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

Celgene

Status and phase: Terminated; Phase 2

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

Treatments: Drug: CC-930; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203943

CC-930-IPF-001

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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28 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: CC-930

Drug: CC-930

Drug: CC-930

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: CC-930

Drug: CC-930

Drug: CC-930

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: CC-930

Drug: CC-930

Drug: CC-930

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo