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Evaluating a new treatment for progressive pulmonary fibrosis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

PHASE3 · Bristol-Myers Squibb · NCT06025578

This study is testing a new medication called BMS-986278 to see if it can help people with progressive pulmonary fibrosis feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1092 (estimated)
Ages21 Years and up
SexAll
SponsorBristol-Myers Squibb (industry)
Drugs / interventionstofacitinib, upadacitinib, Methotrexate, prednisone
Locations532 sites (Birmingham, Alabama and 531 other locations)
Trial IDNCT06025578 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of a medication called BMS-986278 in patients diagnosed with progressive pulmonary fibrosis. Participants will be monitored for their response to the treatment compared to a placebo. The study will include individuals who have been diagnosed with interstitial lung disease and have specific criteria regarding their previous treatments. The goal is to determine if BMS-986278 can provide a beneficial effect in managing this condition.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with interstitial lung disease exhibiting progressive features and fibrosis as confirmed by imaging.

Not a fit: Patients who have not been diagnosed with progressive pulmonary fibrosis or those who have recently changed their medication regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the management and outcomes for patients with progressive pulmonary fibrosis.

How similar studies have performed: Other studies have explored treatments for pulmonary fibrosis, but the specific approach of using BMS-986278 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Birmingham, Alabama and 531 other locations

+482 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Progressive Pulmonary Fibrosis, BMS-986278, LPA1 antagonist, Pulmonary fibrosis, Interstitial lung disease, Rheumatoid Arthritis, Connective Tissue Disorders, Sarcoidosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.