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

Progressive Pulmonary Fibrosis

The 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 Hospital
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Christopher Ryerson, Site 0462

604682234468665
Local Institution - 0385
Local Institution - 0385
Edmonton, Alberta
Canada

Contact Study Team

Inspiration Research
Inspiration Research
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Kenneth Chapman, Site 0106

4169449602
C.I.C. Mauricie Inc.
C.I.C. Mauricie Inc.
Trois-Rivieres, Quebec
Canada

Contact Study Team

Primary Contact

Emilie Millaire, Site 0074

8193731128
The Lung Centre
The Lung Centre
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Nasreen Khalil, Site 0107

6048754122
Local Institution - 0075
Local Institution - 0075
Owen Sound, Ontario
Canada

Contact Study Team

Primary Contact

Site 0075

Local Institution - 0099
Local Institution - 0099
Sherbrooke, Quebec
Canada

Contact Study Team

Primary Contact

Site 0099

Local Institution - 0053
Local Institution - 0053
Burlington, Ontario
Canada

Contact Study Team

Primary Contact

Site 0053

Synergy Respiratory & Cardiac Care
Synergy Respiratory & Cardiac Care
Sherwood Park, Alberta
Canada

Contact Study Team

Primary Contact

Dina Fathy, Site 0108

(780) 800-6906
Centre Hospitalier de l'Université de Montréal (CHUM)
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Helene Manganas, Site 0440

5148908000
Local Institution - 0492
Local Institution - 0492
Trois-Rivieres, Quebec
Canada

Contact Study Team

Primary Contact

Site 0492

Local Institution - 0097
Local Institution - 0097
Kelowna, British Columbia
Canada

Contact Study Team

Primary Contact

Site 0097

St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Martin Kolb, Site 0111

9055216130
Local Institution - 0514
Local Institution - 0514
Saint-Charles-Borromee, Quebec
Canada

Contact Study Team

Primary Contact

Site 0514

Local Institution - 0529
Local Institution - 0529
Greenfield Park, Quebec
Canada

Contact Study Team

Primary Contact

Site 0529

Study Sponsored By
Bristol-Myers Squibb
Participants Required
More Information
Study ID: NCT06025578