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
  • Fibrosis
  • Idiopathic Interstitial Pneumonias
  • Pathologic Processes
  • Lung Diseases, Interstitial
  • Lung Diseases
  • Respiratory Tract Diseases


Eligible Ages
Over 40 Years
Eligible Genders
Accepts Healthy Volunteers

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.

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.

Study Design

Phase 2
Study Type
Intervention Model
Parallel Assignment
Primary Purpose
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
CC-90001 400 mg PO QD
55 subjects will be randomized to CC-90001 400mg
  • Drug: CC-90001
    CC-90001 is a potent, selective inhibitor of JNK.
CC-90001 200 mg PO QD
55 subjects will be randomized to CC-90001 200mg
  • Drug: CC-90001
    CC-90001 is a potent, selective inhibitor of JNK.
Placebo Comparator
Placebo PO QD
55 subjects will be randomized to placebo
  • Other: Placebo

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212

More Details


Study Contact

Associate Director Clinical Trial Disclosure

Detailed Description

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-90001 (200 mg QD or 400 mg QD) or 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 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 not on concurrent SOC therapy will have the opportunity, if deemed appropriate by the Investigator, to receive allowed standard of care (SOC).

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 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.