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

NCT03052725 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: C38072-AS-300662016-004661-23
• Study Type: interventional
• Target: 391
• Locations: 13 countries
• Sites: 134

Brief Summary

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.

Conditions

Eosinophils, Asthma

Outcome Measures

Primary Outcomes (1)

• Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

  Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

Secondary Outcomes (16)

• Participants With Potentially Clinically Significant Abnormal Hematology Values

  Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits

• Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values

  Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits

• Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity

  Weeks 4, 8, 12, 16, 20, 24, 28, and 36

• Participants With Potentially Clinically Significant Abnormal Vital Sign Values

  Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits

• Annualized Rate of Clinical Asthma Exacerbations (CAEs)

  Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

Study Arms (1)

reslizumab 110 mg

EXPERIMENTAL

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.

Drug: reslizumab

Interventions

reslizumab DRUG

Reslizumab was provided in a pre-filled syringe.

Also known as: CEP38072

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (134)

Teva Investigational Site 14647

Birmingham, Alabama, 35209, United States

Location

Teva Investigational Site 14631

Bakersfield, California, 93301, United States

Location

Teva Investigational Site 14648

Huntington Beach, California, 92647, United States

Location

Teva Investigational Site 14637

Napa, California, 94558, United States

Location

Teva Investigational Site 14654

Stockton, California, 95207, United States

Location

Teva Investigational Site 14636

Walnut Creek, California, 94598, United States

Location

Teva Investigational Site 14626

Aventura, Florida, 33180, United States

Location

Teva Investigational Site 14634

Homestead, Florida, 33030, United States

Location

Teva Investigational Site 14650

Miami, Florida, 33015, United States

Location

Teva Investigational Site 14629

Miami, Florida, 33173, United States

Location

Teva Investigational Site 14619

Miami, Florida, 33186, United States

Location

Teva Investigational Site 14624

Orlando, Florida, 32819, United States

Location

Teva Investigational Site 14638

Tallahassee, Florida, 32308, United States

Location

Teva Investigational Site 14642

Buford, Georgia, 30518, United States

Location

Teva Investigational Site 14651

Chicago, Illinois, 60612, United States

Location

Teva Investigational Site 14645

Michigan City, Indiana, 46360, United States

Location

Teva Investigational Site 14620

Owensboro, Kentucky, 42301, United States

Location

Teva Investigational Site 14623

Lafayette, Louisiana, 70508, United States

Location

Teva Investigational Site 14627

North Dartmouth, Massachusetts, 02747, United States

Location

Teva Investigational Site 14644

Boys Town, Nebraska, 68010, United States

Location

Teva Investigational Site 14652

Ocean City, New Jersey, 07712, United States

Location

Teva Investigational Site 14632

Lake Success, New York, 11042, United States

Location

Teva Investigational Site 14646

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

Location

Teva Investigational Site 14633

Cincinnati, Ohio, 45221, United States

Location

Teva Investigational Site 14653

Cleveland, Ohio, 44106, United States

Location

Teva Investigational Site 14621

Edmond, Oklahoma, 73034, United States

Location

Teva Investigational Site 14625

Edmond, Oklahoma, 73034, United States

Location

Teva Investigational Site 14643

Jenkintown, Pennsylvania, 19046, United States

Location

Teva Investigational Site 14622

Pittsburgh, Pennsylvania, 15241, United States

Location

Teva Investigational Site 14630

East Providence, Rhode Island, 02914, United States

Location

Teva Investigational Site 14649

Providence, Rhode Island, 02909, United States

Location

Teva Investigational Site 14655

Knoxville, Tennessee, 37919, United States

Location

Teva Investigational Site 14639

Corsicana, Texas, 75110, United States

Location

Teva Investigational Site 14640

Dallas, Texas, 75225, United States

Location

Teva Investigational Site 14641

Provo, Utah, 84604, United States

Location

Teva Investigational Site 14628

Abingdon, Virginia, 24210, United States

Location

Teva Investigational Site 14635

Falls Church, Virginia, 22044, United States

Location

Teva Investigational Site 37082

Brussels, 1200, Belgium

Location

Teva Investigational Site 37081

Erpent, 5101, Belgium

Location

Teva Investigational Site 37083

Ghent, 9000, Belgium

Location

Teva Investigational Site 11133

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Teva Investigational Site 11134

