Actively Recruiting
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
Led by Dr. Falk Pharma GmbH · Updated on 2026-04-02
356
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of ZED1227 in people with celiac disease who continue to experience symptoms despite following a gluten-free diet. This Phase II, double-blind, randomized, placebo-controlled trial aims to assess both the effectiveness and tolerability of the treatment. The study is sponsored by Dr. Falk Pharma GmbH and focuses on improving gastrointestinal symptoms related to celiac disease. Participants will receive oral treatment with varying daily doses of ZED1227 combined with SIGE or a placebo with SIGE. The trial includes several groups receiving low, medium, or high doses of ZED1227 or placebo, and the treatment period lasts at least 12 weeks. The design ensures participants and researchers do not know who receives the active drug or placebo to fairly compare results. During the study, participants will undergo symptom assessments using the CDSD GI Specific Symptom Score, evaluation of symptom-free days, and histological examinations of intestinal tissue. Blood tests will monitor serological markers related to celiac disease. Researchers will also track any changes in intestinal inflammation and safety. The trial will continue until August 2027, allowing careful monitoring of outcomes and side effects throughout the study period.
CONDITIONS
Brief 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 documentation, 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 to study start
- Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
You will not qualify if you...
- Presence of hypo- or hyperthyroidism unless well-controlled during the previous 3 months
- Confirmed refractory celiac disease type I or II, except some RCDI cases without severe symptoms or prior immunosuppressant treatment
- Severe complications of celiac disease
- Other intestinal diseases such as Crohn's disease, ulcerative colitis, severe irritable bowel syndrome, microscopic colitis, SIBO, exocrine pancreatic insufficiency, and other active intestinal conditions
- History or presence of dermatitis herpetiformis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral treatment with different daily doses of ZED1227 or placebo alongside SIGE to evaluate efficacy and tolerability.
Weekly visits for up to 12 weeks
Duration - 3 weeks
Participants undergo assessments including histological and serological evaluations after treatment ends.
1 visit at Week 15
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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