A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Launched by CELGENE · May 3, 2017

Keywords

ClinConnect Summary

Approximately 165 adult male and female subjects with a confirmed diagnosis of Idiopathic pulmonary fibrosis (IPF) (according to the most recent IPF guideline for diagnosis and management) will be randomized 1:1:1 (55 subjects per arm) to treatment with oral CC-90001or matching placebo for an initial 24 weeks.

The randomization will be stratified based on the concurrent administration of SOC (Yes/No). Subjects completing the 24-week Double-blind Treatment Phase will continue onto the 80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to receive placebo...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject understands and has voluntarily signed and dated an informed consent form
• • 1. Subject is male or female ≥ 40 years of age
• • 2. Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy \[SLB\] or cryobiopsy) if available according to guidelines.
• • 3. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed.
• • 4. Percent predicted forced vital capacity (% FVC) ≥ 45% and ≤ 95% at Screening
• • 5. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at Screening.
• • 6. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening
• • 7. Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods.
• • 8. Male subjects must practice true abstinence or use a barrier method of contraception.
• • 9. Additional inclusion criteria apply.
• Progressive Pulmonary Fibrosis (PPF) Sub-Study:
• • 1. Met all inclusion criteria described for IPF subjects other than Inclusion Criterion 5.
• • 2. Features of diffuse fibrosing lung disease of \> 10% on HRCT by central reading.
• • 3. Investigator-documented ≥ 5% annualized relative decline in FVC in past 24 months from Screening Visit 1
• Exclusion Criteria:
• The presence of any of the following will exclude a subject from enrollment:
• • 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• • 2. Subject with a QTcF \> 450 msec.
• • 3. Evidence of clinically relevant airways obstruction at Screening.
• • 4. Subjects using therapy targeted to treat IPF.
• • 5. History of latent or active TB, unless there is medical record documentation of successful completion of a standard course of treatment
• • 6. History of hepatitis B and/or hepatitis C, including those considered successfully treated/cured
• • 7. Pregnancy or lactation.
• • 8. Additional exclusion criteria apply.