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

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

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified July 2023 by Immunogenics, LLC, National Institute of Allergy and Infectious Diseases (NIAID)

Sponsor

Immunogenics, LLC

Information Provided by (Responsible Party)

Immunogenics, LLC

Clinicaltrials.gov Identifier

NCT04243551
Other Study ID Numbers: IMGX003-NIAID-1821
First Submitted: January 23, 2020
First Posted: January 28, 2020
Last Update Posted: July 20, 2023
Last Verified: July 2023
History of Changes

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Study 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.
Condition or Disease Intervention/Treatment
  • Celiac Disease
  • Drug: Latiglutenase
  • Other: Placebo

Study Design

Study TypeInterventional
Anticipated Enrollment120 participants
Design AllocationRandomized
Interventional ModelCrossover Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleMulticenter, 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
Study Start DateNovember 1, 2019
Anticipated Primary Completion DateDecember 2023
Anticipated Study Completion DateDecember 2023

Groups and Cohorts

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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Health Related Quality of Life [6 months]
      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.
    2. Health Related Quality of Life [6 months]
      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.
    3. Health Related Quality of Life [6 months]
      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.
    4. Health Related Quality of Life [6 months]
      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.

    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
    • 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

    Contacts and Locations

    Sponsors and Collaborators Immunogenics, LLC, National Institute of Allergy and Infectious Diseases (NIAID)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Locations
    • Mayo Clinic | Rochester, Minnesota, United States, 55905
    Investigators
    • Principal Investigator: Joseph Murray, MD, Mayo Clinic

    More Information

    Additional Relevant MeSH Terms

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