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 : May 15, 2018
|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|
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 24 weeks of treatment will continue onto the blinded 28-week Treatment Extension Phase. Following an initial screening at Visit 1, eligible subjects will be randomized to either CC-90001 200 mg or 400 mg PO QD or matching placebo beginning on Day 1 (Baseline Visit) of the study. Subjects completing the 24-week Double-blind Treatment Phase will continue the same blinded treatment assignment for 28 weeks in the Treatment Extension Phase. In the 28-week Treatment Extension Phase, all subjects will have the opportunity, if deemed appropriate by the Investigator, to use standard of care (SOC). The time to add and the choice of SOC will be at the Investigator's discretion. All subjects who complete the study treatment phases, or 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis|
|Actual Study Start Date :||July 26, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||August 13, 2020|
Experimental: CC-90001 400 mg PO QD
45 subjects will be randomized to CC-90001 400mg
CC-90001 is a potent, selective inhibitor of JNK.
Experimental: CC-90001 200 mg PO QD
45 subjects will be randomized to CC-90001 200mg
CC-90001 is a potent, selective inhibitor of JNK.
Placebo Comparator: Placebo PO QD
45 subjects will be randomized to placebo
- 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.
- 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:
- 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?
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142191
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
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|Study Chair:||Steven Greenberg, M.D||Celgene|