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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases

In brief

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.

Key facts

Study ID

NCT03142191

Run by

Celgene

People needed

138

Starts

2017-07-26

Expected to finish

2021-12-24

Last updated by the study team

2023-06-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject understands and has voluntarily signed and dated an informed consent form
• Subject is male or female ≥ 40 years of age
• Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy [SLB] or cryobiopsy) if available according to guidelines.
• No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed.
• Percent predicted forced vital capacity (% FVC) ≥ 45% and ≤ 95% at Screening
• Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at Screening.
• Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening
• Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods.
• Male subjects must practice true abstinence or use a barrier method of contraception.
• Additional inclusion criteria apply.
• Progressive Pulmonary Fibrosis (PPF) Sub-Study:
• Met all inclusion criteria described for IPF subjects other than Inclusion Criterion 5.
• Features of diffuse fibrosing lung disease of > 10% on HRCT by central reading.
• Investigator-documented ≥ 5% annualized relative decline in FVC in past 24 months from Screening Visit 1

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject with a QTcF > 450 msec.
• Evidence of clinically relevant airways obstruction at Screening.
• Subjects using therapy targeted to treat IPF.
• History of latent or active TB, unless there is medical record documentation of successful completion of a standard course of treatment
• History of hepatitis B and/or hepatitis C, including those considered successfully treated/cured
• Pregnancy or lactation.
• Additional exclusion criteria apply.

Where it is running

• Cedars Sinai Medical Center Rheumatology — Los Angeles, California, United States
• Local Institution - 514 — Sacramento, California, United States
• University of California Davis Health System — Sacramento, California, United States
• Stanford University Pulmonary and Critical Care Clinic — Stanford, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami and Sylvester Cancer Center — Miami, Florida, United States
• University of Louisville — Louisville, Kentucky, United States
• The Lung and Research Center, LLC — Chesterfield, Missouri, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Duke University Health System - Duke Pulmonary Transplant Clinic — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Pulmonary & Sleep Center of Oklahoma — Tulsa, Oklahoma, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Local Institution - 502 — Dallas, Texas, United States
• University of Utah Health Care — Salt Lake City, Utah, United States
• University of Vermont — Burlington, Vermont, United States
• Local Institution - 608 — Camperdown, New South Wales, Australia
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Mater Medical Centre — South Brisbane, Queensland, Australia
• Loma Linda Univ Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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