Active, Not Recruiting

Trial ID IM027-1015 | NCT06025578

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

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About This Trial
Key Eligibility Criteria

Summary

Phase 3
21+

Age Range
Active, Not Recruiting

Overview

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

Key Eligibility 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; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.

Additional Information *

Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: BMS-986278 Dose 1

ASSIGNED INTERVENTION

Drug: BMS-986278

Study Arms

Experimental: BMS-986278 Dose 2

ASSIGNED INTERVENTION

Drug: BMS-986278

Study Arms

Placebo Comparator: BMS-986278 Placebo

ASSIGNED INTERVENTION

Drug: BMS-986278 Placebo

Trial ID IM027-1015 | NCT06025578

Summary

Overview

Key Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Treatment Options

Study Arms

ASSIGNED INTERVENTION

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