EUCTR2020-004612-97-DE
Active, not recruiting
Phase 1
A phase IIb, 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
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment of celiac disease
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
- •At least one moderate or severe gastrointestinal symptom (i.e., diarrhoea, abdominal pain, bloating or nausea) during the last 4 weeks prior to Baseline Visit A, Visit 2, and Baseline Visit B
- •Negative diagnosis of Helicobacter pylori infection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Presence of hypo\- or hyperthyroidism
- •Subjects 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 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 \[e.g., enteropathy associated Tcell lymphoma (EATL), ulcerative jejunitis, perforation],
- •Concomitant diseases of the intestinal tract in addition to celiac disease that might, in the investigator's opinion, interfere with
- •assessment of symptoms of abdominal pain, diarrhoea, or other components of celiac disease
- •Evidence of relevant systemic disease
Outcomes
Primary Outcomes
Not specified
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