Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

Phase 2

Terminated

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

• Registration Number: NCT04243551
• Lead Sponsor: Entero Therapeutics

Brief Summary

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.

Detailed Description

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-28
• Status Verified: 2023-07
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-31
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Biopsy confirmed CD diagnosis
• Seropositive
• Gluten free diet (12 months minimum)
• Experienced at least one self reported moderate or greater severity symptom during the last 28 day period
• Willing to take study treatment daily
• Must sign informed consent

Exclusion Criteria

• Wheat allergy
• History of peptic ulcer disease, esophagitis, IBS, IBD
• Active colitis, dermatitis herpetiformis
• Diagnosed with Type 1 Diabetes
• Patients with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
• Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
• Known refractory celiac disease (RCD1 or RCD2)
• Inability to give informed consent

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 mean percent reduction in symptom severity relative to placebo.

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life	6 months	A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by SF-12 health survey relative to placebo.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States