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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142191
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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 Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Fibrosis Idiopathic Interstitial Pneumonias Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Drug: CC-90001 Other: Placebo 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-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 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).

The exploratory Progressive Pulmonary Fibrosis (PPF) sub study will evaluate the efficacy, safety, PK, quality of life and exploratory PD of one PO treatment dose regimen of CC-90001, compared with placebo, for an initial 24 weeks of treatment, in subjects with PPF and long-term safety in the 80-week Active Treatment Extension Phase when all PPF subjects will receive CC-90001. Approximately 45 non-SOC subjects will be randomized in this sub study.

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 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 26, 2017
Actual Primary Completion Date : December 24, 2021
Actual Study Completion Date : December 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
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.
Placebo Comparator: Placebo PO QD
55 subjects will be randomized to placebo
 Other: Placebo
Placebo
Experimental: CC-90001 400 mg PO QD- Sub-Study
30 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- Sub-Study
15 subjects will be randomized to placebo
 Other: Placebo
Placebo


Outcome Measures
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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
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Information from the National Library of Medicine

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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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142191


Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03142191    
Other Study ID Numbers: CC-90001-IPF-001
2016-003473-17 ( EudraCT Number )
U1111-1192-8549 ( Registry Identifier: WHO )
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022

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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:
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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases
Lung Diseases, Interstitial
 Idiopathic Interstitial Pneumonias
Hamman-Rich Syndrome
Fibrosis
Pathologic Processes