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Enzyme

Latiglutenase for Celiac Disease

Phase 2
Waitlist Available
Led By Joseph Murray, MD
Research Sponsored by Immunogenics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Experienced at least one self reported moderate or greater severity symptom during the last 28 day period
Gluten free diet (12 months minimum)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a new medication for celiac disease patients who have been following a gluten-free diet for at least a year.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had at least one symptom that you would describe as moderate or worse in the past 28 days.
Select...
You have been on a gluten-free diet for at least 12 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptom Severity Reduction
Secondary outcome measures
Health Related Quality of Life

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LatiglutenaseActive Control1 Intervention
IMGX003
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,261 Previous Clinical Trials
5,482,886 Total Patients Enrolled
Immunogenics, LLCLead Sponsor
3 Previous Clinical Trials
132 Total Patients Enrolled
3 Trials studying Celiac Disease
132 Patients Enrolled for Celiac Disease
Joseph Murray, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
182 Total Patients Enrolled
2 Trials studying Celiac Disease
110 Patients Enrolled for Celiac Disease

Media Library

Latiglutenase (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT04243551 — Phase 2
Celiac Disease Research Study Groups: Placebo, Latiglutenase
Celiac Disease Clinical Trial 2023: Latiglutenase Highlights & Side Effects. Trial Name: NCT04243551 — Phase 2
Latiglutenase (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04243551 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial represent a pioneering endeavor?

"At the time of writing, 2 clinical trials are recruiting participants to study Latiglutenase in two distinct cities across one nation. This investigational drug was initiated by Immunogenics, LLC back in 2019 and initially included 120 volunteers; it has since gone on to complete its Phase 2 Drug Approval stage with a total of 18324 studies completed."

Answered by AI

Is the enrollment period for this experiment limited to individuals over 25 years of age?

"This trial is open to all adults aged 18-80. For minors, there are 12 clinical trials available and 24 for those that exceed the cutoff age of 65 years old."

Answered by AI

What is the current patient count for this inquiry?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, initially posted on November 1st 2019, is currently recruiting patients. About 120 subjects need to be enrolled from a single medical facility."

Answered by AI

Are recruitment efforts still underway for this research endeavor?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this scientific investigation, which was initially posted November 1st 2019, is currently recruiting participants. Approximately 120 patients need to be sourced from a single medical facility."

Answered by AI

Has Latiglutenase been granted regulatory acceptance by the FDA?

"Latiglutenase has been deemed a score of 2 on Power's safety scale, since clinical trials have only provided evidence supporting its security rather than efficacy."

Answered by AI

Can you shed light on prior experiments related to Latiglutenase?

"Currently, two medical trials investigating the efficacy of Latiglutenase are underway. There is no Phase 3 trial in progress at this time, however there are a couple sites conducting research with the drug located mainly in Palo Alto, California."

Answered by AI

What criteria must individuals satisfy to be considered a viable candidate for this experiment?

"Eligibility criteria for this study requires volunteers to have celiac disease and aged between 18-80 years old. The research team aims to enrol a total of 120 participants in the trial."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
~22 spots leftby Mar 2025