A study to find out whether symptoms of celiac disease that persist despite a gluten-free diet can be improved with the study drug ZED1227
Summary description of the study
In the study, participants are randomly assigned (like flipping a coin) to treatment with ZED1227 or placebo. The placebo looks like ZED1227 but contains no active ingredient. While participants take ZED1227 or placebo, they consume a snack bar containing a small amount of gluten three times a week (much less than is found in a slice of bread). The researchers want to investigate whether the drug helps even when patients inadvertently consume gluten through their normal diet. The consumption of these snack bars is referred to as simulated inadvertent gluten exposure (SIGE). The comparison between the patient group treated with ZED1227 and the placebo group will help researchers determine whether ZED1227 can alleviate the symptoms of celiac disease.
(BASEC)
Intervention under investigation
Efficacy of ZED1227 capsules for the treatment of celiac disease Endoscopy During this endoscopy, a biopsy is also performed, during which a small tissue sample is taken.
(BASEC)
Disease under investigation
Celiac disease
(BASEC)
This study includes adult patients with celiac disease aged 18 to 80 years who meet the following main criteria for participation: - Participants have been diagnosed with celiac disease in the past, confirmed by biopsy or blood test. - They have attempted to maintain a gluten-free diet for at least one year prior to the study. - They continue to experience symptoms and intestinal damage despite the gluten-free diet. (BASEC)
Exclusion criteria
Study participants cannot participate if they have other gastrointestinal diseases, severe food allergies, or signs of severe liver or kidney disease. (BASEC)
Trial sites
Bern, Zurich
(BASEC)
Sponsor
Dr. Falk Pharma GmbH, Freiburg im Breisgau / Deutschland
(BASEC)
Contact
Contact Person Switzerland
PD Dr. med. Jonas Zeitz
+44 3872 3955
Jonas.Zeitz@cluttergastrozentrum.chGastroZentrum Hirslanden, Witellikerstrasse 40, CH-8008 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
09.08.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A phase II, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet (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
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