Site 52109

Brasov, 500086, Romania

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Teva Investigational Site 52107

Bucharest, 11461, Romania

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Teva Investigational Site 52105

Bucharest, 50159, Romania

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Teva Investigational Site 52104

Cluj-Napoca, 400371, Romania

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Teva Investigational Site 52111

Deva, Romania

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Teva Investigational Site 52106

Târgu Mureş, 540136, Romania

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Teva Investigational Site 52110

Timișoara, 300310, Romania

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Teva Investigational Site 50350

Barnaul, 656024, Russia

Location

Teva Investigational Site 50354

Kemerovo, 650099, Russia

Location

Teva Investigational Site 50348

Moscow, 115478, Russia

Location

Teva Investigational Site 50351

Moscow, 119991, Russia

Location

Teva Investigational Site 50347

Novosibirsk, 630091, Russia

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Teva Investigational Site 50355

Saint Petersburg, 194356, Russia

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Teva Investigational Site 50352

Saint Petersburg, 197089, Russia

Location

Teva Investigational Site 50349

Tomsk, 634063, Russia

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Teva Investigational Site 90027

Benoni, 1500, South Africa

Location

Teva Investigational Site 90028

Bloemfontein, 9301, South Africa

Location

Teva Investigational Site 90026

Cape Town, 7505, South Africa

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Teva Investigational Site 90031

Cape Town, 7570, South Africa

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Teva Investigational Site 90029

Cape Town, 7937, South Africa

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Teva Investigational Site 90032

Durban, 4091, South Africa

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Teva Investigational Site 90030

Durban, 4170, South Africa

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Teva Investigational Site 87015

Bucheon-si, 420-767, South Korea

Location

Teva Investigational Site 87016

Seoul, 152-703, South Korea

Location

Teva Investigational Site 87014

Seoul, 152703, South Korea

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Teva Investigational Site 31149

Barcelona, 08025, Spain

Location

Teva Investigational Site 31147

Esplugues de Llobregat, 08950, Spain

Location

Teva Investigational Site 31152

Girona, 17005, Spain

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Teva Investigational Site 31154

Vitoria-Gasteiz, 01009, Spain

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Teva Investigational Site 82042

Ankara, 06290, Turkey (Türkiye)

Location

Teva Investigational Site 82041

Izmir, 35120, Turkey (Türkiye)

Location

Teva Investigational Site 82040

Kocaeli, 41380, Turkey (Türkiye)

Location

Teva Investigational Site 82039

Konya, Turkey (Türkiye)

Location

Teva Investigational Site 82043

Mersin, 33169, Turkey (Türkiye)

Location

Teva Investigational Site 58216

Chernivtsi, 58023, Ukraine

Location

Teva Investigational Site 58219

Dnipropetrovsk, 49074, Ukraine

Location

Teva Investigational Site 58225

Dnipropetrovsk, 49101, Ukraine

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Teva Investigational Site 58222

Ivano-Frankivsk, 76018, Ukraine

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Teva Investigational Site 58227

Kharkiv, 61002, Ukraine

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Teva Investigational Site 58213

Kharkiv, 61007, Ukraine

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Teva Investigational Site 58221

Kharkiv, 61035, Ukraine

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Teva Investigational Site 58223

Kharkiv, 61039, Ukraine

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Teva Investigational Site 58214

Kremenchuk, 39617, Ukraine

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Teva Investigational Site 58228

Kryvyi Rih, 50082, Ukraine

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Teva Investigational Site 58220

Kyiv, 03680, Ukraine

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Teva Investigational Site 58230

Kyiv, 04050, Ukraine

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Teva Investigational Site 58218

Kyiv, 04107, Ukraine

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Teva Investigational Site 58226

Kyiv, 04201, Ukraine

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Teva Investigational Site 58253

Kyiv, ?03680, Ukraine

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Teva Investigational Site 58234

Sumy, 40022, Ukraine

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Teva Investigational Site 58229

Vinnytsia, 21001, Ukraine

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Teva Investigational Site 58233

Vinnytsia, 21001, Ukraine

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Teva Investigational Site 58231

Zaporizhzhya, 69063, Ukraine

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Teva Investigational Site 58224

Zhaporizhzhya, 69035, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 32066536 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

reslizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 22, 2015
• Study Start: September 28, 2015
• Primary Completion: December 4, 2017
• Study Completion: January 31, 2018
• Last Updated: November 9, 2021
• Results First Posted: February 6, 2019

Record last verified: 2021-11

Locations

BE (3); TU (5); ES (4); JP (18); CA (3); DE (16); ME (6); FR (2); NZ (2); RO (8); PL (8); AU (5); HU (16); US (69); IL (9); UA (20); KR (3); CZ (3); AR (11); RU (8); ZA (7)