NCT07298343

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for phase_2

Timeline
15mo left

Started Jun 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jun 2024Aug 2027

Study Start

First participant enrolled

June 10, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

December 17, 2025

Last Update Submit

April 1, 2026

Conditions

Celiac Disease

Keywords

Celiac Diseasenon-responsive Celiac Disease

Outcome Measures

Primary Outcomes (1)

  • Change in CDSD GI Specific Symptom Score

    12 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (5)

low Dose 1 ZED1227 + SIGE

EXPERIMENTAL
Drug: ZED1227 + SIGE

Placebo + SIGE

PLACEBO COMPARATOR
Other: Placebo

medium Dose ZED1227 + SIGE

EXPERIMENTAL
Drug: ZED1227 + SIGE

high dose ZED1227 + SIGE

EXPERIMENTAL
Drug: ZED1227 + SIGE

low Dose 2 ZED1227 + SIGE

EXPERIMENTAL
Drug: ZED1227 + SIGE

Interventions

ZED1227 + SIGEDRUG

oral treatment with different daily doses of ZED1227 vs placebo

high dose ZED1227 + SIGElow Dose 1 ZED1227 + SIGElow Dose 2 ZED1227 + SIGEmedium Dose ZED1227 + SIGE
PlaceboOTHER

Placebo + SIGE

Placebo + SIGE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of hypo- or hyperthyroidism. A patient with a well-controlled thyroid disorder during the previous 3 months can be included
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Mainz

Mainz, Germany

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Interventions

ZED1227

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 23, 2025

Study Start

June 10, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 2, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)