An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

NCT02501629 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: C38072-AS-300272015-001580-39
• Study Type: interventional
• Target: 177
• Locations: 17 countries
• Sites: 127

Brief Summary

The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

Conditions

Asthma; Elevated Blood Eosinophils; Oral Corticosteroid Dependence

Keywords

Asthma; Elevated Blood Eosinophils; Oral corticosteroid dependence; Reslizumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline

  The primary endpoint was the 5-level categorized percent reduction in OCS dose during weeks 20 to 24 compared with the optimized dose at baseline. The primary analysis incorporated data from all randomized patients. Analysis of the primary and secondary variables related to categorical OCS dose reduction incorporated missing data as non-responders. No decrease indicates there was no decrease in OCS, loss of baseline asthma control during weeks 20 to 24, or discontinuation from study drug.

  Baseline (Day 1), Weeks 20-24

Secondary Outcomes (8)

• Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

  Baseline (Day 1), Weeks 20-24

• Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control

  Weeks 20-24

• Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures

  Baseline (Day 1), Weeks 20-24

• Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

  Baseline (Day 1), Weeks 20-24

• Annualized Rate of Clinical Asthma Exacerbations (CAEs)

  Day 1 through Week 24

Study Arms (2)

Reslizumab 110 mg

EXPERIMENTAL

Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.

Drug: Reslizumab; Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication; Drug: Oral Corticosteroid (OCS)

Placebo

PLACEBO COMPARATOR

Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.

Drug: Placebo; Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication; Drug: Oral Corticosteroid (OCS)

Interventions

Reslizumab DRUG

Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

Also known as: CEP38072

Reslizumab 110 mg

Placebo DRUG

Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

Placebo

Non-Oral Corticosteroid (non-OCS) Asthma Medication DRUG

Participants continue using their non-OCS background asthma medications without change during the study's treatment period.

Placebo; Reslizumab 110 mg

Oral Corticosteroid (OCS) DRUG

After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.

Placebo; Reslizumab 110 mg

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:

• The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
• Written informed consent is obtained.
• The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
• The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
• The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
• The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
• Other criteria may apply, please contact the investigator for more information.

You may not qualify if:

• The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
• The patient has another confounding underlying lung disorder.
• The patient has a known hypereosinophilic syndrome.
• The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
• The patient is pregnant or intends to become pregnant during the study or is lactating.
• The patient required treatment for an asthma exacerbation within 4 weeks of screening.
• The patient is a current smoker or has a smoking history ≥10 pack-years.
• The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
• The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
• The patient was previously exposed to benralizumab within 12 months of screening.
• The patient was previously exposed to reslizumab.
• The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
• The patient has current suspected drug and/or alcohol abuse.
• The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
• The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (127)

