Actively Recruiting
Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease
Led by Dr. Falk Pharma GmbH · Updated on 2026-04-02
356
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
D
Dr. Falk Pharma GmbH
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
CONDITIONS
Official Title
Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Men or women between 18 and 80 years of age, inclusively
- Documented initial biopsy-proven diagnosis of celiac disease or, if no biopsy, TG2-IgA > 10 x upper limit of normal at diagnosis at least 12 months prior
- Adherence to a gluten-free diet for at least 12 months prior
- Human leukocyte antigen DQ typing compatible with celiac disease
You will not qualify if you...
- Presence of hypo- or hyperthyroidism unless well controlled for the previous 3 months
- Confirmed refractory celiac disease type I or II, except type I without signs of T cell monoclonality or atypical T cells, no severe symptoms, and no prior immunosuppressant treatment
- Severe complications of celiac disease
- Other intestinal diseases such as Crohn's, ulcerative colitis, severe IBS, microscopic colitis, SIBO, exocrine pancreatic insufficiency, or other active intestinal diseases interfering with symptom assessment
- History or presence of dermatitis herpetiformis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Medical Center Mainz
Mainz, Germany
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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