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

NCT ID: NCT07298343

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2027-08-31

Brief Summary

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

Detailed Description

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Conditions

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Celiac Disease

Keywords

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Celiac Disease non-responsive Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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low Dose 1 ZED1227 + SIGE

Group Type EXPERIMENTAL

ZED1227 + SIGE

Intervention Type DRUG

oral treatment with different daily doses of ZED1227 vs placebo

Placebo + SIGE

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo + SIGE

medium Dose ZED1227 + SIGE

Group Type EXPERIMENTAL

ZED1227 + SIGE

Intervention Type DRUG

oral treatment with different daily doses of ZED1227 vs placebo

high dose ZED1227 + SIGE

Group Type EXPERIMENTAL

ZED1227 + SIGE

Intervention Type DRUG

oral treatment with different daily doses of ZED1227 vs placebo

low Dose 2 ZED1227 + SIGE

Group Type EXPERIMENTAL

ZED1227 + SIGE

Intervention Type DRUG

oral treatment with different daily doses of ZED1227 vs placebo

Interventions

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ZED1227 + SIGE

oral treatment with different daily doses of ZED1227 vs placebo

Intervention Type DRUG

Placebo

Placebo + SIGE

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role collaborator

Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Mainz

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2023-506150-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CEC-013/CEL

Identifier Type: -

Identifier Source: org_study_id