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A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

NCT ID: NCT03052725

Last Updated: 2022-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-02-22

Brief Summary

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This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.

Detailed Description

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Conditions

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Eosinophils, Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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reslizumab 110 mg

Reslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.

Group Type EXPERIMENTAL

reslizumab

Intervention Type DRUG

Reslizumab was provided in a pre-filled syringe.

Interventions

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reslizumab

Reslizumab was provided in a pre-filled syringe.

Intervention Type DRUG

Other Intervention Names

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CEP38072

Eligibility Criteria

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Inclusion Criteria

• Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)

\~\~ Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

* Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-30027.
* The patient has any clinically significant, uncontrolled medical condition
* The patient has another confounding underlying lung disorder
* The patient has a known/diagnosed hypereosinophilic syndrome.
* The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
* The patient is a pregnant or lactating woman
* The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.
* The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS
* The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
* The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

* Additional criteria 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 14647

Birmingham, Alabama, United States

Site Status

Teva Investigational Site 14631

Bakersfield, California, United States

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Teva Investigational Site 14648

Huntington Beach, California, United States

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Teva Investigational Site 14637

Napa, California, United States

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Teva Investigational Site 14654

Stockton, California, United States

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Teva Investigational Site 14636

Walnut Creek, California, United States

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Teva Investigational Site 14626

Aventura, Florida, United States

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Teva Investigational Site 14634

Homestead, Florida, United States

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Teva Investigational Site 14650

Miami, Florida, United States

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Teva Investigational Site 14629

Miami, Florida, United States

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Teva Investigational Site 14619

Miami, Florida, United States

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Teva Investigational Site 14624

Orlando, Florida, United States

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Teva Investigational Site 14638

Tallahassee, Florida, United States

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Teva Investigational Site 14642

Buford, Georgia, United States

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Teva Investigational Site 14651

Chicago, Illinois, United States

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Teva Investigational Site 14645

Michigan City, Indiana, United States

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Teva Investigational Site 14620

Owensboro, Kentucky, United States

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Teva Investigational Site 14623

Lafayette, Louisiana, United States

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Teva Investigational Site 14627

North Dartmouth, Massachusetts, United States

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Teva Investigational Site 14644

Boys Town, Nebraska, United States

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Teva Investigational Site 14652

Ocean City, New Jersey, United States

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Teva Investigational Site 14632

Lake Success, New York, United States

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Teva Investigational Site 14646

New York, New York, United States

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Teva Investigational Site 14633

Cincinnati, Ohio, United States

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Teva Investigational Site 14653

Cleveland, Ohio, United States

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Teva Investigational Site 14621

Edmond, Oklahoma, United States

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Teva Investigational Site 14625

Edmond, Oklahoma, United States

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Teva Investigational Site 14643

Jenkintown, Pennsylvania, United States

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Teva Investigational Site 14622

Pittsburgh, Pennsylvania, United States

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Teva Investigational Site 14630

East Providence, Rhode Island, United States

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Teva Investigational Site 14649

Providence, Rhode Island, United States

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Teva Investigational Site 14655

Knoxville, Tennessee, United States

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Teva Investigational Site 14639

Corsicana, Texas, United States

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Teva Investigational Site 14640

Dallas, Texas, United States

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Teva Investigational Site 14641

Provo, Utah, United States

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Teva Investigational Site 14628

Abingdon, Virginia, United States

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Teva Investigational Site 14635

Falls Church, Virginia, United States

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Teva Investigational Site 37082

Brussels, , Belgium

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Teva Investigational Site 37081

Erpent, , Belgium

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Teva Investigational Site 37083

Ghent, , Belgium

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Teva Investigational Site 11133

Vancouver, British Columbia, Canada

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Teva Investigational Site 11134

Etobicoke, Ontario, Canada

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Teva Investigational Site 54151

Břeclav, , Czechia

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Teva Investigational Site 54150

Jablonec nad Nisou, , Czechia

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Teva Investigational Site 54148

Jindřichův Hradec, , Czechia

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Teva Investigational Site 54149

Tábor, , Czechia

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Teva Investigational Site 35229

Le Kremlin-Bicêtre, , France

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Teva Investigational Site 35227

Strasbourg, , France

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Teva Investigational Site 35228

Toulouse, , France

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Teva Investigational Site 32670

Berlin, , Germany

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Teva Investigational Site 32680

Berlin, , Germany

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Teva Investigational Site 32673

Berlin, , Germany

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Teva Investigational Site 32679

Frankfurt, , Germany

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Teva Investigational Site 32675

Frankfurt am Main, , Germany

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Teva Investigational Site 32678

Hamburg, , Germany

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Teva Investigational Site 32681

Hanover, , Germany

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Teva Investigational Site 32677

Koblenz, , Germany

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Teva Investigational Site 32672

Leipzig, , Germany

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Teva Investigational Site 32671

Leipzig, , Germany

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Teva Investigational Site 32674

Lübeck, , Germany

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Teva Investigational Site 32682

Rostock, , Germany

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Teva Investigational Site 32676

