Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease (CEC-013/CEL)

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

A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet

Study Overview

• Status: Recruiting
• Conditions: Celiac Disease
• Intervention / Treatment: Drug: ZED1227 + SIGE; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 356
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany
    • Recruiting
    • University Medical Center Mainz
    • Contact: Detlef Schuppan, Professor; Phone Number: 7356 +49 (6131) 17-0; Email: detlef.schuppan@unimedizin-mainz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low Dose 1 ZED1227 + SIGE	Drug: ZED1227 + SIGE; oral treatment with different daily doses of ZED1227 vs placebo
Placebo Comparator: Placebo + SIGE	Other: Placebo; Placebo + SIGE
Experimental: medium Dose ZED1227 + SIGE	Drug: ZED1227 + SIGE; oral treatment with different daily doses of ZED1227 vs placebo
Experimental: high dose ZED1227 + SIGE	Drug: ZED1227 + SIGE; oral treatment with different daily doses of ZED1227 vs placebo
Experimental: low Dose 2 ZED1227 + SIGE	Drug: ZED1227 + SIGE; oral treatment with different daily doses of ZED1227 vs placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in CDSD GI Specific Symptom Score	12 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Dr. Falk Pharma GmbH
• Collaborators: Takeda Development Center Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Celiac Disease; non-responsive Celiac Disease
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease; ZED1227
• Other Study ID Numbers: CEC-013/CEL; 2023-506150-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No