NCT04839575

Study of Latiglutenase in T1D/CD Patients

Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Entero Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.

Detailed description

This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	Latiglutenase	Administered orally (daily)
DRUG	Placebo	Administered orally (daily)

Timeline

• Start date: 2021-04-06
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2021-04-09
• Last updated: 2024-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study