Celiac Disease
Conditions
Keywords
Celiac Disease, non-responsive Celiac Disease
Brief summary
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
Interventions
DRUGZED1227 + SIGE
oral treatment with different daily doses of ZED1227 vs placebo
OTHERPlacebo
Placebo + SIGE
Sponsors
Dr. Falk Pharma GmbH
Takeda Development Center Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CDSD GI Specific Symptom Score | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in PRO: Change from baseline in the percentage of Symptom Free Days (SFD) | V5 (Wk 15) over a 14-day period |
| Histological assessment of villous height to crypt depth ratio (VH:CrD) | 15 weeks |
| Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea) | 12 weeks |
| Proportion of subjects with histologic non-worsening, defined as change in VH:CrD ≥ 0 | 15 weeks |
| Change in duodenal mucosal inflammation measured as the density of CD3positive intraepithelial lymphocytes (IELs) | 15 weeks |
| Change in serological markers TG2-IgA, TG2-IgG, DGP-IgA, DGP-IgG, and EmA-IgA | 12 weeks |
Countries
Germany
Outcome results
None listed