Study of Latiglutenase in T1D/CD Patients

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunogenics, LLC
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

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-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