ZED1227 for treatment of symptomatic celiac disease subjects
Research type
Research Study
Full title
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.
IRAS ID
1008894
Contact name
Beate Niemeier
Contact email
Sponsor organisation
Dr. Falk Pharma GmbH
Eudract number
2023-506150-21
ISRCTN Number
ISRCTN79155276
Research summary
This clinical trial is investigating if the study drug, ZED1227, can help reduce the symptoms and the damage to the cells in the intestine caused when coeliac disease suffers eat gluten. The safety and tolerability of the study drug will also be monitored.
ZED1227 is a newly developed inhibitor of transglutaminase 2 (TG2). TG2 is a protein found in the small intestine and plays an important role in making you feel sick after eating gluten. TG2 has a role in activating certain immune cells that recognise gluten as a foreign substance and cause damage to your gut while attempting to clear the gluten. In certain individuals at risk for coeliac disease, blocking the activity of TG2 may prevent the activation of these immune cells, helping to prevent the gluten-induced reaction contributing to celiac disease symptoms.
Patients from 18-80 yrs old, from all around the world, who have had coeliac disease for at least 12 months and, despite being on a gluten-free diet for at least 12 months, still experience symptoms, will be invited to take part in the study.
The study will involve taking the study drug 3 times a day with a meal and eating a gluten containing snack bar 3 times a week (this mimics unintended gluten exposure, which may happen in everyday life). The overall duration of study participation will be about 23 weeks and will require the participant to attend 7 visits at the study site. At these visits the participant will have various procedures performed including collection of blood and urine samples, they will be required to complete study questionnaires and discuss their medication and health. Two gastrointestinal endoscopies with biopsies will be required; one at the start of the study and another at the end. For the duration of the study the participants will be asked to complete an electronic diary, recording, for example: when they took their medication, their coeliac symptoms and other health issues experienced.
REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0071
Date of REC Opinion
1 Mar 2024
REC opinion
Further Information Favourable Opinion