A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic 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 2023-503697-21-01
- Record updated
- 2026. szeptember 30.
- Original description
To evaluate the efficacy of admilparant compared to placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52.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 Idiopathic Pulmonary Fibrosis
To evaluate the efficacy of admilparant compared to placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52.
Inclusion: Subjects with IPF aged ≥ 40 years at the time of signing the informed consent; Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia; 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; 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; 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; Interstitial Lung Disease (ILD) associated with known primary causes (eg.hypersensitivity pneumonitis,autoimmune associated ILD,sarcoidosis,etc.).