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

NCT07298343
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
356
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Lead sponsor
Dr. Falk Pharma GmbH
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Start date
2024-06-10
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Number of sites
1
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Summary
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
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Acronym
CEC-013/CEL
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Short title
Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-08-01
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First posted
2025-12-23
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Registry last updated
2026-04-02
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Primary completion date
2027-08-01
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Start date
2024-06-10
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Participants
356
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Participant count basis
Estimated
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Planned participants
356
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Protocol amendments
0
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Dr. Falk Pharma GmbH
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07298343
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ClinicalTrials.gov ID
NCT07298343
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. Change in CDSD GI Specific Symptom Score

    Timeframe: 12 weeks

  1. Change in PRO: Change from baseline in the percentage of Symptom Free Days (SFD)

    Timeframe: V5 (Wk 15) over a 14-day period

  2. Histological assessment of villous height to crypt depth ratio (VH:CrD)

    Timeframe: 15 weeks

  3. Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea)

    Timeframe: 12 weeks

  4. Proportion of subjects with histologic non-worsening, defined as change in VH:CrD ≥ 0

    Timeframe: 15 weeks

  5. Change in duodenal mucosal inflammation measured as the density of CD3positive intraepithelial lymphocytes (IELs)

    Timeframe: 15 weeks

  6. Change in serological markers TG2-IgA, TG2-IgG, DGP-IgA, DGP-IgG, and EmA-IgA

    Timeframe: 12 weeks

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • University Medical Center MainzMainz, GermanyRecruiting
Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506150-21
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)