Teva Investigational Site 13357

Bakersfield, California, 93301, United States

Location

Teva Investigational Site 13365

Long Beach, California, 90813, United States

Location

Teva Investigational Site 13371

Clermont, Florida, 73034, United States

Location

Teva Investigational Site 13351

Homestead, Florida, 33030, United States

Location

Teva Investigational Site 13342

Kissimmee, Florida, 34741, United States

Location

Teva Investigational Site 13344

Miami, Florida, 33015, United States

Location

Teva Investigational Site 13372

Miami, Florida, 33133, United States

Location

Teva Investigational Site 13354

Pembroke Pines, Florida, 33029, United States

Location

Teva Investigational Site 13343

Saint Cloud, Florida, 34769, United States

Location

Teva Investigational Site 13368

Sebring, Florida, 33870, United States

Location

Teva Investigational Site 13346

Tampa, Florida, 33607, United States

Location

Teva Investigational Site 13367

Chicago, Illinois, 60612, United States

Location

Teva Investigational Site 13363

Normal, Illinois, 61761, United States

Location

Teva Investigational Site 13345

Michigan City, Indiana, 46360, United States

Location

Teva Investigational Site 13348

Lenexa, Kansas, 66215, United States

Location

Teva Investigational Site 13362

Biloxi, Mississippi, 39531, United States

Location

Teva Investigational Site 13350

St Louis, Missouri, 63106, United States

Location

Teva Investigational Site 13352

St Louis, Missouri, 63143, United States

Location

Teva Investigational Site 13356

New York, New York, 10016-9196, United States

Location

Teva Investigational Site 13349

Cincinnati, Ohio, 45231, United States

Location

Teva Investigational Site 13370

Edmond, Oklahoma, 73034, United States

Location

Teva Investigational Site 13347

Oklahoma City, Oklahoma, 73112, United States

Location

Teva Investigational Site 13366

Charleston, South Carolina, 29414, United States

Location

Teva Investigational Site 13377

Dallas, Texas, 75225, United States

Location

Teva Investigational Site 13369

Houston, Texas, 77099, United States

Location

Teva Investigational Site 13358

Fairfax, Virginia, 22030, United States

Location

Teva Investigational Site 20059

Buenos Aires, C1028AAP, Argentina

Location

Teva Investigational Site 20058

Buenos Aires, C1425BEN, Argentina

Location

Teva Investigational Site 20056

Buenos Aires, C1426ABP, Argentina

Location

Teva Investigational Site 20057

Buenos Aires, Argentina

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Teva Investigational Site 20052

Córdoba, X5003DCE, Argentina

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Teva Investigational Site 20055

Mendoza, 5500, Argentina

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Teva Investigational Site 20050

Mendoza, M5500CCG, Argentina

Location

Teva Investigational Site 20087

Rosario, 2000, Argentina

Location

Teva Investigational Site 20051

San Miguel de Tucumán, T4000CHE, Argentina

Location

Teva Investigational Site 20066

San Rafael, Argentina

Location

Teva Investigational Site 78089

Bedford Park, 5042, Australia

Location

Teva Investigational Site 78092

Box Hill, 3128, Australia

Location

Teva Investigational Site 78097

Frankston, 3199, Australia

Location

Teva Investigational Site 78093

Kent Town, 5067, Australia

Location

Teva Investigational Site 78090

Nedlands, 6009, Australia

Location

Teva Investigational Site 78091

New Lambton, 2305, Australia

Location

Teva Investigational Site 37059

Brussels, 1200, Belgium

Location

Teva Investigational Site 37058

Gembloux, 5030, Belgium

Location

Teva Investigational Site 54133

Břeclav, 690 74, Czechia

Location

Teva Investigational Site 54132

Jindřichův Hradec, 377 38, Czechia

Location

Teva Investigational Site 35186

Le Kremlin-Bicêtre, 94275 Cedex, France

Location

Teva Investigational Site 35185

Lille, 59037, France

Location

Teva Investigational Site 35189

Lyon, 69317, France

Location

Teva Investigational Site 35187

Strasbourg, 67091, France

Location

Teva Investigational Site 32621

Bad Wörishofen, 86825, Germany

Location

Teva Investigational Site 32576

Berlin, 10717, Germany

Location

Teva Investigational Site 32573

Berlin, 12159, Germany

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Teva Investigational Site 32578

Berlin, 13187, Germany

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Teva Investigational Site 32622

Frankfurt, 60389, Germany

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Teva Investigational Site 32579

Hanover, 30173, Germany

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Teva Investigational Site 32574

Leipzig, 4275, Germany

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Teva Investigational Site 32580

Rostock, 18057, Germany

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Teva Investigational Site 51254

Csorna, 9300, Hungary

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Teva Investigational Site 51232

Dombóvár, 7200, Hungary

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Teva Investigational Site 51233

Hatvan, 3000, Hungary

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Teva Investigational Site 51253

Szombathely, 9700, Hungary

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Teva Investigational Site 80085

Haifa, 3436212, Israel

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Teva Investigational Site 80083

Jerusalem, 91120, Israel

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Teva Investigational Site 80091

Kfar Saba, 44281, Israel

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Teva Investigational Site 80084

Petah Tikva, 49100, Israel

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Teva Investigational Site 80082

Rehovot, 76100, Israel

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Teva Investigational Site 30152

Catanzaro, 88100, Italy

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Teva Investigational Site 30154

Genova, 16132, Italy

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Teva Investigational Site 21106

Chihuahua City, 31203, Mexico

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Teva Investigational Site 21102

Distrito Federal, 07020, Mexico

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Teva Investigational Site 21104

Durango, 34080, Mexico

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Teva Investigational Site 21094

Guadalajara, 44100, Mexico

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Teva Investigational Site 21091

Guadalajara, 44130, Mexico

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Teva Investigational Site 21100

Guadalajara, 44160, Mexico

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Teva Investigational Site 21093

Guadalajara, 44220, Mexico

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Teva Investigational Site 21090

