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Enzyme

Latiglutenase for Celiac Disease

Phase 2
Waitlist Available
Led By David Maahs, 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 whether a new treatment can help people with Type 1 diabetes and celiac disease who are trying to follow a gluten-free diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had a moderate or severe symptom that you have identified and reported in the last 28 days.
Select...
You have been following 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

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?

Immunogenics, LLCLead Sponsor
3 Previous Clinical Trials
239 Total Patients Enrolled
3 Trials studying Celiac Disease
239 Patients Enrolled for Celiac Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,173 Total Patients Enrolled
3 Trials studying Celiac Disease
441 Patients Enrolled for Celiac Disease
David Maahs, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

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

What is the current participant count of this trial?

"Indeed, the information on clinicaltrials.gov suggests that this medical trial is enrolling participants at present. It was first published in April 2021 and received a recent update in August 2022; 40 individuals are expected to partake from one clinic."

Answered by AI

Who meets the criteria to join this research project?

"In this clinical trial, 40 individuals suffering from celiac disease and type 1 diabetes between 18-80 years old are being recruited. The primary prerequisites for applicants are: a confirmed CD diagnosis; presence of antibodies confirming T1D status; ongoing consumption of gluten free diet (for 12 months or more); occurrence of at least one moderate symptom in the last 28 days; consent to take study treatment every day, and agreement to sign informed consent form."

Answered by AI

What harmful effects could arise from taking Latiglutenase IMGX003?

"It is estimated that Latiglutenase IMGX003 has a score of 2 for safety on a scale from 1 to 3 because this trial is currently in Phase 2, indicating there are some supporting data regarding its security but no evidence yet backing up its efficacy."

Answered by AI

Does this research effort introduce a new concept or methodology?

"The first clinical trials surrounding Latiglutenase IMGX003 began in 2019, led by Immunogenics, LLC. After its initial Phase 1 study with 120 participants, the drug gained approval to proceed into Phase 2 testing. At present, there are two active studies of this medication occurring across one nation's two major cities."

Answered by AI

Are there still opportunities for participants to join this clinical experiment?

"Per the information on clinicaltrials.gov, this investigation is currently accepting volunteers and was first posted April 6th 2021 with a recent edit occurring August 2nd 2022."

Answered by AI

Does the eligibility for this research extend to seniors above 75 years of age?

"This medical study seeks out individuals over 18 yet below 80 years of age to be enrollees."

Answered by AI

Could you provide information on other experiments that have utilized Latiglutenase IMGX003?

"Presently, two clinical trials are deployed to investigate the effects of Latiglutenase IMGX003. Neither of these studies is in Phase 3 yet. The research sites for this treatment are based mainly in Palo Alto, California but there exist other locations as well conducting similar investigations."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
Florida
How old are they?
18 - 65
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking to help in anyway I can. I have had celiac disease for 4 years.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Stanford University: < 24 hours
Average response time
  • < 1 Day
~3 spots leftby Apr 2025