NCT07298343 Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease
| NCT ID | NCT07298343 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dr. Falk Pharma GmbH |
| Condition | Celiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 356 participants in total. It began in 2024-06-10 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07298343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07298343 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07298343 currently recruiting?
Yes, NCT07298343 is actively recruiting participants. Visit ClinicalTrials.gov or contact Dr. Falk Pharma GmbH to inquire about joining.
Where is the NCT07298343 trial being conducted?
This trial is being conducted at Mainz, Germany.
Who is sponsoring the NCT07298343 clinical trial?
NCT07298343 is sponsored by Dr. Falk Pharma GmbH. The trial plans to enroll 356 participants.