Clinical Trials in France / NCT06003426
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
NCT06003426 · tracked via the Priya Life Science France tracker
Condition(s) studied
Idiopathic Pulmonary Fibrosis
Investigational drug(s) / intervention(s)
BMS-986278 →BMS-986278 Placebo
BMS-986278: Specified dose on specified days
BMS-986278 Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Eligibility
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
Primary outcome measure(s)
- Number of participants that experience spontaneous syncopal events — At approximately 4 weeks
Cohort 1 - Absolute change from baseline in forced vital capacity (FVC) measured in mL — Up to Week 52
Cohort 2
Trial sites (390)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0189 | Birmingham | Alabama | |
| Local Institution - 0361 | Phoenix | Arizona | |
| Local Institution - 0396 | La Jolla | California | |
| Local Institution - 0193 | Los Angeles | California | |
| Local Institution - 0398 | Los Angeles | California | |
| Local Institution - 0389 | Orange | California | |
| Local Institution - 0405 | Sacramento | California | |
| Local Institution - 0185 | San Francisco | California | |
| Local Institution - 0186 | Stanford | California | |
| Local Institution - 0363 | Aurora | Colorado | |
| Local Institution - 0194 | Denver | Colorado | |
| Local Institution - 0175 | New Haven | Connecticut | |
| Local Institution - 0151 | Newark | Delaware | |
| Local Institution - 0367 | Washington D.C. | District of Columbia | |
| Local Institution - 0101 | Brandon | Florida | |
| Local Institution - 0436 | Clearwater | Florida | |
| Local Institution - 0425 | DeBary | Florida | |
| Local Institution - 0079 | Gainesville | Florida | |
| Local Institution - 0352 | Hialeah | Florida | |
| Local Institution - 0370 | Kissimmee | Florida | |
| Local Institution - 0502 | Leesburg | Florida | |
| Local Institution - 0153 | Loxahatchee Groves | Florida | |
| Local Institution - 0187 | Ocala | Florida | |
| Local Institution - 0418 | Pensacola | Florida | |
| Local Institution - 0206 | St. Petersburg | Florida | |
| Local Institution - 0364 | Tampa | Florida | |
| Local Institution - 0372 | Dublin | Georgia | |
| Local Institution - 0178 | Chicago | Illinois | |
| Local Institution - 0183 | Chicago | Illinois | |
| Local Institution - 0058 | Chicago | Illinois | |
| Local Institution - 0085 | Maywood | Illinois | |
| Local Institution - 0325 | Peoria | Illinois | |
| Local Institution - 0180 | Iowa City | Iowa | |
| Local Institution - 0204 | Kansas City | Kansas | |
| Local Institution - 0393 | Louisville | Kentucky | |
| Local Institution - 0354 | Baltimore | Maryland | |
| Local Institution - 0380 | Boston | Massachusetts | |
| Local Institution - 0040 | Boston | Massachusetts | |
| Local Institution - 0472 | Ann Arbor | Michigan | |
| Local Institution - 0096 | Chesterfield | Missouri |
+ 350 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06003426 on ClinicalTrials.gov ↗ ← All trials in France