A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: BMS-986278; Drug: BMS-986278 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06003426

IM027-068

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

Enrollment: 1,185 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,185 participants in 3 patient groups, including a placebo group

BMS-986278 Dose 1

Experimental group

Treatment:

Drug: BMS-986278

BMS-986278 Dose 2

Experimental group

Treatment:

Drug: BMS-986278

BMS-986278 Placebo

Placebo Comparator group

Treatment:

Drug: BMS-986278 Placebo