NCT07298343Active, not recruitingPhase 2
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 356
- Locations
- 1
- Primary Endpoint
- Change in CDSD GI Specific Symptom Score
Study Overview
Brief Summary
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
low Dose 1 ZED1227 + SIGE
Experimental
Intervention: ZED1227 + SIGE (Drug)
Placebo + SIGE
Placebo Comparator
Intervention: Placebo (Other)
medium Dose ZED1227 + SIGE
Experimental
Intervention: ZED1227 + SIGE (Drug)
high dose ZED1227 + SIGE
Experimental
Intervention: ZED1227 + SIGE (Drug)
low Dose 2 ZED1227 + SIGE
Experimental
Intervention: ZED1227 + SIGE (Drug)
Outcomes
Primary Outcomes
Change in CDSD GI Specific Symptom Score
Time Frame: 12 weeks
Secondary Outcomes
- 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)
- Change in duodenal mucosal inflammation measured as the density of CD3positive intraepithelial lymphocytes (IELs)(15 weeks)
- Proportion of subjects with histologic non-worsening, defined as change in VH:CrD ≥ 0(15 weeks)
- Change in serological markers TG2-IgA, TG2-IgG, DGP-IgA, DGP-IgG, and EmA-IgA(12 weeks)
Investigators
Study Sites (1)
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