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
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Signed informed consent
• Men or women between 18 and 80 years of age, inclusively
• Documented initial biopsy-proven diagnosis of celiac disease or, in case of missing histological documentation, TG2-IgA \> 10 x upper limit of normal (ULN) at diagnosis at least 12 months prior to V0
• Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0
• Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
Locations
Other Locations
Germany
University Medical Center Mainz
RECRUITING
Mainz
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2027-08
Participants
Target number of participants: 356
Treatments
Experimental: low Dose 1 ZED1227 + SIGE
Placebo_comparator: Placebo + SIGE
Experimental: medium Dose ZED1227 + SIGE
Experimental: high dose ZED1227 + SIGE
Experimental: low Dose 2 ZED1227 + SIGE
Related Therapeutic Areas
Sponsors
Collaborators: Takeda Development Center Americas, Inc.
Leads: Dr. Falk Pharma GmbH