A study on people with systemic sclerosis to assess whether BI 685509 has an effect on lung function and other symptoms of systemic sclerosis
Résumé de l'étude
Currently, there are no disease-modifying therapies that address the underlying pathophysiology of systemic sclerosis (systemic sclerosis, SSc). BI 685509 is intended to target the underlying fibrosis and vascularopathy that cause the manifestations of early progressive diffuse cutaneous systemic sclerosis (progressive diffuse cutaneous systemic sclerosis, dcSSc), as well as changes associated with the further course of the disease. The results of the study will inform the further development of BI 685509 and future study designs.
(BASEC)
Intervention étudiée
The aim of the study is to evaluate the efficacy, safety, and tolerability of BI 685509 compared to placebo against a background of local standard therapy (standard of care, SOC) in treating adult patients with early progressive dcSSc and vascularopathy.
(BASEC)
Maladie en cours d'investigation
Early progressive diffuse cutaneous systemic sclerosis
(BASEC)
1. Signed and dated written patient information and informed consent according to ICH-GCP and local legislation prior to enrollment in the study. 2. Male or female patients aged ≥ 18 years at the time of consent (or above the legal age, e.g., UK ≥ 16 years). 3. Patients must meet the ACR/EULAR classification criteria for SSc from 2013. (BASEC)
Critères d'exclusion
1. Any known form of pulmonary hypertension. 2. Limited cutaneous SSc at screening. Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy, and secondary Sjögren's syndrome. 3. Diffusing capacity for carbon monoxide (DLCO) (hemoglobin-corrected) < 40 % of predicted at screening. (BASEC)
Lieu de l’étude
St-Gall, Zurich
(BASEC)
Sponsor
Boehringer Ingelheim International GmbH
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med.Oliver Distler
+41 79 882 96 93
lucia.fleckenstein@clutterusz.chUniversity Hospital Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
10.03.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
A Phase II, randomised, placebo-controlled, double-blind, parallel‑group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with progressive systemic sclerosis (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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