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

Phase 2

Terminated

• Conditions: Fibrosis; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Interventions: Drug: CC-930; Other: Placebo

• Registration Number: NCT01203943
• Lead Sponsor: Celgene

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2011-01-01
• Primary Completion: 2012-01-31
• Study Completion: 2012-08-24
• Disposition First Submitted: 2013-09-05
• Disposition First Submitted QC: 2013-09-05
• Disposition First Posted: 2013-09-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	CC-930	• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM.
Cohort 2	CC-930	• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM
Cohort 3	CC-930	• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1.
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety	Week 4	Number of participants with adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics-Vz/f	Week 0 (baseline) and week 2	Apparent volume of distribution
Pharmacokinetics-CL/F	Week 0 (baseline) and week 2	Apparent total body clearance
Long-term safety	Weeks 52-104	Number of participants with adverse events
Disease progression/death rates	Weeks 52-104	Time to disease progression and death from week 52
Pharmacokinetics-Cmax	Week 1 (baseline) and week 2	Maximum observed concentration in plasma
Pharmacokinetics-Cmin	Week 0 (baseline) and week 2	Minimum observed concentration in plasma
Pharmacokinetics-AUC	Week 0 (baseline) and week 2	Area under the plasma concentration - time curve
Pharmacokinetics-Tmax	Week 0 (baseline) and week 2	Time to reach Cmax
Pharmacokinetics - t 1/2	Week 0 (baseline) and week 2	Terminal half-life (t1/2)

Trial Locations

Locations (22)

Vancouver General Hospital/University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of Texas; 🇺🇸 Galveston, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Geisenger Center for Clinical Studies; 🇺🇸 Danville, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine; 🇺🇸 Sacramento, California, United States

Victoria Hospital; 🇨🇦 London, Ontario, Canada

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Vermont Lung Center; 🇺🇸 Colchester, Vermont, United States

Notre-Dame Hospital du CHUM; 🇨🇦 Montreal, Quebec, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Stanford University, Pulmonary & Critical Care Clinic; 🇺🇸 Stanford, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Calgary, Peter Lougheed Centre; 🇨🇦 Calgary, Alberta, Canada