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

NCT ID: NCT01203943

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2012-08-24

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Fibrosis; Interstitial Lung Disease; Lung Diseases, Interstitial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM.

Group Type: EXPERIMENTAL

CC-930

Intervention Type: DRUG

CC-930 50 mg PO daily up to 56 weeks beginning on Day 1

Cohort 2

• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM

Group Type: EXPERIMENTAL

CC-930

Intervention Type: DRUG

CC-930 100 mg PO daily up to 56 weeks beginning on Day 1

Cohort 3

• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1.

Group Type: EXPERIMENTAL

CC-930

Intervention Type: DRUG

C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

CC-930

CC-930 50 mg PO daily up to 56 weeks beginning on Day 1

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

CC-930

CC-930 100 mg PO daily up to 56 weeks beginning on Day 1

Intervention Type: DRUG

CC-930

C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Smith, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

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

Countries

United States; Canada

References

van der Velden JL, Ye Y, Nolin JD, Hoffman SM, Chapman DG, Lahue KG, Abdalla S, Chen P, Liu Y, Bennett B, Khalil N, Sutherland D, Smith W, Horan G, Assaf M, Horowitz Z, Chopra R, Stevens RM, Palmisano M, Janssen-Heininger YM, Schafer PH. JNK inhibition reduces lung remodeling and pulmonary fibrotic systemic markers. Clin Transl Med. 2016 Dec;5(1):36. doi: 10.1186/s40169-016-0117-2. Epub 2016 Sep 2.

Reference Type: BACKGROUND

PMID: 27590145 (View on PubMed)

Other Identifiers

CC-930-IPF-001

Identifier Type: -

Identifier Source: org_study_id