Celiac DiseasePhase 2CEC-013/CELNCT07298343
Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease
A Phase 2 study testing ZED1227 + SIGE in people with Celiac Disease, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- ZED1227 + SIGE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jun 2024to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Mainz
Mainz
Detlef Schuppan, Professor, +49 (6131) 17-0 ext. 7356, detlef.schuppan@unimedizin-mainz.de
About this study
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
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
- Conditions
- Celiac Disease
- Being tested
- ZED1227 + SIGE, Placebo
- Keywords
- Celiac Disease, non-responsive Celiac Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZED1227 + SIGEDrug
oral treatment with different daily doses of ZED1227 vs placebo
PlaceboOther
Placebo + SIGE
| Study group | Role | What they receive |
|---|---|---|
| low Dose 1 ZED1227 + SIGE | Experimental | Not described Receives: Drug: ZED1227 + SIGE |
| Placebo + SIGE | Placebo comparator | Not described Receives: Other: Placebo |
| medium Dose ZED1227 + SIGE | Experimental | Not described Receives: Drug: ZED1227 + SIGE |
| high dose ZED1227 + SIGE | Experimental | Not described Receives: Drug: ZED1227 + SIGE |
| low Dose 2 ZED1227 + SIGE | Experimental | Not described Receives: Drug: ZED1227 + SIGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CDSD GI Specific Symptom Score
Measured: 12 weeks
Secondary outcomes (6)
Change in PRO: Change from baseline in the percentage of Symptom Free Days (SFD)
Measured: V5 (Wk 15) over a 14-day period
Histological assessment of villous height to crypt depth ratio (VH:CrD)
Measured: 15 weeks
Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea)
Measured: 12 weeks
Proportion of subjects with histologic non-worsening, defined as change in VH:CrD ≥ 0
Measured: 15 weeks
Change in duodenal mucosal inflammation measured as the density of CD3positive intraepithelial lymphocytes (IELs)
Measured: 15 weeks
Change in serological markers TG2-IgA, TG2-IgG, DGP-IgA, DGP-IgG, and EmA-IgA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start10 Jun 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298343
- Sponsor's protocol ID
- CEC-013/CEL
- Other IDs
- 2023-506150-21, 2023
- Acronym
- CEC-013/CEL
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07298343
- Acronym / sponsor ID
- CEC-013/CEL / CEC-013/CEL
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, non-responsive Celiac Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZED1227 + SIGEoral treatment with different daily doses of ZED1227 vs placebo | Drug | high dose ZED1227 + SIGE, low Dose 1 ZED1227 + SIGE, low Dose 2 ZED1227 + SIGE, medium Dose ZED1227 + SIGE |
| PlaceboPlacebo + SIGE | Other | Placebo + SIGE |
Primary outcome
Change in CDSD GI Specific Symptom Score
Time frame: 12 weeks
6 secondary outcomes
Change in PRO: Change from baseline in the percentage of Symptom Free Days (SFD)
Time frame: V5 (Wk 15) over a 14-day period
Histological assessment of villous height to crypt depth ratio (VH:CrD)
Time frame: 15 weeks
Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea)
Time frame: 12 weeks
Proportion of subjects with histologic non-worsening, defined as change in VH:CrD ≥ 0
Time frame: 15 weeks
Change in duodenal mucosal inflammation measured as the density of CD3positive intraepithelial lymphocytes (IELs)
Time frame: 15 weeks
Change in serological markers TG2-IgA, TG2-IgG, DGP-IgA, DGP-IgG, and EmA-IgA
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Medical Center Mainz
Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZED1227 + SIGE in people with Celiac Disease, run by Dr. Falk Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CDSD GI Specific Symptom Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.