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Study of Latiglutenase in T1D/CD Patients

Sponsor
Immunogenics, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04839575
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
40
Enrollment
1
Location
2
Arms
37.8
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A two-period crossover design will be used where the treatment sequences will be assigned at random.A two-period crossover design will be used where the treatment sequences will be assigned at random.
Masking:
Double (Participant, Investigator)
Masking Description:
The PI, CRA and study biostatistician will be masked until database lock.
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 6, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Latiglutenase

IMGX003

Drug: Latiglutenase
Administered orally (daily)
Other Names:
  • IMGX003

    		•
    Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    Administered orally (daily)

    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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stanford University Palo Alto California United States 94306

    Sponsors and Collaborators

    • Immunogenics, LLC
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: David Maahs, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Immunogenics, LLC
    ClinicalTrials.gov Identifier:
    NCT04839575
    Other Study ID Numbers:
    • IMGX003-NIDDK-1921
    • 1R44DK121606-01
    First Posted:
    Apr 9, 2021
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Immunogenics, LLC
    Celiac
    Additional relevant MeSH terms:
    Celiac Disease

    Study Results

    No Results Posted as of Aug 4, 2022