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

NCT ID: NCT02501629

Last Updated: 2021-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-29

Study Completion Date

2017-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Elevated Blood Eosinophils Oral Corticosteroid Dependence

Keywords

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Asthma Elevated Blood Eosinophils Oral corticosteroid dependence Reslizumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Reslizumab 110 mg

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.

Group Type EXPERIMENTAL

Reslizumab

Intervention Type 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.

Non-Oral Corticosteroid (non-OCS) Asthma Medication

Intervention Type DRUG

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

Oral Corticosteroid (OCS)

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Non-Oral Corticosteroid (non-OCS) Asthma Medication

Intervention Type DRUG

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

Oral Corticosteroid (OCS)

Intervention Type DRUG

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

Interventions

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Reslizumab

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Non-Oral Corticosteroid (non-OCS) Asthma Medication

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

Intervention Type DRUG

Oral Corticosteroid (OCS)

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

Intervention Type DRUG

Other Intervention Names

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CEP38072

Eligibility Criteria

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Inclusion Criteria

1. The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
2. Written informed consent is obtained.
3. 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.
4. The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
5. The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
6. 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.

Exclusion Criteria

1. 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.
2. The patient has another confounding underlying lung disorder.
3. The patient has a known hypereosinophilic syndrome.
4. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
5. The patient is pregnant or intends to become pregnant during the study or is lactating.
6. The patient required treatment for an asthma exacerbation within 4 weeks of screening.
7. The patient is a current smoker or has a smoking history ≥10 pack-years.
8. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
9. The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
10. The patient was previously exposed to benralizumab within 12 months of screening.
11. The patient was previously exposed to reslizumab.
12. The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
13. The patient has current suspected drug and/or alcohol abuse.
14. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
15. The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.

* Other criteria may apply, please contact the investigator for more information.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 13357

