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Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis

  • Status
    Accepting Candidates
  • Age
    21 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

Details

Full study title A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis
Protocol number OCR35024
ClinicalTrials.gov ID NCT04308681
Phase Phase 2

Eligibility

Inclusion Criteria:

For the idiopathic pulmonary fibrosis (IPF) Cohort

  • Diagnosis of IPF within 7 years of screening

  • Female and males ≥ 40 years of age

For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort

  • Evidence of progressive ILD within the 24 months before screening

  • Female and male ≥ 21 years of age.

Exclusion Criteria:

  • Women of childbearing potential (WOCBP)

  • Active Smokers

  • Current malignancy or previous malignancy up to 5 years prior to screening

  • History of allergy to BMS-986278 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.