A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idi… (NCT06003426) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
United States1,255 participantsStarted 2023-09-14
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Who can participate
Age range40 Years
SexALL
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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
What they're measuring
1
Number of participants that experience spontaneous syncopal events
Timeframe: At approximately 4 weeks
2
Absolute change from baseline in forced vital capacity (FVC) measured in mL