Study of Latiglutenase in T1D/CD Patients

Phase 2

Terminated

• Conditions: Celiac Disease
• Interventions: Drug: Latiglutenase; Drug: Placebo

• Registration Number: NCT04839575
• Lead Sponsor: Entero Therapeutics

Brief 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.

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2023-07
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Latiglutenase	Latiglutenase	IMGX003
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Symptom Severity Reduction	6 months	The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States