Trial Search Results

Prospective Double-Blind PBO-Controlled Combined Crossover Randomized Withdrawal Study of Latiglutenase in T1D/CD Pts

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Immunogenics, LLC

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Stanford Investigator(s):

Intervention(s):

  • Drug: Latiglutenase
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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:

   - Wheat allergy

   - History of peptic ulcer disease, esophagitis, IBS, IBD

   - Active colitis

   - Subjects with known rapid gastric emptying (post-bariatrc 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

Ages Eligible for Study

14 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting