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 August 1, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
TERMINATED (See Contacts and Locations)Verified July 2023 by Entero Therapeutics, National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor
Entero TherapeuticsInformation Provided by (Responsible Party)
Entero TherapeuticsClinicaltrials.gov Identifier
NCT04243551Other Study ID Numbers: IMGX003-NIAID-1821
First Submitted: January 23, 2020
First Posted: January 28, 2020
Last Update Posted: August 5, 2024
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 |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 83 participants |
Design Allocation | Randomized |
Interventional Model | Crossover Assignment |
Masking | Double |
Primary Purpose | Treatment |
Official Title | 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 |
Study Start Date | November 1, 2019 |
Actual Primary Completion Date | October 16, 2023 |
Actual Study Completion Date | October 31, 2023 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Entero Therapeutics, National Institute of Allergy and Infectious Diseases (NIAID) |
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National Institute of Allergy and Infectious Diseases (NIAID) | |
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Investigators |
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More Information
Additional Relevant MeSH Terms
- Celiac Disease
- Malabsorption Syndromes
- Intestinal Diseases
- Gastrointestinal Diseases
- Digestive System Diseases
- Metabolic Diseases