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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01203943
• Date of registration: 15/09/2010
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
• Date of first enrolment: January 1, 2011
• Target sample size: 28
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01203943
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: William Smith, MD
• Affiliation: Celgene Corporation

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Interstitial Lung Disease

Pulmonary Fibrosis

Fibrosis

Idiopathic Pulmonary Fibrosis

Lung Diseases, Interstitial

Intervention(s)

Other: Placebo

Drug: CC-930

Primary Outcome(s)

Safety [Time Frame: Week 4]

Secondary Outcome(s)

Pharmacokinetics - t 1/2 [Time Frame: Week 0 (baseline) and week 2]

Pharmacokinetics-AUC [Time Frame: Week 0 (baseline) and week 2]

Pharmacokinetics-Cmin [Time Frame: Week 0 (baseline) and week 2]

Disease progression/death rates [Time Frame: Up to week 56]

Disease progression/death rates [Time Frame: Weeks 52-104]

Long-term safety [Time Frame: Weeks 52-104]

Pharmacokinetics-Cmax [Time Frame: Week 1 (baseline) and week 2]

Pharmacokinetics-Vz/f [Time Frame: Week 0 (baseline) and week 2]

Pharmacokinetics-CL/F [Time Frame: Week 0 (baseline) and week 2]

Pharmacokinetics-Tmax [Time Frame: Week 0 (baseline) and week 2]

Secondary ID(s)

CC-930-IPF-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors