ZED1227 for people with ongoing celiac symptoms despite a gluten-free diet

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial comparing ZED1227 plus SIGE to placebo in adults with non-responsive celiac disease. Eligible participants have prior biopsy-proven celiac disease (or very high TG2-IgA at diagnosis), HLA-DQ compatible typing, and have followed a gluten-free diet for at least 12 months. Participants receive the investigational treatment or placebo and are monitored for tolerability, symptom changes, and disease markers over the study period. The trial is sponsored by Dr. Falk Pharma GmbH with collaboration from Takeda and conducted at University Medical Center Mainz.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of hypo- or hyperthyroidism. A patient with a well-controlled thyroid disorder during the previous 3 months can be included
* Patients diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of T cell monoclonality or atypical T cells (e.g., as revealed by CD3/CD8 immunohistochemistry) and if they do not present with very severe symptoms and/or parameters of significant malabsorption and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine,
* Severe complications of celiac disease
* Concomitant diseases of the intestinal tract in addition to celiac disease, such as Crohn's disease, ulcerative colitis, other forms of inflammatory bowel disease, severe irritable bowel syndrome, microscopic colitis, small intestinal bacterial overgrowth (SIBO), exocrine pancreatic insufficiency; any other active diseases of the intestinal tract (e.g., active, untreated peptic ulcer, esophagitis, gastroesophageal reflux disease) that might, in the investigator's opinion, interfere with assessment of symptoms of abdominal pain, diarrhoea, or other components of celiac disease
* History or presence of dermatitis herpetiformis

Where it's running

• University Medical Center Mainz
  Mainz, Germany Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.