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

NCT ID: NCT02452190

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-28
• Study Completion Date: 2018-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reslizumab

Reslizumab

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: DRUG

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

Placebo

Matching Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Interventions

Reslizumab

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

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13212

Birmingham, Alabama, United States

Teva Investigational Site 13241

Flagstaff, Arizona, United States

Teva Investigational Site 13194

Glendale, Arkansas, United States

Teva Investigational Site 13215

Bakersfield, California, United States

Teva Investigational Site 13181

Canoga Park, California, United States

Teva Investigational Site 13254

Fresno, California, United States

Teva Investigational Site 13216

Huntington Beach, California, United States

Teva Investigational Site 13247

Long Beach, California, United States

Teva Investigational Site 13205

Napa, California, United States

Teva Investigational Site 13764

San Jose, California, United States

Teva Investigational Site 13252

Stockton, California, United States

Teva Investigational Site 13251

Walnut Creek, California, United States

Teva Investigational Site 13229

Denver, Colorado, United States

Teva Investigational Site 13766

Waterbury, Connecticut, United States

Teva Investigational Site 13196

Aventura, Florida, United States

Teva Investigational Site 13256

Fort Lauderdale, Florida, United States

Teva Investigational Site 13203

Kissimmee, Florida, United States

Teva Investigational Site 13197

Miami, Florida, United States

Teva Investigational Site 13220

Miami, Florida, United States

Teva Investigational Site 13243

Miami, Florida, United States

Teva Investigational Site 13233

New Port Richey, Florida, United States

Teva Investigational Site 13201

Orlando, Florida, United States

Teva Investigational Site 13250

Orlando, Florida, United States

Teva Investigational Site 13246

Pembroke Pines, Florida, United States

Teva Investigational Site 13208

Tallahassee, Florida, United States

Teva Investigational Site 13255

Tampa, Florida, United States

Teva Investigational Site 13765

Albany, Georgia, United States

Teva Investigational Site 13249

Buford, Georgia, United States

Teva Investigational Site 13763

Lawrenceville, Georgia, United States

Teva Investigational Site 13230

Chicago, Illinois, United States

Teva Investigational Site 13211

Normal, Illinois, United States

Teva Investigational Site 13235

Shiloh, Illinois, United States

Teva Investigational Site 13202

Michigan City, Indiana, United States

Teva Investigational Site 13225

Lenexa, Kansas, United States

Teva Investigational Site 13222

Owensboro, Kentucky, United States

Teva Investigational Site 13191

Lafayette, Louisiana, United States

Teva Investigational Site 13200

North Dartmouth, Massachusetts, United States

Teva Investigational Site 13226

Biloxi, Mississippi, United States

Teva Investigational Site 13204

St Louis, Missouri, United States

Teva Investigational Site 13258

Boys Town, Nebraska, United States

Teva Investigational Site 13769

Belleville, New Jersey, United States

Teva Investigational Site 13210

Ocean City, New Jersey, United States

Teva Investigational Site 13188

New Hyde Park, New York, United States

Teva Investigational Site 13232

New York, New York, United States

Teva Investigational Site 13767

New York, New York, United States

Teva Investigational Site 13186

Cincinnati, Ohio, United States

Teva Investigational Site 13253

Cleveland, Ohio, United States

Teva Investigational Site 13240

Toledo, Ohio, United States

Teva Investigational Site 13259

Edmond, Oklahoma, United States

Teva Investigational Site 13238

Oklahoma City, Oklahoma, United States

Teva Investigational Site 13195

Medford, Oregon, United States

Teva Investigational Site 13242

Bethlehem, Pennsylvania, United States

Teva Investigational Site 13218

Jenkintown, Pennsylvania, United States

Teva Investigational Site 13189

Philadelphia, Pennsylvania, United States

Teva Investigational Site 13190

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 13209

East Providence, Rhode Island, United States

Teva Investigational Site 13217

Lincoln, Rhode Island, United States

Teva Investigational Site 13223

Knoxville, Tennessee, United States

Teva Investigational Site 13185

Arlington, Texas, United States

Teva Investigational Site 13199

Corsicana, Texas, United States

Teva Investigational Site 13260

Dallas, Texas, United States

Teva Investigational Site 13224

San Antonio, Texas, United States

