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

• Status: Terminated
• Trial end date: 2012-08-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

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