Study of Latiglutenase in T1D/CD Patients

Study Purpose

This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria (select):

  • - Confirmed CD diagnosis.
  • - Confirmed T1D 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 (select):
  • - Wheat allergy.
  • - History of peptic ulcer disease, esophagitis, IBS, IBD.
  • - Active colitis.
  • - Subjects 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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Immunogenics, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Maahs, MD
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, NIH
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.

Arms & Interventions


Active Comparator: Latiglutenase


Placebo Comparator: Placebo



Drug: - Latiglutenase

Administered orally (daily)

Drug: - Placebo

Administered orally (daily)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Palo Alto, California




Stanford University

Palo Alto, California, 94306

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