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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Progressive Pulmonary Fibrosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06025578

IM027-1015

2023-503699-25 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 1,092 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
• 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.
• Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
• Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
• Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken 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

• Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
• 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 in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
• Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
• 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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1,092 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