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

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ClinicalTrials.gov Identifier: NCT03142191
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE April 24, 2017
First Posted Date  ICMJE May 5, 2017
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE July 26, 2017
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03142191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • 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
  • 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)
  • Disease Progression [ Time Frame: Up to approximately 24 weeks ]
    Time to disease progression
  • 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.
  • 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).
  • 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
  • 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?
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • 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
  • 6-minute Walk Test (6MWT) with Borg Scale [ Time Frame: Up to approximately 52 weeks ]
    Change in the distance walked during the 6MWT as measured in meters (m)
  • Disease Progression [ Time Frame: Up to approximately 24 weeks ]
    Time to disease progression
  • 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.
  • 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).
  • Adverse Events (AEs) [ Time Frame: Up to approximately 56 Weeks ]
    Type, frequency, severity, and relationship of AEs, clinical laboratory tests including urine cytology, 12-lead ECG, vital signs, and physical examination
  • Borg Scale [ Time Frame: Up to approximately 52 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?
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Pulmonary Fibrosis
  • Fibrosis
  • Idiopathic Interstitial Pneumonias
  • Pathologic Processes
  • Lung Diseases, Interstitial
  • Lung Diseases
  • Respiratory Tract Diseases
Intervention  ICMJE
  • Drug: CC-90001
    CC-90001 is a potent, selective inhibitor of JNK.
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: CC-90001 400 mg PO QD
    55 subjects will be randomized to CC-90001 400mg
    Intervention: Drug: CC-90001
  • Experimental: CC-90001 200 mg PO QD
    55 subjects will be randomized to CC-90001 200mg
    Intervention: Drug: CC-90001
  • Placebo Comparator: Placebo PO QD
    55 subjects will be randomized to placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2019)
210
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2017)
135
Estimated Study Completion Date  ICMJE January 26, 2023
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Colombia,   Germany,   Greece,   Romania,   Russian Federation,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT03142191
Other Study ID Numbers  ICMJE CC-90001-IPF-001
2016-003473-17 ( EudraCT Number )
U1111-1192-8549 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zoran Popmihajlov, MD Celgene
PRS Account Celgene
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP