Prospective, 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

ClinicalTrials.gov processed this data on July 18, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

TERMINATED (See Contacts and Locations)
Verified July 2023 by Immunogenics, LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor

Immunogenics, LLC

Information Provided by (Responsible Party)

Immunogenics, LLC

Clinicaltrials.gov Identifier

NCT04839575
Other Study ID Numbers: IMGX003-NIDDK-1921
First Submitted: April 7, 2021
First Posted: April 9, 2021
Last Update Posted: July 20, 2023
Last Verified: July 2023
History of Changes

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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 Disease Intervention/Treatment
  • Celiac Disease
  • Drug: Latiglutenase
  • Drug: 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 6, 2021
Actual Primary Completion DateDecember 19, 2022
Actual Study Completion DateDecember 19, 2022

Groups and Cohorts

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

    Outcome Measures

    Primary Outcome Measures

    1. Symptom Severity Reduction [6 months]
      The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 80 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • elect):
    • 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
    • elect):
    • 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 Collaborators Immunogenics, LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Locations
    • Stanford University | Palo Alto, California, United States, 94306
    Investigators
    • Principal Investigator: David Maahs, MD, Stanford University

    More Information

    Additional Relevant MeSH Terms

    • Celiac Disease
    • Malabsorption Syndromes
    • Intestinal Diseases
    • Gastrointestinal Diseases
    • Digestive System Diseases
    • Metabolic Diseases