Taking peoplePhase 3
Tests admilparant in adults with progressive pulmonary fibrosis
Tests admilparant against placebo in adults with progressive lung scarring.
Key facts
- Who runs it
- Bristol-Myers Squibb Services Unlimited Company
- Where
- Ancona, Bergamo, Florence, Foggia, Forli', Milan, Modena, Monza, Napoli, Palermo, Pavia, Pisa, Rome, Sassari, and Siena, ItalySee the 16 sitesAlso in 14 other countries, 83 sites
- Trial code
- EU 2023-503699-25-00
- U1111-1287-7539
- Registry title
- A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 249 people, planned
- Started
- 15 Jul 2024
- Expected to end
- 22 Dec 2027
- Type of study
- Interventional
- Record updated
- 30 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with progressive pulmonary fibrosis (scarring of the lungs that keeps getting worse). It tests a drug called BMS-986278 (admilparant) against a placebo.
- Age
- 21 years or older (the registry also lists a minimum age of 18 years).
- Sex
- All sexes can join.
- Disease stage
- Interstitial lung disease with signs that it is getting worse, diagnosed within 24 months before screening. A screening lung scan (HRCT) must show 10% or more fibrosis.
- Earlier treatment
- If taking pirfenidone or nintedanib, the dose must have been stable for at least 90 days. If not taking them, none in the last 28 days. Some other drugs (MMF, mycophenolic acid, azathioprine, tacrolimus, DMARDs, JAK inhibitors) are allowed on a stable dose for 90 days, or not taken in the last 28 days.
Main reasons for not taking part
- Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) confirmed at screening
- Stroke or transient ischemic attack in the last 3 months
- Heart failure symptoms at rest
- Current cancer, or cancer in the last 2 years, or a biopsy that may show cancer
- Steroid tablets above 15 mg/day of prednisone in the last 4 weeks
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 14 other countries, 83 sites
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyNo longer taking part
- Azienda Ospedaliera Papa Giovanni XXIIIBergamo, ItalyNo longer taking part
- Careggi University HospitalFlorence, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria Ospedali Riuniti-Policlinico di Foggia-Ospedale C. D'AvanzoFoggia, ItalyNo longer taking part
- Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di ForlìForli', ItalyNo longer taking part
- Azienda Sociosanitaria Territoriale Santi Paolo E CarloMilan, ItalyNo longer taking part
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNo longer taking part
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyNo longer taking part
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyNo longer taking part
- Azienda Ospedaliera Dei Colli-Ospedale Colli MonaldiNapoli, ItalyNo longer taking part
- Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.Palermo, ItalyNo longer taking part
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria di SassariSassari, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria SeneseSiena, ItalyNo longer taking part
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests admilparant in adults with progressive pulmonary fibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 30 September 2026