A clinical study to assess the efficacy, safety, and tolerability of BMS-986278 in participants with idiopathic pulmonary fibrosis
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
History of stroke or ischemic attack within 3 months prior to the study; Significant heart disease within 6 months prior to the study (BASEC)
Luogo dello studio
Basilea, Berna
(BASEC)
Sponsor
Bristol-Myers Squibb SA, Hinterbergstrasse 16, CH-6312 Steinhausen
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. Katrin Hostettler Haack
+41 61 265 25 25
Katrin.Hostettler@clutterusb.chUniversitätsspital Basel, Pneumologie, Petersgraben 4, 4031 Basel
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
31.08.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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