Last updated on March 2019

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 135 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 (45 subjects per arm) to treatment with oral CC-90001 (200 mg QD or 400 mg QD) or matching placebo for an initial 24 weeks.

Subjects completing the 24-week Double-blind Treatment Phase will continue onto the blinded 80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to 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 will have the opportunity, if deemed appropriate by the Investigator, to receive standard of care (SOC). The time to add SOC and the choice of SOC during the Extension Phase will be at the Investigator's discretion.

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 on 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

Contact Investigators or Research Sites near you

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Vvedenskaya Hospital

St. Petersburg, Russian Federation
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FSBHI Clincial Research Institute of Phithisioplulmonoloyg

Saint Petersburg, Russian Federation
1.09miles
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Pavlov First Saint Petersburg State Medical University

Saint-Petersburg, Russian Federation
2.89miles
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Recruitment Status: Open


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