Etobicoke, Ontario, M9V 4B4, Canada

Location

Teva Investigational Site 54151

Břeclav, 690 74, Czechia

Location

Teva Investigational Site 54150

Jablonec nad Nisou, 46601, Czechia

Location

Teva Investigational Site 54148

Jindřichův Hradec, 377 38, Czechia

Location

Teva Investigational Site 54149

Tábor, 39001, Czechia

Location

Teva Investigational Site 35229

Le Kremlin-Bicêtre, 94275 Cedex, France

Location

Teva Investigational Site 35227

Strasbourg, 67091, France

Location

Teva Investigational Site 35228

Toulouse, 31059, France

Location

Teva Investigational Site 32670

Berlin, 10717, Germany

Location

Teva Investigational Site 32680

Berlin, 10969, Germany

Location

Teva Investigational Site 32673

Berlin, 14059, Germany

Location

Teva Investigational Site 32679

Frankfurt, 60596, Germany

Location

Teva Investigational Site 32675

Frankfurt am Main, 60389, Germany

Location

Teva Investigational Site 32678

Hamburg, 22299, Germany

Location

Teva Investigational Site 32681

Hanover, 30173, Germany

Location

Teva Investigational Site 32677

Koblenz, 56068, Germany

Location

Teva Investigational Site 32672

Leipzig, 4357, Germany

Location

Teva Investigational Site 32671

Leipzig, ?04275, Germany

Location

Teva Investigational Site 32674

Lübeck, 23552, Germany

Location

Teva Investigational Site 32682

Rostock, 18057, Germany

Location

Teva Investigational Site 32676

Tempelhof, 12099, Germany

Location

Teva Investigational Site 51291

Balassagyarmat, 2660, Hungary

Location

Teva Investigational Site 51290

Budapest, H-1036, Hungary

Location

Teva Investigational Site 51293

Csorna, 9300, Hungary

Location

Teva Investigational Site 51292

Debrecen, 4032, Hungary

Location

Teva Investigational Site 51283

Debrecen, 4043, Hungary

Location

Teva Investigational Site 51286

Gödöllő, 2100, Hungary

Location

Teva Investigational Site 51284

Győr, 9023, Hungary

Location

Teva Investigational Site 51285

Hajdúnánás, 4080, Hungary

Location

Teva Investigational Site 51282

Kapuvár, 9330, Hungary

Location

Teva Investigational Site 51288

Szeged, 6720, Hungary

Location

Teva Investigational Site 51289

Szigetvár, 7900, Hungary

Location

Teva Investigational Site 51280

Szombathely, 9700, Hungary

Location

Teva Investigational Site 51281

Tatabánya, 2800, Hungary

Location

Teva Investigational Site 51287

Veszprém, 8200, Hungary

Location

Teva Investigational Site 80136

Ashkelon, 7830604, Israel

Location

Teva Investigational Site 80129

Haifa, 3436212, Israel

Location

Teva Investigational Site 80131

Jerusalem, 91031, Israel

Location

Teva Investigational Site 80135

Jerusalem, 9112001, Israel

Location

Teva Investigational Site 80134

Kfar Saba, 4428164, Israel

Location

Teva Investigational Site 80132

Petah Tikva, 49100, Israel

Location

Teva Investigational Site 80133

Ramat Gan, 5262100, Israel

Location

Teva Investigational Site 80130

Rehovot, 76100, Israel

Location

Teva Investigational Site 53405

Bialystok, 15-044, Poland

Location

Teva Investigational Site 53402

Gdansk, 80-952, Poland

Location

Teva Investigational Site 53399

Krakow, 31-624, Poland

Location

Teva Investigational Site 53408

Lodz, 90-153, Poland

Location

Teva Investigational Site 53400

Lodz, 90-329, Poland

Location

Teva Investigational Site 53403

Lubin, 59-300, Poland

Location

Teva Investigational Site 53407

