Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis
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StatusAccepting Candidates
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Age21 Years - N/A
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SexesAll
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Healthy VolunteersNo
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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Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
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
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Step2
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.
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Step3
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.
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Step4
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.