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

Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure

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.

Study Overview

• Status: Terminated
• Conditions: Celiac Disease
• Intervention / Treatment: Drug: Latiglutenase; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Administered orally (daily)
Active Comparator: Latiglutenase; IMGX003	Drug: Latiglutenase; Administered orally (daily); Other Names: IMGX003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Severity Reduction	The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life	A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-I health survey relative to placebo.	6 months
Health Related Quality of Life	A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-S health survey relative to placebo.	6 months
Health Related Quality of Life	A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by ICDSQ health survey relative to placebo.	6 months
Health Related Quality of Life	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.	6 months

Collaborators and Investigators

• Sponsor: Entero Therapeutics
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Joseph Murray, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Celiac
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: IMGX003-NIAID-1821; U44AI134590 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No