A Phase 2 interventional study of ZED1227 + SIGE and Placebo in Celiac Disease, sponsored by Dr. Falk Pharma GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Dr. Falk Pharma GmbH · Phase 2, Interventional, and Treatment
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 356 is above the median of 50 across 214 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Dr. Falk Pharma GmbH is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ZED1227 + SIGE
Other: Placebo
Drug: ZED1227 + SIGE
Drug: ZED1227 + SIGE
Drug: ZED1227 + SIGE
Drug page: ZED1227
oral treatment with different daily doses of ZED1227 vs placebo
Placebo + SIGE
Change in CDSD GI Specific Symptom Score
Time frame: 12 weeks
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
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Aug 2027, 38 months after the start.
Of 24 phase 2 interventional studies under Celiac Disease, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's planned 38 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: ZED1227