Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients 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 Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• Biopsy confirmed CD 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, dermatitis herpetiformis

• Diagnosed with Type 1 Diabetes

• Patients 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