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

NCT01203943 | Terminated Phase 2 DMC

• 1 other identifier: CC-930-IPF-001
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 22

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

Keywords

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Fibrosis; Interstitial Lung Disease; Lung Diseases, Interstitial; CC-930

Outcome Measures

Primary Outcomes (1)

• Safety

  Number of participants with adverse events

  Week 4

Secondary Outcomes (10)

• Long-term safety

  Weeks 52-104

• Disease progression/death rates

  Up to week 56

• Disease progression/death rates

  Weeks 52-104

• Pharmacokinetics-Cmax

  Week 1 (baseline) and week 2

• Pharmacokinetics-Cmin

  Week 0 (baseline) and week 2

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: CC-930

Cohort 2

EXPERIMENTAL

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

Drug: CC-930

Cohort 3

EXPERIMENTAL

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

Drug: CC-930

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CC-930 DRUG

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

Cohort 1

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine

Sacramento, California, 95817, United States

Location

Stanford University, Pulmonary & Critical Care Clinic

Stanford, California, 94305, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33101, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Geisenger Center for Clinical Studies

Danville, Pennsylvania, 17822, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas

Galveston, Texas, 77555, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

University of Calgary, Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

Vancouver General Hospital/University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

Notre-Dame Hospital du CHUM

Montreal, Quebec, H2L4M1, Canada

Location

Related Publications (1)

• 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.

  PMID: 27590145 BACKGROUND

MeSH Terms

Conditions

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

Interventions

4-(9-(tetrahydrofuran-3-yl))-8-(2,4,6-trifluorophenylamino)-9H-purin-2-ylaminocyclohexan-1-ol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Smith, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: January 1, 2011
• Primary Completion: January 31, 2012
• Study Completion: August 24, 2012
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

US (16); CA (6)