ALOFT-PPF
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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 evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
Details
Full study title | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis |
Protocol number | OCR44600 |
ClinicalTrials.gov ID | NCT06025578 |
Phase | Phase 3 |
Eligibility
Inclusion Criteria
Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and 鈮� 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
Exclusion Criteria
Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
History of stroke or transient ischemic attack within 3 months prior to screening.
Participants who exhibit symptoms of heart failure at rest.
Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
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.