Teva Investigational Site 13184

Waco, Texas, United States

Teva Investigational Site 13187

Provo, Utah, United States

Teva Investigational Site 13207

Abingdon, Virginia, United States

Teva Investigational Site 13183

Fairfax, Virginia, United States

Teva Investigational Site 13257

Falls Church, Virginia, United States

Teva Investigational Site 13239

Richmond, Virginia, United States

Teva Investigational Site 13227

Spokane, Washington, United States

Teva Investigational Site 20040

Buenos Aires, , Argentina

Teva Investigational Site 20033

Buenos Aires, , Argentina

Teva Investigational Site 20035

Buenos Aires, , Argentina

Teva Investigational Site 20041

Córdoba, , Argentina

Teva Investigational Site 20053

Lanús, , Argentina

Teva Investigational Site 20037

Mar del Plata, , Argentina

Teva Investigational Site 20036

Mendoza, , Argentina

Teva Investigational Site 20054

Rosario, , Argentina

Teva Investigational Site 20032

Rosario, , Argentina

Teva Investigational Site 20046

San Miguel de Tucumán, , Argentina

Teva Investigational Site 20045

San Rafael, , Argentina

Teva Investigational Site 78085

Bedford Park, , Australia

Teva Investigational Site 78083

Nedlands, , Australia

Teva Investigational Site 78088

Parkville, , Australia

Teva Investigational Site 78087

Sherwood, , Australia

Teva Investigational Site 78084

Woolloongabba, , Australia

Teva Investigational Site 37054

Brussels, , Belgium

Teva Investigational Site 37053

Erpent, , Belgium

Teva Investigational Site 37055

Ghent, , Belgium

Teva Investigational Site 11106

Vancouver, British Columbia, Canada

Teva Investigational Site 11105

Etobicoke, Ontario, Canada

Teva Investigational Site 11109

Windsor, , Canada

Teva Investigational Site 54130

Jablonec nad Nisou, , Czechia

Teva Investigational Site 54128

Jindřichův Hradec, , Czechia

Teva Investigational Site 54129

Tábor, , Czechia

Teva Investigational Site 35182

Strasbourg, , France

Teva Investigational Site 35183

Toulouse, , France

Teva Investigational Site 32559

Bad Wörishofen, , Germany

Teva Investigational Site 32556

Berlin, , Germany

Teva Investigational Site 32561

Berlin, , Germany

Teva Investigational Site 32570

Berlin, , Germany

Teva Investigational Site 32567

Berlin, , Germany

Teva Investigational Site 32564

Berlin, , Germany

Teva Investigational Site 32568

Frankfurt, , Germany

Teva Investigational Site 32560

Frankfurt am Main, , Germany

Teva Investigational Site 32562

Hamburg, , Germany

Teva Investigational Site 32566

Hanover, , Germany

Teva Investigational Site 32555

Koblenz, , Germany

Teva Investigational Site 32563

Leipzig, , Germany

Teva Investigational Site 32557

Leipzig, , Germany

Teva Investigational Site 32565

Lübeck, , Germany

Teva Investigational Site 32551

Mainz, , Germany

Teva Investigational Site 32569

Witten, , Germany

Teva Investigational Site 51216

Balassagyarmat, , Hungary

Teva Investigational Site 51228

Budapest, , Hungary

Teva Investigational Site 51221

Csorna, , Hungary

Teva Investigational Site 51220

Debrecen, , Hungary

Teva Investigational Site 51223

Debrecen, , Hungary

Teva Investigational Site 51255

Dombóvár, , Hungary

Teva Investigational Site 51218

Gödöllő, , Hungary

Teva Investigational Site 51222

Győr, , Hungary

Teva Investigational Site 51227

Hajdúnánás, , Hungary

Teva Investigational Site 51226

Kaposvár, , Hungary

Teva Investigational Site 51231

Kapuvár, , Hungary

Teva Investigational Site 51224

Százhalombatta, , Hungary

Teva Investigational Site 51219

Szeged, , Hungary

Teva Investigational Site 51225

Szigetvár, , Hungary

Teva Investigational Site 51217

Szombathely, , Hungary

Teva Investigational Site 51229

Veszprém, , Hungary

Teva Investigational Site 80077

Ashkelon, , Israel

Teva Investigational Site 80076

Haifa, , Israel

Teva Investigational Site 80094

Jerusalem, , Israel

Teva Investigational Site 80078

Jerusalem, , Israel

Teva Investigational Site 80080

Kfar Saba, , Israel

Teva Investigational Site 80073

Petah Tikva, , Israel

Teva Investigational Site 80081

Petah Tikva, , Israel

Teva Investigational Site 80079

Ramat Gan, , Israel

Teva Investigational Site 80075

Rehovot, , Israel

Teva Investigational Site 84039

Amagasaki, , Japan

Teva Investigational Site 84053

Ginowan, , Japan

Teva Investigational Site 84049

Hakodate, , Japan

Teva Investigational Site 84034

Hiroshima, , Japan

Teva Investigational Site 84036

Kanazawa, , Japan

Teva Investigational Site 84037

Kishiwada-shi, , Japan

Teva Investigational Site 84048

Kobe, , Japan

Teva Investigational Site 84044

Kobe, , Japan

Teva Investigational Site 84047

Kodaira, , Japan

Teva Investigational Site 84045

Kumamoto, , Japan

Teva Investigational Site 84043

Mizunami-shi, , Japan

