A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
a study on Fibrosis Interstitial Lung Disease Arthritis Rheumatoid Arthritis Sarcoidosis Diffuse Scleroderma
Summary
- Eligibility
- for people ages 21 years and up (full criteria)
- Location
- at UC Davis UC Irvine UCLA UCSF
- Dates
- study startedstudy ends around
Description
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
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
Keywords
Progressive Pulmonary Fibrosis, BMS-986278, LPA1 antagonist, Pulmonary fibrosis, Interstitial lung disease, Rheumatoid Arthritis, Connective Tissue Disorders, Sarcoidosis, Scleroderma, Fibrosis, Antifibrotic therapy, Interstitial Lung Diseases, Connective Tissue Diseases, Diffuse Scleroderma
Eligibility
You can join if…
Open to people ages 21 years and up
- Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 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.
You CAN'T join if...
- 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; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
- 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.
Locations
- David Geffen School of Medicine at UCLA
accepting new patients
Los Angeles 5368361 California 5332921 90095-3075 United States - UC Irvine Medical Center
accepting new patients
Orange 5379513 California 5332921 92868-3201 United States - University of California UC Davis Medical Center
accepting new patients
Sacramento 5389489 California 5332921 95817 United States - University of California, San Francisco Medical Center- Pulmonary Practice
accepting new patients
San Francisco 5391959 California 5332921 94143-2202 United States - Scripps Clinic Torrey Pines
accepting new patients
La Jolla 5363943 California 5332921 92037-1027 United States - Local Institution - 0066
not yet accepting patients
La Jolla 5363943 California 5332921 92093 United States - Local Institution - 0535
not yet accepting patients
Newport Beach 5376890 California 5332921 92663-3661 United States - University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic
accepting new patients
Los Angeles 5368361 California 5332921 90033-5313 United States - Stanford Hospital and Clinics
accepting new patients
Stanford 5398563 California 5332921 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Bristol-Myers Squibb
- Links
- BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
- ID
- NCT06025578
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 1092 study participants
- Last Updated