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

Sponsor
Dr. Falk Pharma GmbH
Study ID
NCT07298343
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ZED1227 + SIGE — DRUG
    oral treatment with different daily doses of ZED1227 vs placebo
  • Placebo — OTHER
    Placebo + SIGE

Study Details

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

Key Dates

First listed
Dec 23, 2025
Start date
Jun 10, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: low Dose 1 ZED1227 + SIGE
  • Placebo Comparator: Placebo + SIGE
  • Experimental: medium Dose ZED1227 + SIGE
  • Experimental: high dose ZED1227 + SIGE
  • Experimental: low Dose 2 ZED1227 + SIGE

Primary Outcome Measure

Change in CDSD GI Specific Symptom Score [ Time Frame: 12 weeks ]

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