A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.
- Idiopathic Pulmonary Fibrosis
- Idiopathic Interstitial Pneumonias
- Pathologic Processes
- Lung Diseases, Interstitial
- Lung Diseases
- Respiratory Tract Diseases
- Eligible Ages
- Over 40 Years
- Eligible Genders
- Accepts Healthy Volunteers
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject understands and has voluntarily signed and dated an informed consent form
2. Subject is male or female ≥ 40 years of age
3. Subject was diagnosed with IPF within 5 years of Screening
4. Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy [SLB] or cryobiopsy) if available according to guidelines.
5. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed.
6. Percent predicted forced vital capacity (% FVC) ≥ 45% and ≤ 95% at Screening
7. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at Screening.
8. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening
9. Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods.
10. Male subjects must practice true abstinence or use a barrier method of contraception.
11. Additional inclusion criteria apply.
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 any 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
CC-90001 400 mg PO QD
|45 subjects will be randomized to CC-90001 400mg||
CC-90001 200 mg PO QD
|45 subjects will be randomized to CC-90001 200mg||
Placebo PO QD
|45 subjects will be randomized to placebo||
- NCT ID
Study ContactAssociate Director Clinical Trial Disclosure
Approximately 135 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 (45 subjects per arm) to treatment with oral CC-90001 (200 mg QD or 400 mg QD) or matching placebo for an initial 24 weeks.
Subjects completing the 24-week Double-blind Treatment Phase will continue onto the blinded 80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to placebo will be re-randomized 1:1 to blinded CC-90001 (200 mg or 400 mg PO QD). During the 80-week Active Treatment Extension Phase, all subjects will have the opportunity, if deemed appropriate by the Investigator, to receive standard of care (SOC). The time to add SOC and the choice of SOC during the Extension Phase will be at the Investigator's discretion.
All subjects who complete the study treatment phases and those subjects who discontinue investigational product (IP) prior to the completion of the study will participate in the 4-week Post-treatment Observational Follow-up Phase.
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
An external DMC, comprised of independent physician experts and a statistician who are not affiliated with the Sponsor and for whom there is no identified conflict of interest will be responsible for safeguarding study participants' interests and for monitoring the overall conduct of the study.