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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT03142191

Recruitment Status Recruiting

First Posted May 5, 2017

Last update posted January 19, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Fibrosis
    Respiratory Tract Diseases
    Idiopathic Pulmonary Fibrosis
    Idiopathic Interstitial Pneumonias
    Pathologic Processes
    Lung Diseases, Interstitial
    Lung Diseases
  • Intervention/Treatment: Drug: CC-90001
    Other: Placebo
  • Phase: Phase 2
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 210 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
  • Actual Study Start Date: July 2017
  • Estimated Primary Completion Date: September 2022
  • Estimated Study Completion Date: February 2024
Arms and interventions
Arm Intervention/treatment
Experimental: 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.
Experimental: 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.
Placebo Comparator: Placebo PO QD
55 subjects will be randomized to placebo
Other: Placebo
Placebo
Outcome Measures
  • Primary Outcome Measures: 1. Percentage point change in % predicted Forced vital capacity (FVC) [ Time Frame: Up to approximately 24 weeks ]
    Mean change from Baseline of percent predicted FVC value between either active treatment group and the placebo group.
  • Secondary Outcome Measures: 1. Absolute change and rate of decline in FVC [ Time Frame: Up to approximately 24 weeks ]
    Absolute change and rate of decline in FVC (expressed in mL) from baseline through Week 24
  • 2. 6-minute Walk Test (6MWT) with Borg Scale [ Time Frame: Up to approximately 104 weeks ]
    Change in the distance walked during the 6MWT as measured in meters (m)
  • 3. Disease Progression [ Time Frame: Up to approximately 24 weeks ]
    Time to disease progression
  • 4. Quality of Life - Saint George's Respiratory [ Time Frame: Up to approximately 24 weeks ]
    The SGRQ is a quality of life health questionnaire that has been validated in IPF. It consists of 76 items in three domains: Symptoms Activity Impact of disease on daily life.
  • 5. Quality of life- University of California San Diego Shortness of Breath Questionnaire (UCSD- SOBQ) [ Time Frame: Up to approximately 24 weeks ]
    The UCSD-SOBQ is a 24-item dyspnea questionnaire that asks subjects to rate themselves from 0 ("Not at all") to 5 ("Maximally or unable to do because of breathlessness") in two areas: 1) how short of breath they are while performing various activities (21 items); and 2) how much shortness of breath, fear of hurting themselves by overexerting, and fear of shortness of breath limit them in their daily lives (3 items).
  • 6. Adverse Events (AEs) [ Time Frame: Up to Week 108 ]
    Type, frequency, severity, and relationship of AEs, clinical laboratory tests including urine cytology, 12-lead ECG, vital signs, and physical examination
  • 7. Borg Scale [ Time Frame: Up to approximately 104 weeks ]
    This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal. How much difficulty is your breathing causing you right now?
Eligibility Criteria
  • Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

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.

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 94 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Chair: Zoran Popmihajlov, MD Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03142191 History of Changes
  • Other Study ID Numbers: CC-90001-IPF-001, 2016-003473-17, U1111-1192-8549
  • First Posted: May 5, 2017 Key Record Dates
  • Last Update Posted: January 19, 2021
  • Last Verified: January 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Idiopathic Pulmonary Fibrosis (IPF)
    Pulmonary Fibrosis
    CC-90001
    Safety
    Efficacy
    IPF
    idiopathic pulmonary fibrosis
  • Additional relevant MeSH terms: Fibrosis
    Lung Diseases
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Respiratory Tract Diseases
    Lung Diseases, Interstitial
    Idiopathic Interstitial Pneumonias
    Pathologic Processes