A Study of BMS-986278 in Participants with Progressive Pulmonary Fibrosis

UCI Specialty Area: Pulmonology

Principal Investigator: Huawei Dong

Official 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 (PPF).

A Study On:

Lung - Pulmonary

Study Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

Eligibility

Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and greater than or equal to 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.

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.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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