Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease
This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis (biopsy) will be recruited to participate in the study. Informed consent must be obtained prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the screening period. Patients that fail to meet screening period eligibility will be discontinued from study participation at Visit 2. At Visit 2, eligibility will be confirmed, adverse events will be documented at Visit 2. Patients who continue to meet eligibility requirements at Visit 3 will begin the next treatment phase. During the treatment phase patients will self-administer treatment and gluten daily with their evening meal. At the end of the treatment period, Visit 4, patient eligibility will be confirmed and adverse events will be documented. The final visit, Visit 5, will be a safety follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
79
Latiglutenase administered orally (daily)
Placebo administered orally (daily)
Mayo Clinic - 200 First Street SW
Rochester, Minnesota, United States
Histologic Protection
The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO\>Latiglutenase
Time frame: 6 weeks
Symptom Severity
Mean percent worsening in severity for patient selected GI symptoms
Time frame: 6 weeks
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