Ostrów Wielkopolski, 63-400, Poland

Location

Teva Investigational Site 53401

Poznan, 60-214, Poland

Location

Teva Investigational Site 53404

Tarnów, 33-100, Poland

Location

Teva Investigational Site 53406

Wroclaw, 54-239, Poland

Location

Teva Investigational Site 52115

Brasov, 500051, Romania

Location

Teva Investigational Site 52116

Brasov, 500086, Romania

Location

Teva Investigational Site 52113

Cluj-Napoca, 400371, Romania

Location

Teva Investigational Site 52114

Târgu Mureş, 540136, Romania

Location

Teva Investigational Site 52117

Timișoara, 300310, Romania

Location

Teva Investigational Site 50460

Barnaul, 656024, Russia

Location

Teva Investigational Site 50453

Kemerovo, 650002, Russia

Location

Teva Investigational Site 50461

Kemerovo, 650099, Russia

Location

Teva Investigational Site 50456

Moscow, 115478, Russia

Location

Teva Investigational Site 50459

Moscow, 119991, Russia

Location

Teva Investigational Site 50455

Novosibirsk, 630091, Russia

Location

Teva Investigational Site 50454

Saint Petersburg, 194223, Russia

Location

Teva Investigational Site 50457

Saint Petersburg, 197022, Russia

Location

Teva Investigational Site 50458

Tomsk, 634063, Russia

Location

Teva Investigational Site 31219

Barcelona, 8041, Spain

Location

Teva Investigational Site 31218

Valencia, 46017, Spain

Location

Teva Investigational Site 31217

Valencia, 46026, Spain

Location

Teva Investigational Site 58283

Chernivtsi, 58023, Ukraine

Location

Teva Investigational Site 58304

Dnipropetrovsk, 49074, Ukraine

Location

Teva Investigational Site 58287

Dnipropetrovsk, 49101, Ukraine

Location

Teva Investigational Site 58295

Ivano-Frankivsk, 76018, Ukraine

Location

Teva Investigational Site 58293

Kharkiv, 61002, Ukraine

Location

Teva Investigational Site 58289

Kharkiv, 61007, Ukraine

Location

Teva Investigational Site 58284

Kharkiv, 61035, Ukraine

Location

Teva Investigational Site 58288

Kharkiv, 61039, Ukraine

Location

Teva Investigational Site 58302

Kremenchuk, 39617, Ukraine

Location

Teva Investigational Site 58292

Kryvyi Rih, 50082, Ukraine

Location

Teva Investigational Site 58303

Kyiv, 2091, Ukraine

Location

Teva Investigational Site 58282

Kyiv, 3049, Ukraine

Location

Teva Investigational Site 58285

Kyiv, 3680, Ukraine

Location

Teva Investigational Site 58286

Kyiv, 3680, Ukraine

Location

Teva Investigational Site 58290

Kyiv, 3680, Ukraine

Location

Teva Investigational Site 58291

Kyiv, 4050, Ukraine

Location

Teva Investigational Site 58296

Kyiv, 4107, Ukraine

Location

Teva Investigational Site 58299

Kyiv, 4201, Ukraine

Location

Teva Investigational Site 58297

Sumy, 40022, Ukraine

Location

Teva Investigational Site 58294

Vinnytsia, 21001, Ukraine

Location

Teva Investigational Site 58301

Vinnytsia, 21001, Ukraine

Location

Teva Investigational Site 58298

Zaporizhzhya, 69063, Ukraine

Location

Teva Investigational Site 58300

Zaporizhzhya, 69118, Ukraine

Location

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.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: March 10, 2017
• Primary Completion: February 22, 2018
• Study Completion: February 22, 2018
• Last Updated: December 14, 2022
• Results First Posted: March 21, 2019

Record last verified: 2022-12

Locations

RO (5); CA (2); BE (3); IL (8); RU (9); ES (3); DE (13); UA (23); PL (10); US (37); CZ (4); FR (3); HU (14)