Teva Investigational Site 84041

Sagamihara, , Japan

Teva Investigational Site 84031

Tokyo, , Japan

Teva Investigational Site 84032

Tokyo, , Japan

Teva Investigational Site 84038

Toyama, , Japan

Teva Investigational Site 84046

Toyama, , Japan

Teva Investigational Site 84035

Toyoake-shi, , Japan

Teva Investigational Site 84040

Yokohama, , Japan

Teva Investigational Site 21084

Guadalajara, , Mexico

Teva Investigational Site 21085

Guadalajara, , Mexico

Teva Investigational Site 21088

Guadalajara, , Mexico

Teva Investigational Site 21089

Guadalajara, , Mexico

Teva Investigational Site 21087

Monterrey, , Mexico

Teva Investigational Site 21086

Zapopan, , Mexico

Teva Investigational Site 79047

Auckland, , New Zealand

Teva Investigational Site 79046

Auckland, , New Zealand

Teva Investigational Site 53310

Bialystok, , Poland

Teva Investigational Site 53315

Bialystok, , Poland

Teva Investigational Site 53308

Gdansk, , Poland

Teva Investigational Site 53311

Krakow, , Poland

Teva Investigational Site 53314

Lodz, , Poland

Teva Investigational Site 53312

Lodz, , Poland

Teva Investigational Site 53313

Poznan, , Poland

Teva Investigational Site 53309

Tarnów, , Poland

Teva Investigational Site 52108

Brasov, , Romania

Teva Investigational Site 52109

Brasov, , Romania

Teva Investigational Site 52107

Bucharest, , Romania

Teva Investigational Site 52105

Bucharest, , Romania

Teva Investigational Site 52104

Cluj-Napoca, , Romania

Teva Investigational Site 52111

Deva, , Romania

Teva Investigational Site 52106

Târgu Mureş, , Romania

Teva Investigational Site 52110

Timișoara, , Romania

Teva Investigational Site 50350

Barnaul, , Russia

Teva Investigational Site 50354

Kemerovo, , Russia

Teva Investigational Site 50348

Moscow, , Russia

Teva Investigational Site 50351

Moscow, , Russia

Teva Investigational Site 50347

Novosibirsk, , Russia

Teva Investigational Site 50355

Saint Petersburg, , Russia

Teva Investigational Site 50352

Saint Petersburg, , Russia

Teva Investigational Site 50349

Tomsk, , Russia

Teva Investigational Site 90027

Benoni, , South Africa

Teva Investigational Site 90028

Bloemfontein, , South Africa

Teva Investigational Site 90026

Cape Town, , South Africa

Teva Investigational Site 90031

Cape Town, , South Africa

Teva Investigational Site 90029

Cape Town, , South Africa

Teva Investigational Site 90032

Durban, , South Africa

Teva Investigational Site 90030

Durban, , South Africa

Teva Investigational Site 87015

Bucheon-si, , South Korea

Teva Investigational Site 87016

Seoul, , South Korea

Teva Investigational Site 87014

Seoul, , South Korea

Teva Investigational Site 31149

Barcelona, , Spain

Teva Investigational Site 31147

Esplugues de Llobregat, , Spain

Teva Investigational Site 31152

Girona, , Spain

Teva Investigational Site 31154

Vitoria-Gasteiz, , Spain

Teva Investigational Site 82042

Ankara, , Turkey (Türkiye)

Teva Investigational Site 82041

Izmir, , Turkey (Türkiye)

Teva Investigational Site 82040

Kocaeli, , Turkey (Türkiye)

Teva Investigational Site 82039

Konya, , Turkey (Türkiye)

Teva Investigational Site 82043

Mersin, , Turkey (Türkiye)

Teva Investigational Site 58216

Chernivtsi, , Ukraine

Teva Investigational Site 58219

Dnipropetrovsk, , Ukraine

Teva Investigational Site 58225

Dnipropetrovsk, , Ukraine

Teva Investigational Site 58222

Ivano-Frankivsk, , Ukraine

Teva Investigational Site 58227

Kharkiv, , Ukraine

Teva Investigational Site 58213

Kharkiv, , Ukraine

Teva Investigational Site 58221

Kharkiv, , Ukraine

Teva Investigational Site 58223

Kharkiv, , Ukraine

Teva Investigational Site 58214

Kremenchuk, , Ukraine

Teva Investigational Site 58228

Kryvyi Rih, , Ukraine

Teva Investigational Site 58220

Kyiv, , Ukraine

Teva Investigational Site 58230

Kyiv, , Ukraine

Teva Investigational Site 58218

Kyiv, , Ukraine

Teva Investigational Site 58226

Kyiv, , Ukraine

Teva Investigational Site 58253

Kyiv, , Ukraine

Teva Investigational Site 58234

Sumy, , Ukraine

Teva Investigational Site 58229

Vinnytsia, , Ukraine

Teva Investigational Site 58233

Vinnytsia, , Ukraine

Teva Investigational Site 58231

Zaporizhzhya, , Ukraine

Teva Investigational Site 58224

Zhaporizhzhya, , Ukraine

Countries

Brazil; Colombia; United States; Argentina; Australia; Belgium; Canada; Czechia; France; Germany; Hungary; Israel; Japan; Mexico; New Zealand; Poland; Romania; Russia; South Africa; South Korea; Spain; Turkey (Türkiye); Ukraine

References

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.

Reference Type: DERIVED

PMID: 32066536 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-000865-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C38072-AS-30025

Identifier Type: -

Identifier Source: org_study_id