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Clinical Trials in India / NCT06025578
Active, not recruiting Phase 3

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

NCT06025578 · tracked via the Priya Life Science India tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2023-10-25
Last updated
2026-04-23

Condition(s) studied

Progressive Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

BMS-986278BMS-986278 Placebo

BMS-986278: Specified dose on specified days

BMS-986278 Placebo: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
21 Years
Max age
Healthy volunteers
No
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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (459)

FacilityCityRegionStatus
Local Institution - 0046 Birmingham Alabama
Local Institution - 0314 Phoenix Arizona
Local Institution - 0336 La Jolla California
Local Institution - 0212 Los Angeles California
Local Institution - 0019 Los Angeles California
Local Institution - 0535 Newport Beach California
Local Institution - 0366 Orange California
Local Institution - 0341 Sacramento California
Local Institution - 0015 San Francisco California
Local Institution - 0352 Stanford California
Local Institution - 0321 Aurora Colorado
Local Institution - 0376 Denver Colorado
Local Institution - 0211 New Haven Connecticut
Local Institution - 0418 Stamford Connecticut
Local Institution - 0067 Newark Delaware
Local Institution - 0354 Washington D.C. District of Columbia
Local Institution - 0195 Brandon Florida
Local Institution - 0380 Celebration Florida
Local Institution - 0013 Clearwater Florida
Local Institution - 0396 DeBary Florida
Local Institution - 0036 Gainesville Florida
Local Institution - 0193 Gainesville Florida
Local Institution - 0073 Loxahatchee Groves Florida
Local Institution - 0220 Ocala Florida
Local Institution - 0452 Pensacola Florida
Local Institution - 0389 St. Petersburg Florida
Local Institution - 0316 Tampa Florida
Local Institution - 0070 Atlanta Georgia
Local Institution - 0368 Dublin Georgia
Local Institution - 0435 Chicago Illinois
Local Institution - 0023 Chicago Illinois
Local Institution - 0040 Evanston Illinois
Local Institution - 0082 Maywood Illinois
Local Institution - 0080 Iowa City Iowa
Local Institution - 0049 Kansas City Kansas
Local Institution - 0045 Louisville Kentucky
Local Institution - 0361 Louisville Kentucky
Local Institution - 0305 Baltimore Maryland
Local Institution - 0033 Towson Maryland
Local Institution - 0404 Boston Massachusetts

+ 419 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06025578 on ClinicalTrials.gov ↗ ← All trials in India