A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis
Key facts
- Where
- Budapest Viii és Győr, MagyarországSee the 2 sites
- Phase
- 3. fázis
Where in Magyarország
- Clinic Of Pulmonology Semmelweis UniversityBudapest Viii, MagyarországNo longer taking part
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazGyőr, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb Services Unlimited Company
- Trial code
- EU 2023-503699-25-00
- Record updated
- 2026. szeptember 30.
- Original description
To evaluate the efficacy of 2 doses of admilparant compared with placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52 in participants with PPF.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis
To evaluate the efficacy of 2 doses of admilparant compared with placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52 in participants with PPF.
Inclusion: Subjects ≥ 21 years at the time of signing the informed consent; 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 at screening and predose; Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
Exclusion: History of stroke or transient ischemic attack within 3 months prior to screening; Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study; Exhibit symptoms of heart failure at rest; Participants who have: 1) a current malignancy, 2) a previous malignancy with less than 2 years free of recurrence, 3) a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be ruled out; Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.