> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluating-the-efficacy-and-tolerability-of-zed1227-in-cdc47843-663c-419e-a310-389decbb77c2 > Record changed: 2026-10-13 # Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease NCT07298343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) Participants 356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) Lead sponsor Dr. Falk Pharma GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) Start date 2024-06-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Title and summary **Summary** A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Acronym** CEC-013/CEL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Short title** Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Dates **Completion date** 2027-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **First posted** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Registry last updated** 2026-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Primary completion date** 2027-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Start date** 2024-06-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Size and sites **Participants** 356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Planned participants** 356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Lead sponsor** Dr. Falk Pharma GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Identifiers **Registry ID** NCT07298343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **ClinicalTrials.gov ID** NCT07298343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Outcomes ### Primary outcomes 1. Change in CDSD GI Specific Symptom Score Timeframe: 12 weeks ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Sites - University Medical Center MainzMainz, GermanyRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## References ### Other registry identifiers (2) - 2023 - 2023-506150-21 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07298343) ## Related records ### Drugs (1) - [ZED-1227](https://trialight.com/data/asset/zed-1227-aa36cf7a-0338-4f02-8836-5cf643b0023a.md) ### Collaborators (1) - Takeda Development Center Americas, Inc. ### Lead sponsors (1) - [Dr. Falk Pharma GmbH](https://trialight.com/data/company/dr-falk-pharma-gmbh-ec7b98c8-3644-445f-9367-3d1c6d3f8acd.md) ### Conditions (1) - [Celiac disease](https://trialight.com/data/condition/celiac-disease-4cbc090d-ae58-587f-a833-9f3b17bc0ea0.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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