Bakersfield, California, United States

Site Status

Teva Investigational Site 13365

Long Beach, California, United States

Site Status

Teva Investigational Site 13371

Clermont, Florida, United States

Site Status

Teva Investigational Site 13351

Homestead, Florida, United States

Site Status

Teva Investigational Site 13342

Kissimmee, Florida, United States

Site Status

Teva Investigational Site 13344

Miami, Florida, United States

Site Status

Teva Investigational Site 13372

Miami, Florida, United States

Site Status

Teva Investigational Site 13354

Pembroke Pines, Florida, United States

Site Status

Teva Investigational Site 13343

Saint Cloud, Florida, United States

Site Status

Teva Investigational Site 13368

Sebring, Florida, United States

Site Status

Teva Investigational Site 13346

Tampa, Florida, United States

Site Status

Teva Investigational Site 13367

Chicago, Illinois, United States

Site Status

Teva Investigational Site 13363

Normal, Illinois, United States

Site Status

Teva Investigational Site 13345

Michigan City, Indiana, United States

Site Status

Teva Investigational Site 13348

Lenexa, Kansas, United States

Site Status

Teva Investigational Site 13362

Biloxi, Mississippi, United States

Site Status

Teva Investigational Site 13350

St Louis, Missouri, United States

Site Status

Teva Investigational Site 13352

St Louis, Missouri, United States

Site Status

Teva Investigational Site 13356

New York, New York, United States

Site Status

Teva Investigational Site 13349

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 13370

Edmond, Oklahoma, United States

Site Status

Teva Investigational Site 13347

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 13366

Charleston, South Carolina, United States

Site Status

Teva Investigational Site 13377

Dallas, Texas, United States

Site Status

Teva Investigational Site 13369

Houston, Texas, United States

Site Status

Teva Investigational Site 13358

Fairfax, Virginia, United States

Site Status

Teva Investigational Site 20059

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 20058

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 20056

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 20057

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 20052

Córdoba, , Argentina

Site Status

Teva Investigational Site 20055

Mendoza, , Argentina

Site Status

Teva Investigational Site 20050

Mendoza, , Argentina

Site Status

Teva Investigational Site 20087

Rosario, , Argentina

Site Status

Teva Investigational Site 20051

San Miguel de Tucumán, , Argentina

Site Status

Teva Investigational Site 20066

San Rafael, , Argentina

Site Status

Teva Investigational Site 78089

Bedford Park, , Australia

Site Status

Teva Investigational Site 78092

Box Hill, , Australia

Site Status

Teva Investigational Site 78097

Frankston, , Australia

Site Status

Teva Investigational Site 78093

Kent Town, , Australia

Site Status

Teva Investigational Site 78090

Nedlands, , Australia

Site Status

Teva Investigational Site 78091

New Lambton, , Australia

Site Status

Teva Investigational Site 37059

Brussels, , Belgium

Site Status

Teva Investigational Site 37058

Gembloux, , Belgium

Site Status

Teva Investigational Site 54133

Břeclav, , Czechia

Site Status

Teva Investigational Site 54132

Jindřichův Hradec, , Czechia

Site Status

Teva Investigational Site 35186

Le Kremlin-Bicêtre, , France

Site Status

Teva Investigational Site 35185

Lille, , France

Site Status

Teva Investigational Site 35189

Lyon, , France

Site Status

Teva Investigational Site 35187

Strasbourg, , France

Site Status

Teva Investigational Site 32621

Bad Wörishofen, , Germany

Site Status

Teva Investigational Site 32576

Berlin, , Germany

Site Status

Teva Investigational Site 32573

Berlin, , Germany

Site Status

Teva Investigational Site 32578

Berlin, , Germany

Site Status

Teva Investigational Site 32622

Frankfurt, , Germany

Site Status

Teva Investigational Site 32579

Hanover, , Germany

Site Status

Teva Investigational Site 32574

Leipzig, , Germany

Site Status

Teva Investigational Site 32580

Rostock, , Germany

Site Status

Teva Investigational Site 51254

Csorna, , Hungary

Site Status

Teva Investigational Site 51232

Dombóvár, , Hungary

Site Status

Teva Investigational Site 51233

Hatvan, , Hungary

Site Status

Teva Investigational Site 51253

Szombathely, , Hungary

Site Status

Teva Investigational Site 80085

Haifa, , Israel

Site Status

Teva Investigational Site 80083

Jerusalem, , Israel

Site Status

Teva Investigational Site 80091

Kfar Saba, , Israel

Site Status

Teva Investigational Site 80084

Petah Tikva, , Israel

Site Status

Teva Investigational Site 80082

Rehovot, , Israel

Site Status

Teva Investigational Site 30152

Catanzaro, , Italy

Site Status

Teva Investigational Site 30154

Genova, , Italy

Site Status

Teva Investigational Site 21106

Chihuahua City, , Mexico

Site Status

Teva Investigational Site 21102

Distrito Federal, , Mexico

Site Status

Teva Investigational Site 21104

Durango, , Mexico

Site Status

Teva Investigational Site 21094

Guadalajara, , Mexico

Site Status

Teva Investigational Site 21091

Guadalajara, , Mexico

Site Status

Teva Investigational Site 21100

Guadalajara, , Mexico

Site Status

Teva Investigational Site 21093

Guadalajara, , Mexico

Site Status

Teva Investigational Site 21090

Mexico City, , Mexico

Site Status

Teva Investigational Site 21103

Monterrey, , Mexico

Site Status

Teva Investigational Site 21101

Monterrey, , Mexico

Site Status

Teva Investigational Site 21105

Querétaro, , Mexico

Site Status

Teva Investigational Site 38084

Leeuwarden, , Netherlands

Site Status

Teva Investigational Site 38085

Zwolle, , Netherlands

Site Status

Teva Investigational Site 53316

Gdansk, , Poland

Site Status

Teva Investigational Site 53318

Krakow, , Poland

Site Status

Teva Investigational Site 53319

Lodz, , Poland

Site Status

Teva Investigational Site 53321

Lodz, , Poland

Site Status

Teva Investigational Site 53322

Lubin, , Poland

Site Status

Teva Investigational Site 53320

Ostrów Wielkopolski, , Poland

Site Status

Teva Investigational Site 53358

Rzeszów, , Poland

Site Status

Teva Investigational Site 53317

Tarnów, , Poland

Site Status

Teva Investigational Site 53323

Wroclaw, , Poland

Site Status

Teva Investigational Site 50356

Barnaul, , Russia

Site Status

Teva Investigational Site 50417

Chelyabinsk, , Russia

Site Status

Teva Investigational Site 50385

Kemerovo, , Russia

Site Status

Teva Investigational Site 50382

Kemerovo, , Russia

Site Status

Teva Investigational Site 50384

Moscow, , Russia

Site Status

Teva Investigational Site 50383

Novosibirsk, , Russia

Site Status

Teva Investigational Site 50386

Novosibirsk, , Russia

Site Status

Teva Investigational Site 50357

Saint Petersburg, , Russia

Site Status

Teva Investigational Site 50418

Tomsk, , Russia

Site Status

Teva Investigational Site 50358

Tomsk, , Russia

Site Status

Teva Investigational Site 50419

Yekaterinburg, , Russia

Site Status

Teva Investigational Site 87020

Goyang-si, , South Korea

Site Status

Teva Investigational Site 87024

Jeonju, , South Korea

Site Status

Teva Investigational Site 87025

Seongnam-si, , South Korea

Site Status

Teva Investigational Site 87023

Seoul, , South Korea

Site Status

Teva Investigational Site 87022

Seoul, , South Korea

Site Status

Teva Investigational Site 87021

Seoul, , South Korea

Site Status

Teva Investigational Site 31159

Barcelona, , Spain

Site Status

Teva Investigational Site 31161

Girona, , Spain

Site Status

Teva Investigational Site 31160

Valencia, , Spain

Site Status

Teva Investigational Site 31158

Valencia, , Spain

Site Status

Teva Investigational Site 58245

Dnipro, , Ukraine

Site Status

Teva Investigational Site 58238

Dnipropetrovsk, , Ukraine

Site Status

Teva Investigational Site 58240

Ivano-Frankivsk, , Ukraine

Site Status

Teva Investigational Site 58244

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 58235

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 58239

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 58241

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 58249

Kremenchuk, , Ukraine

Site Status

Teva Investigational Site 58248

Kyiv, , Ukraine

Site Status

Teva Investigational Site 58251

Kyiv, , Ukraine

Site Status

Teva Investigational Site 58237

Kyiv, , Ukraine

Site Status

Teva Investigational Site 58250

Kyiv, , Ukraine

Site Status

Teva Investigational Site 58243

Sumy, , Ukraine

Site Status

Teva Investigational Site 58246

Vinnytsia, , Ukraine

Site Status

Teva Investigational Site 58242

Zhaporizhzhya, , Ukraine

Site Status

Countries

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Bulgaria South Africa United States Argentina Australia Belgium Czechia France Germany Hungary Israel Italy Mexico Netherlands Poland Russia South Korea Spain Ukraine

References

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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

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-001580-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C38072-AS-30027

Identifier Type: -

Identifier Source: org_study_id