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Tests treatment safety and results for Celiac Disease
Official title Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease
ClinicalTrials.gov ID: NCT07298343
What this study is testing
What is ZED1227 + SIGE?
ZED1227 + SIGE is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for celiac disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- 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 likely can't join if
- 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...
- 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...
- History or presence of dermatitis herpetiformis
The study team makes the final eligibility decision.
Where it's taking place
- Mainz, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mainz, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.