BMS 1015
Study on Investigational Treatment for Progressive Pulmonary Fibrosis
Brief description of study
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Progressive Pulmonary Fibrosis
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Age: 21 years or above
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Gender: All
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.
This study investigates Progressive Pulmonary Fibrosis. The study focuses on understanding how the investigational medication works for this condition.
This study evaluates the safety, effectiveness, and tolerability of the investigational medication. It looks into how well participants respond to the treatment.
- Who can participate: Adults diagnosed with interstitial lung disease (ILD) showing progressive features within the last 24 months may be eligible. Participants must have at least 10% fibrosis on a specific lung scan and meet medication stability requirements.
- Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
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