Last updated on August 2020

A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Brief description of study

This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

Detailed Study Description

Approximately 165 adult male and female subjects with a confirmed diagnosis of Idiopathic pulmonary fibrosis (IPF) (according to the most recent IPF guideline for diagnosis and management) will be randomized 1:1:1 (55 subjects per arm) to treatment with oral CC-90001 (200 mg QD or 400 mg QD) or matching placebo for an initial 24 weeks.

The randomization will be stratified based on the concurrent administration of SOC (Yes/No). Subjects completing the 24-week Double-blind Treatment Phase will continue onto the 80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to receive placebo will be re-randomized 1:1 to blinded CC-90001 (200 mg or 400 mg PO QD). During the 80-week Active Treatment Extension Phase, all subjects not on concurrent SOC therapy will have the opportunity, if deemed appropriate by the Investigator, to receive allowed standard of care (SOC).

All subjects who complete the study treatment phases and those subjects who discontinue investigational product (IP) prior to the completion of the study will participate in the 4-week Post-treatment Observational Follow-up Phase.

The study will be conducted in compliance with the International Council Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

An external DMC, comprised of independent physician experts and a statistician who are not affiliated with the Sponsor and for whom there is no identified conflict of interest will be responsible for safeguarding study participants' interests and for monitoring the overall conduct of the study.

Clinical Study Identifier: NCT03142191

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University of Louisville

Louisville, KY United States
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The Lung and Research Center, LLC

Chesterfield, MO United States
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Mt. Sinai School of Medicine

New York, NY United States
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University of Utah Health Care

Salt Lake City, UT United States
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University of Vermont

Burlington, VT United States
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Mater Medical Centre

South Brisbane, Australia
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Flinders Medical Centre

Bedford Park, Australia
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Ural State Medical Academy

Ekaterinburg, Russian Federation
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City clinical hospital No 9

Izhevsk, Russian Federation
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TSBIH Territorial Clinical Hospital

Krasnoyarsk, Russian Federation
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Republican Hospital

Petrozavodsk, Russian Federation
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Vvedenskaya Hospital

St. Petersburg, Russian Federation
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National Taiwan University Hospital

Taipei, Zhongzheng Dist., Taiwan
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Birmingham Chest Clinic

Birmingham, United Kingdom
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Hinchingbrooke Hospital

Huntingdon, United Kingdom
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Aintree University Hospital

Liverpool (Walton Centre), United Kingdom
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Royal Victoria Infirmary

Newcastle, United Kingdom
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Salford Royal

Salford, United Kingdom
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Southampton General Hospital

Southhampton, United Kingdom
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Southmead Hospital

Westbury-on-Trym/ Bristol, United Kingdom
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Loma Linda Univ Medical Center

Loma Linda, CA United States
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University of Florida

Gainesville, FL United States
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Recruitment Status: Open

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