Latiglutenase as a Treatment for Celiac Disease

A Double-Blind, Placebo Controlled, Gluten Challenge Trial of the Efficacy, Safety and Tolerability of 6-weeks Treatment of Latiglutenase (IMGX003) Administration in Patients With Well-Controlled Celiac Disease

Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease

Study Overview

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

Detailed Description

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
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - 200 First Street SW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Biopsy confirmed CD diagnosis
• Self-reported adherence to a gluten-free diet for ≥ 12 months
• Agree to maintain dosing of approved prescribed and OTC medications
• Willing to take study treatment with evening meal during any single day
• Willing to take gluten foodstuff with evening meal during any single day
• Willing to maintain GFD for entire study duration
• Willing to agree to minimal ingestion outside of three main daily meals
• Willing and able to comply with all study procedures
• Access to the internet via smartphone, tablet, computer or equivalent to facilitate daily symptom reporting
• Must sign informed consent

Exclusion Criteria:

• Active dermatitis herpetiformis at the time of screening
• IBS (Irritable Bowel Syndrome)
• History of any form of colitis
• Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with the study start) within 6 months prior to study start
• Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations) 6 months prior to entry
• Use of any immunosuppressive medications (i.e., for chronic treatment of autoimmune disease or transplant-rejection prophylaxis) 6 months prior to entry
• History of alcohol abuse, illegal drug use
• Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal)
• Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization
• Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient
• Inability to give informed consent
• Any medical condition, other than celiac disease, which, in the opinion of the investigator, could adversely affect the patient's participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic Protection	The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO>Latiglutenase	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Severity	Mean percent worsening in severity for patient selected GI symptoms	6 weeks

Collaborators and Investigators

• Sponsor: Immunogenics, LLC
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Joseph Murray, MD, Mayo Clinic

Publications and helpful links

General Publications

• Murray JA, Syage JA, Wu TT, Dickason MA, Ramos AG, Van Dyke C, Horwath I, Lavin PT, Maki M, Hujoel I, Papadakis KA, Bledsoe AC, Khosla C, Sealey-Voyksner JA; CeliacShield Study Group. Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge. Gastroenterology. 2022 Dec;163(6):1510-1521.e6. doi: 10.1053/j.gastro.2022.07.071. Epub 2022 Aug 2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: September 1, 2021

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-NCCIH-1721; 1R33AT009637-01 (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