Evaluating a new treatment for Idiopathic Pulmonary Fibrosis
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
PHASE3 · Bristol-Myers Squibb · NCT06003426
This study is testing a new medication called BMS-986278 to see if it can help people with Idiopathic Pulmonary Fibrosis feel better and stay safe.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1185 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Locations | 503 sites (Birmingham, Alabama and 502 other locations) |
| Trial ID | NCT06003426 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy, safety, and tolerability of a medication called BMS-986278 in individuals diagnosed with Idiopathic Pulmonary Fibrosis (IPF). Participants will receive either the active drug or a placebo, and their responses will be monitored over the course of the trial. The study is designed for patients aged 40 and older who have been diagnosed with IPF within the last seven years. It will also consider participants who are currently on stable doses of other IPF medications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of Idiopathic Pulmonary Fibrosis within the last seven years.
Not a fit: Patients with recent history of stroke or transient ischemic attack, or those exhibiting symptoms of heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Idiopathic Pulmonary Fibrosis.
How similar studies have performed: Other studies have shown promise with similar approaches targeting IPF, but the specific efficacy of BMS-986278 is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Subjects with IPF aged ≥ 40 years at the time of signing the informed consent. * Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia. * 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. * 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 * 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 with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Birmingham, Alabama and 502 other locations
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Local Institution - 0179 — Jasper, Alabama, United States (NOT_YET_RECRUITING)
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (RECRUITING)
- Scripps Clinic Torrey Pines — La Jolla, California, United States (RECRUITING)
- Local Institution - 0112 — La Jolla, California, United States (NOT_YET_RECRUITING)
- University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic — Los Angeles, California, United States (RECRUITING)
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (RECRUITING)
- Local Institution - 0501 — Newport Beach, California, United States (NOT_YET_RECRUITING)
- UC Irvine Medical Center — Orange, California, United States (RECRUITING)
- University of California UC Davis Medical Center — Sacramento, California, United States (RECRUITING)
- University of California, San Francisco Medical Center- Pulmonary Practice — San Francisco, California, United States (RECRUITING)
- Stanford University School of Medicine — Stanford, California, United States (RECRUITING)
- University of Colorado Anschutz Medical Campus - Department of Family Medicine — Aurora, Colorado, United States (RECRUITING)
- National Jewish Health — Denver, Colorado, United States (RECRUITING)
- Yale New Haven Hospital — New Haven, Connecticut, United States (RECRUITING)
- Christiana Care Pulmonary Associates - Newark — Newark, Delaware, United States (RECRUITING)
- Medstar Georgetown University Hospital — Washington, District of Columbia, United States (RECRUITING)
- Meris Clinical Research — Brandon, Florida, United States (RECRUITING)
- St Francis Sleep Allergy & Lung Institute — Clearwater, Florida, United States (RECRUITING)
- Omega Research Consultants LLC — DeBary, Florida, United States (RECRUITING)
- Local Institution - 0060 — Gainesville, Florida, United States (NOT_YET_RECRUITING)
- University of Florida (UF) Health Shands Hospital — Gainesville, Florida, United States (RECRUITING)
- Harmony Medical Research Institute, Inc — Hialeah, Florida, United States (RECRUITING)
- Clinical Research Specialists, LLC - Kissimmee — Kissimmee, Florida, United States (RECRUITING)
- Local Institution - 0502 — Leesburg, Florida, United States (NOT_YET_RECRUITING)
- Pulmonary Specialists of the Palm Beaches — Loxahatchee Groves, Florida, United States (RECRUITING)
- Local Institution - 0401 — Miami, Florida, United States (NOT_YET_RECRUITING)
- Ocala Lung & Critical Care — Ocala, Florida, United States (RECRUITING)
- Avanza Medical Research Center — Pensacola, Florida, United States (RECRUITING)
- Coastal Pulmonary & Critical Care, P.L.C. — Saint Petersburg, Florida, United States (RECRUITING)
- University of South Florida — Tampa, Florida, United States (RECRUITING)
- Local Institution - 0412 — Weston, Florida, United States (NOT_YET_RECRUITING)
- Local Institution - 0452 — Atlanta, Georgia, United States (NOT_YET_RECRUITING)
- Pulmonology, Sleep, Asthma & Allergy Center of Dublin — Dublin, Georgia, United States (RECRUITING)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (RECRUITING)
- Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building — Chicago, Illinois, United States (RECRUITING)
- The University of Chicago Medicine — Chicago, Illinois, United States (RECRUITING)
- Local Institution - 0094 — Evanston, Illinois, United States (NOT_YET_RECRUITING)
- Loyola University Health System — Maywood, Illinois, United States (RECRUITING)
- OSF Saint Francis Medical Center — Peoria, Illinois, United States (RECRUITING)
- Local Institution - 0190 — Indianapolis, Indiana, United States (NOT_YET_RECRUITING)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (RECRUITING)
- University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States (RECRUITING)
- Norton Pulmonary Specialists — Louisville, Kentucky, United States (RECRUITING)
- Local Institution - 0435 — Louisville, Kentucky, United States (NOT_YET_RECRUITING)
- University of Maryland - Marlene and Stewart Greenebaum Cancer Center — Baltimore, Maryland, United States (RECRUITING)
- Local Institution - 0043 — Towson, Maryland, United States (NOT_YET_RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Local Institution - 0439 — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Steward St. Elizabeth Medical Center — Boston, Massachusetts, United States (RECRUITING)
+453 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Idiopathic Pulmonary Fibrosis, BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis