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

This study is currently recruiting participants.
Verified October 2017 by Celgene
Sponsor:
ClinicalTrials.gov Identifier:
NCT03142191
First Posted: May 5, 2017
Last Update Posted: November 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • 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:
  • 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?


Estimated Enrollment: 135
Actual Study Start Date: July 26, 2017
Estimated Study Completion Date: August 13, 2020
Estimated Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CC-90001 400 mg PO QD
45 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
45 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
45 subjects will be randomized to placebo
Other: Placebo
Placebo

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject understands and has voluntarily signed and dated an informed consent form
  2. Subject is male or female ≥ 40 years of age
  3. Subject was diagnosed with IPF within 4 years of Screening
  4. Diagnosis of IPF is supported by HRCT and historical surgical lung biopsy (SLB) if available according to guidelines.
  5. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed.
  6. Percent predicted forced vital capacity (% FVC) ≥ 45% at Screening
  7. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 85% predicted at Screening.
  8. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening
  9. Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods.
  10. Male subjects must practice true abstinence or use a barrier method of contraception.
  11. 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 QTc calculation using Fridericia's formula (QTcF) > 450 msec.
  3. Evidence of clinically relevant airways obstruction at Screening.
  4. Subjects using any therapy targeted to treat Idiopathic pulmonary fibrosis (IPF).
  5. Use of ≥ 15 hours of supplemental oxygen per day or resting arterial oxygen saturation by pulse oximetry (SpO2) of < 92% (room air at sea level) or resting SpO2 of < 88% (room air at ≥ 5000 feet [1524 meters] above sea level).
  6. Pregnancy or lactation.
  7. Additional exclusion criteria apply.
  Contacts and Locations
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


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

  Show 63 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Chair: Steven Greenberg, M.D Celgene
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03142191     History of Changes
Other Study ID Numbers: CC-90001-IPF-001
2016-003473-17 ( EudraCT Number )
U1111-1192-8549 ( Registry Identifier: WHO )
First Submitted: April 24, 2017
First Posted: May 5, 2017
Last Update Posted: November 2, 2017
Last Verified: October 2017

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
Pneumonia
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases, Interstitial
Respiratory Tract Infections