Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic 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
NCT04243551
Other Study ID Numbers:
IMGX003-NIAID-1821
First Submitted
January 22, 2020
First Posted
January 27, 2020
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 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 DiseaseIntervention/Treatment
Celiac Disease
Drug: LatiglutenaseOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment83 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 DateOctober 31, 2019
Actual Primary Completion DateOctober 15, 2023
Actual Study Completion DateOctober 30, 2023

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. Symptom Severity Reduction
    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
    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
    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
    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
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 CollaboratorsEntero Therapeutics
Locations
Mayo Clinic | Rochester Minnesota, United States, 55905
Investigators
Principal Investigator: Joseph Murray, MD, Mayo Clinic