Mexico City, 06700, Mexico

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Teva Investigational Site 21103

Monterrey, 64460, Mexico

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Teva Investigational Site 21101

Monterrey, 64718, Mexico

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Teva Investigational Site 21105

Querétaro, 76800, Mexico

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Teva Investigational Site 38084

Leeuwarden, 8901 BR, Netherlands

Location

Teva Investigational Site 38085

Zwolle, 8025-AB, Netherlands

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Teva Investigational Site 53316

Gdansk, 80-952, Poland

Location

Teva Investigational Site 53318

Krakow, 31-624, Poland

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Teva Investigational Site 53319

Lodz, 90-153, Poland

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Teva Investigational Site 53321

Lodz, 90-153, Poland

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Teva Investigational Site 53322

Lubin, 59-300, Poland

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Teva Investigational Site 53320

Ostrów Wielkopolski, 63-400, Poland

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Teva Investigational Site 53358

Rzeszów, 35-612, Poland

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Teva Investigational Site 53317

Tarnów, 33-100, Poland

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Teva Investigational Site 53323

Wroclaw, 54-239, Poland

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Teva Investigational Site 50356

Barnaul, 656024, Russia

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Teva Investigational Site 50417

Chelyabinsk, 454021, Russia

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Teva Investigational Site 50385

Kemerovo, 650002, Russia

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Teva Investigational Site 50382

Kemerovo, 650099, Russia

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Teva Investigational Site 50384

Moscow, 129090, Russia

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Teva Investigational Site 50383

Novosibirsk, 630091, Russia

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Teva Investigational Site 50386

Novosibirsk, 630099, Russia

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Teva Investigational Site 50357

Saint Petersburg, 197089, Russia

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Teva Investigational Site 50418

Tomsk, 634050, Russia

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Teva Investigational Site 50358

Tomsk, 634063, Russia

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Teva Investigational Site 50419

Yekaterinburg, 620039, Russia

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Teva Investigational Site 87020

Goyang-si, 411-706, South Korea

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Teva Investigational Site 87024

Jeonju, 561-712, South Korea

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Teva Investigational Site 87025

Seongnam-si, 463-707, South Korea

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Teva Investigational Site 87023

Seoul, 137-701, South Korea

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Teva Investigational Site 87022

Seoul, 138-736, South Korea

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Teva Investigational Site 87021

Seoul, 143-729, South Korea

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Teva Investigational Site 31159

Barcelona, ?08025, Spain

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Teva Investigational Site 31161

Girona, 17004, Spain

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Teva Investigational Site 31160

Valencia, 46017, Spain

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Teva Investigational Site 31158

Valencia, 46026, Spain

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Teva Investigational Site 58245

Dnipro, 49044, Ukraine

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Teva Investigational Site 58238

Dnipropetrovsk, 49074, Ukraine

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Teva Investigational Site 58240

Ivano-Frankivsk, 76018, Ukraine

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Teva Investigational Site 58244

Kharkiv, 61002, Ukraine

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Teva Investigational Site 58235

Kharkiv, 61007, Ukraine

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Teva Investigational Site 58239

Kharkiv, 61035, Ukraine

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Teva Investigational Site 58241

Kharkiv, 61039, Ukraine

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Teva Investigational Site 58249

Kremenchuk, 39617, Ukraine

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Teva Investigational Site 58248

Kyiv, 03680, Ukraine

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Teva Investigational Site 58251

Kyiv, 2091, Ukraine

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Teva Investigational Site 58237

Kyiv, 3049, Ukraine

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Teva Investigational Site 58250

Kyiv, ?03680, Ukraine

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Teva Investigational Site 58243

Sumy, 40022, Ukraine

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Teva Investigational Site 58246

Vinnytsia, 21001, Ukraine

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Teva Investigational Site 58242

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; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

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

USMedInfo@tevapharm.com

1-888-483-8279

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: July 14, 2015
• First Posted: July 17, 2015
• Study Start: September 29, 2015
• Primary Completion: June 19, 2017
• Study Completion: December 4, 2017
• Last Updated: November 9, 2021
• Results First Posted: September 13, 2018

Record last verified: 2021-11

Locations

US (26); AR (10); HU (4); DE (8); CZ (2); IL (5); KR (6); UA (15); BE (2); RU (11); ES (4); FR (4); PL (9); IT (2); AU (6); ME (11); NL (2)