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Recruiting NCT07298343

Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease

Phase II Interventional Celiac Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZED1227 + SIGE, Placebo.
Who it may be relevant to
Registry conditions: Celiac Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet

Interventions

  • Drug ZED1227 + SIGE
    oral treatment with different daily doses of ZED1227 vs placebo
  • Other Placebo
    Placebo + SIGE

Primary outcome measures

  • Change in CDSD GI Specific Symptom Score [Time frame: 12 weeks]
Secondary outcome measures (6)
  • Change in PRO: Change from baseline in the percentage of Symptom Free Days (SFD) [Time frame: V5 (Wk 15) over a 14-day period]
  • Histological assessment of villous height to crypt depth ratio (VH:CrD) [Time frame: 15 weeks]
  • Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea) [Time frame: 12 weeks]
  • Proportion of subjects with histologic non-worsening, defined as change in VH:CrD ≥ 0 [Time frame: 15 weeks]
  • Change in duodenal mucosal inflammation measured as the density of CD3positive intraepithelial lymphocytes (IELs) [Time frame: 15 weeks]
  • Change in serological markers TG2-IgA, TG2-IgG, DGP-IgA, DGP-IgG, and EmA-IgA [Time frame: 12 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Medical Center Mainz — Mainz

Identifiers

NCT: NCT07298343 · CEC-013/CEL · 2023-506150-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