Last updated 2 days ago
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
1092 patients around the world
Available in Spain, Colombia, United States, Chile, Peru, Brazil, Argentina, Mexico
Bristol-Myers Squibb
1092Patients around the world
This study is for people with
Pulmonary fibrosis
Requirements for the patient
From 21 Years
All Gender
Medical requirements
- Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of disease 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), 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. Systemic corticosteroids are permitted provided that the participant is on prednisone ≤ 15 mg/day or equivalent for at least 70 days prior to Day 1. 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
- Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screeningHistory of stroke or transient ischemic attack within 3 months prior to screeningSignificant cardiac disease within 6 months prior to screening per the investigator's discretionParticipants 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.
SponsorBristol-Myers Squibb
Conditions
Pulmonary fibrosis
Requirements
From 21 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06025578
