A study on people with systemic sclerosis to assess whether BI 685509 has an effect on lung function and other symptoms of systemic sclerosis
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
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)
Trial sites
St. Gallen, Zurich
(BASEC)
Sponsor
Boehringer Ingelheim International GmbH
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med.Oliver Distler
+41 79 882 96 93
lucia.fleckenstein@clutterusz.chUniversity Hospital Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
10.03.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available