ZED1227 for people with ongoing celiac symptoms despite a gluten-free diet
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
PHASE2 · Dr. Falk Pharma GmbH · NCT07298343
This trial will test whether ZED1227 can reduce persistent celiac disease symptoms in adults who still have problems despite following a gluten-free diet.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Dr. Falk Pharma GmbH (industry) |
| Locations | 1 site (Mainz) |
| Trial ID | NCT07298343 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with a prior biopsy-proven celiac diagnosis (or very high TG2-IgA at diagnosis), HLA-DQ compatible typing, and at least 12 months of adherence to a gluten-free diet who continue to have symptoms are ideal candidates.
Not a fit: Patients with confirmed refractory celiac disease type II or those with uncontrolled thyroid disease or symptoms clearly due to other causes are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, ZED1227 could reduce ongoing symptoms and help improve intestinal recovery for people whose celiac disease does not fully respond to a gluten-free diet.
How similar studies have performed: Early-phase work on ZED1227 and other transglutaminase-targeting approaches has shown promising safety and preliminary efficacy signals, but larger confirmatory data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mainz
- University Medical Center Mainz — Mainz, Germany (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Celiac Disease, non-responsive Celiac Disease