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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Progressive Pulmonary Fibrosis

In brief

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

Key facts

Study ID

NCT06025578

Run by

Bristol-Myers Squibb

People needed

1057

Starts

2023-10-25

Expected to finish

2027-12-27

Last updated by the study team

2026-04-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0323 — Shenyang, Liaoning, China
• Local Institution - 0497 — Shenyang, Liaoning, China
• Local Institution - 0311 — Xi'an, Shan3xi, China
• Local Institution - 0329 — Shanghai, Shanghai Municipality, China
• Local Institution - 0386 — Shanghai, Shanghai Municipality, China
• Local Institution - 0096 — Shanghai, Shanghai Municipality, China
• Local Institution - 0098 — Shanghai Shi, Shanghai Municipality, China
• Local Institution - 0083 — Shanghai Shi, Shanghai Sheng, China
• Local Institution - 0088 — Shanghai, SH, China
• Local Institution - 0324 — Shanghai, SH, China
• Local Institution - 0318 — Chengdu, Sichuan, China
• Local Institution - 0372 — Tianjin, Tianjin Municipality, China
• Local Institution - 0326 — Tianjin, TJ, China
• Local Institution - 0454 — Ningxia, Yinchuan, China
• Local Institution - 0508 — Hangzhou, Zhejiang, China
• Local Institution - 0319 — Hangzhou, Zhejiang, China
• Local Institution - 0298 — Ningbo, Zhejiang, China
• Local Institution - 0429 — Hangzhou, ZJ, China
• Local Institution - 0426 — Changsha, China
• Local Institution - 0313 — Chengdu, China
• Local Institution - 0084 — Hefei, China
• Local Institution - 0105 — Hohhot, China
• Local Institution - 0433 — Jinan, China
• Local Institution - 0434 — Shijiazhuang, China
• Local Institution - 0443 — Nanchang, JX, China

Full record on ClinicalTrials.gov

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