Tempelhof, , Germany

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Teva Investigational Site 51291

Balassagyarmat, , Hungary

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Teva Investigational Site 51290

Budapest, , Hungary

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Teva Investigational Site 51293

Csorna, , Hungary

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Teva Investigational Site 51292

Debrecen, , Hungary

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Teva Investigational Site 51283

Debrecen, , Hungary

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Teva Investigational Site 51286

Gödöllő, , Hungary

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Teva Investigational Site 51284

Győr, , Hungary

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Teva Investigational Site 51285

Hajdúnánás, , Hungary

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Teva Investigational Site 51282

Kapuvár, , Hungary

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Teva Investigational Site 51288

Szeged, , Hungary

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Teva Investigational Site 51289

Szigetvár, , Hungary

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Teva Investigational Site 51280

Szombathely, , Hungary

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Teva Investigational Site 51281

Tatabánya, , Hungary

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Teva Investigational Site 51287

Veszprém, , Hungary

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Teva Investigational Site 80136

Ashkelon, , Israel

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Teva Investigational Site 80129

Haifa, , Israel

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Teva Investigational Site 80131

Jerusalem, , Israel

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Teva Investigational Site 80135

Jerusalem, , Israel

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Teva Investigational Site 80134

Kfar Saba, , Israel

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Teva Investigational Site 80132

Petah Tikva, , Israel

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Teva Investigational Site 80133

Ramat Gan, , Israel

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Teva Investigational Site 80130

Rehovot, , Israel

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Teva Investigational Site 53405

Bialystok, , Poland

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Teva Investigational Site 53402

Gdansk, , Poland

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Teva Investigational Site 53399

Krakow, , Poland

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Teva Investigational Site 53408

Lodz, , Poland

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Teva Investigational Site 53400

Lodz, , Poland

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Teva Investigational Site 53403

Lubin, , Poland

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Teva Investigational Site 53407

Ostrów Wielkopolski, , Poland

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Teva Investigational Site 53401

Poznan, , Poland

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Teva Investigational Site 53404

Tarnów, , Poland

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Teva Investigational Site 53406

Wroclaw, , Poland

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Teva Investigational Site 52115

Brasov, , Romania

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Teva Investigational Site 52116

Brasov, , Romania

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Teva Investigational Site 52113

Cluj-Napoca, , Romania

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Teva Investigational Site 52114

Târgu Mureş, , Romania

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Teva Investigational Site 52117

Timișoara, , Romania

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Teva Investigational Site 50460

Barnaul, , Russia

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Teva Investigational Site 50453

Kemerovo, , Russia

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Teva Investigational Site 50461

Kemerovo, , Russia

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Teva Investigational Site 50456

Moscow, , Russia

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Teva Investigational Site 50459

Moscow, , Russia

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Teva Investigational Site 50455

Novosibirsk, , Russia

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Teva Investigational Site 50454

Saint Petersburg, , Russia

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Teva Investigational Site 50457

Saint Petersburg, , Russia

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Teva Investigational Site 50458

Tomsk, , Russia

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Teva Investigational Site 31219

Barcelona, , Spain

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Teva Investigational Site 31218

Valencia, , Spain

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Teva Investigational Site 31217

Valencia, , Spain

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Teva Investigational Site 58283

Chernivtsi, , Ukraine

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Teva Investigational Site 58304

Dnipropetrovsk, , Ukraine

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Teva Investigational Site 58287

Dnipropetrovsk, , Ukraine

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Teva Investigational Site 58295

Ivano-Frankivsk, , Ukraine

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Teva Investigational Site 58293

Kharkiv, , Ukraine

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Teva Investigational Site 58289

Kharkiv, , Ukraine

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Teva Investigational Site 58284

Kharkiv, , Ukraine

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Teva Investigational Site 58288

Kharkiv, , Ukraine

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Teva Investigational Site 58302

Kremenchuk, , Ukraine

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Teva Investigational Site 58292

Kryvyi Rih, , Ukraine

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Teva Investigational Site 58303

Kyiv, , Ukraine

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Teva Investigational Site 58282

Kyiv, , Ukraine

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Teva Investigational Site 58285

Kyiv, , Ukraine

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Teva Investigational Site 58286

Kyiv, , Ukraine

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Teva Investigational Site 58290

Kyiv, , Ukraine

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Teva Investigational Site 58291

Kyiv, , Ukraine

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Teva Investigational Site 58296

Kyiv, , Ukraine

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Teva Investigational Site 58299

Kyiv, , Ukraine

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Teva Investigational Site 58297

Sumy, , Ukraine

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Teva Investigational Site 58294

Vinnytsia, , Ukraine

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Teva Investigational Site 58301

Vinnytsia, , Ukraine

Site Status

Teva Investigational Site 58298

Zaporizhzhya, , Ukraine

Site Status

Teva Investigational Site 58300

Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Belgium Canada Czechia France Germany Hungary Israel Poland Romania Russia Spain Ukraine

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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2016-004661-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C38072-AS-30066

Identifier Type: -

Identifier Source: org_study_id