A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
Progressive Pulmonary FibrosisThe purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
21 and up
Participation 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.
Study Location
St. Paul's Hospital
St. Paul's HospitalVancouver, British Columbia
Canada
Contact Study Team
Christopher Ryerson, Site 0462
604682234468665Local Institution - 0385
Local Institution - 0385Edmonton, Alberta
Canada
Contact Study Team
Inspiration Research
Inspiration ResearchToronto, Ontario
Canada
Contact Study Team
Kenneth Chapman, Site 0106
4169449602C.I.C. Mauricie Inc.
C.I.C. Mauricie Inc.Trois-Rivieres, Quebec
Canada
Contact Study Team
Emilie Millaire, Site 0074
8193731128The Lung Centre
The Lung CentreVancouver, British Columbia
Canada
Contact Study Team
Nasreen Khalil, Site 0107
6048754122Local Institution - 0075
Local Institution - 0075Owen Sound, Ontario
Canada
Contact Study Team
Site 0075
Local Institution - 0099
Local Institution - 0099Sherbrooke, Quebec
Canada
Contact Study Team
Site 0099
Local Institution - 0053
Local Institution - 0053Burlington, Ontario
Canada
Contact Study Team
Site 0053
Synergy Respiratory & Cardiac Care
Synergy Respiratory & Cardiac CareSherwood Park, Alberta
Canada
Contact Study Team
Dina Fathy, Site 0108
(780) 800-6906Centre Hospitalier de l'Université de Montréal (CHUM)
Centre Hospitalier de l'Université de Montréal (CHUM)Montreal, Quebec
Canada
Contact Study Team
Helene Manganas, Site 0440
5148908000Local Institution - 0492
Local Institution - 0492Trois-Rivieres, Quebec
Canada
Contact Study Team
Site 0492
Local Institution - 0097
Local Institution - 0097Kelowna, British Columbia
Canada
Contact Study Team
Site 0097
St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare HamiltonHamilton, Ontario
Canada
Contact Study Team
Martin Kolb, Site 0111
9055216130Local Institution - 0514
Local Institution - 0514Saint-Charles-Borromee, Quebec
Canada
Contact Study Team
Site 0514
Local Institution - 0529
Local Institution - 0529Greenfield Park, Quebec
Canada
Contact Study Team
Site 0529
- Study Sponsored By
- Bristol-Myers Squibb
- Participants Required
- More Information
- Study ID:
NCT06025578