Study of Latiglutenase in T1D/CD Patients

Recruitment Status
TERMINATED
(See Contacts and Locations)Verified June 2023 by Entero Therapeutics
Sponsor
Entero Therapeutics
Information Provided by (Responsible Party)
Entero Therapeutics
Clinicaltrials.gov Identifier
NCT04839575
Other Study ID Numbers:
IMGX003-NIDDK-1921
First Submitted
April 6, 2021
First Posted
April 8, 2021
Last Update Posted
August 4, 2024
Last Verified
June 2023

ClinicalTrials.gov processed this data on July 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Celiac Disease
Drug: LatiglutenaseDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment13 participants
Design AllocationNon-Randomized
Interventional ModelCrossover Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleProspective, 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
Study Start DateApril 5, 2021
Actual Primary Completion DateDecember 18, 2022
Actual Study Completion DateDecember 18, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
Latiglutenase
IMGX003
Drug: Latiglutenase
Administered orally (daily)
Placebo
Placebo
Drug: Placebo
Administered orally (daily)

Outcome Measures

Primary Outcome Measures
  1. Symptom Severity Reduction
    The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria (select):
Confirmed CD diagnosis
Confirmed T1D 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
Inclusion Criteria (select):
Confirmed CD diagnosis
Confirmed T1D 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 (select):
Wheat allergy
History of peptic ulcer disease, esophagitis, IBS, IBD
Active colitis
Subjects 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

Contacts and Locations

Sponsors and CollaboratorsEntero Therapeutics
Locations
Stanford University | Palo Alto California, United States, 94306
Investigators
Principal Investigator: David Maahs, MD, Stanford University