A clinical study to assess the efficacy, safety, and tolerability of BMS-986278 in participants with idiopathic pulmonary fibrosis
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
History of stroke or ischemic attack within 3 months prior to the study; Significant heart disease within 6 months prior to the study (BASEC)
Studienstandort
Basel, Bern
(BASEC)
Sponsor
Bristol-Myers Squibb SA, Hinterbergstrasse 16, CH-6312 Steinhausen
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. Katrin Hostettler Haack
+41 61 265 25 25
Katrin.Hostettler@clutterusb.chUniversitätsspital Basel, Pneumologie, Petersgraben 4, 4031 Basel
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
31.08.2023
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar