Study of Latiglutenase in T1D/CD Patients

Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure

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.

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.

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