Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2026
Estimated Enrollment :
1255 Patients enrolled
Trial Details
Trial ID
NCT06003426
Start Date
September 14 2023
End Date
October 26 2026
Last Update
September 29 2025
Active Locations (390)
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1
Local Institution - 0189
Birmingham, Alabama, United States, 35294
2
Local Institution - 0361
Phoenix, Arizona, United States, 85013-4220
3
Local Institution - 0396
La Jolla, California, United States, 92037-1027
4
Local Institution - 0193
Los Angeles, California, United States, 90033-5313