A clinical study to assess the efficacy, safety, and tolerability of BMS-986278 in participants with idiopathic pulmonary fibrosis
Summary description of the study
In this clinical study, named IM027068, participants with IPF will be treated either with the study drug or with placebo twice daily. Neither you nor your study doctor knows which treatment you will receive. Participants may continue antifibrotic therapy for IPF with Nintedanib or Pirfenidone. The study consists of 2 parts: In Part 1, the first 60 participants with IPF will be enrolled so that a review committee can assess safety before Part 2 opens. In Part 2, the efficacy, safety, and tolerability of the study drug will be investigated in participants with IPF. Part 2 will include approximately 1125 participants. The study will last approximately 4 years in total.
(BASEC)
Intervention under investigation
The treatment period lasts from the visit date on Day 1 for the first participant until the end of treatment for the last participant, approximately 4 years (the individual study duration for a participant may range from at least 52 weeks to approximately 4 years, depending on when the last participant completes the visit at Week 52).
The study intervention consists of a blinded investigational product that is to be taken orally with liquid twice daily.
(BASEC)
Disease under investigation
There remains a significant unmet need for a safe, well-tolerated, and effective therapy for idiopathic pulmonary fibrosis (IPF) that improves lung function, delays disease progression, and reduces mortality. BMS-986278 is an orally administered investigational product being developed for the treatment of patients with IPF and progressive pulmonary fibrosis (PPF). A clinical study in participants with pulmonary fibrosis has shown favorable safety and efficacy with BMS-986278 as a monotherapy and in participants on antifibrotic treatment.
(BASEC)
Patients with IPF aged ≥ 40 years at the time of signing the informed consent; IPF diagnosis within the last 7 years; Participants on Pirfenidone or Nintedanib must have received a stable dose for at least 90 days; Participants who are currently not receiving either Pirfenidone or Nintedanib must not have received either of these two medications within 28 days prior to screening. (BASEC)
Exclusion criteria
History of stroke or ischemic attack within 3 months prior to the study; Significant heart disease within 6 months prior to the study (BASEC)
Trial sites
Basel, Bern
(BASEC)
Sponsor
Bristol-Myers Squibb SA, Hinterbergstrasse 16, CH-6312 Steinhausen
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. Katrin Hostettler Haack
+41 61 265 25 25
Katrin.Hostettler@clutterusb.chUniversitätsspital Basel, Pneumologie, Petersgraben 4, 4031 Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
31.08.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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 (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available