A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial

In brief

The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.

Key facts

Study ID

NCT01203943

Run by

Celgene

People needed

28

Starts

2011-01-01

Expected to finish

2012-08-24

Last updated by the study team

2019-11-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females of non-childbearing potential ≥50 years of age (at the time of signing the informed consent document) with documented IPF
• Diagnosis of IPF based on current ATS/ERS guidelines
• Usual interstitial pneumonia (UIP) pattern on HRCT and/or UIP pattern on histopathology (ie surgical lung biopsy), and
• Exclusion of known causes of interstitial lung disease (such as environmental exposure, connective tissue disease and drug toxicity), Or
• UIP pattern on surgical lung biopsy required if HRCT is inconsistent with UIP

You may not qualify if…

• FVC : < 50% predicted >90% predicted
• DLco:< 25% predicted >90% predicted
• Saturated oxygen (SpO2) of <92% (room air [sea level] at rest). SpO2 of < 88% (room air [≥ 5,000 feet above sea level (1524 meters]) at rest)
• Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 12.5 mg/day or equivalent) including, but not limited to, azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks of screening
• Use of any cytokine modulators:
• Use of any biologic agent (such as etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 12 weeks or five half-lives of screening, and in the case of rituximab, use within 24 weeks of screening or no recovery of CD 19-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to screening
• Alefacept within 24 months of randomization
• Use of any therapy targeted to treat IPF (including but not limited to d-penicillamine, endothelium receptor antagonist [eg bosentan, ambrisentan], interferon gamma-1B, pirfenidone) within 4 weeks of screening
• Use of n-acetylcysteine (NAC) for IPF (≥1800 mg/day) within 4 weeks of screening
• Use of any investigational drug within one month of screening, or 5 PD/PK half lives, if known (whichever is longer)
• Current smoker

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine — Sacramento, California, United States
• Stanford University, Pulmonary & Critical Care Clinic — Stanford, California, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Geisenger Center for Clinical Studies — Danville, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas — Galveston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Vermont Lung Center — Colchester, Vermont, United States
• University of Calgary, Peter Lougheed Centre — Calgary, Alberta, Canada
• University of Alberta — Edmonton, Alberta, Canada
• Vancouver General Hospital/University of British Columbia — Vancouver, British Columbia, Canada
• St. Boniface Hospital — Winnipeg, Manitoba, Canada
• Victoria Hospital — London, Ontario, Canada
• Notre-Dame Hospital du CHUM — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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