Latiglutenase as a Treatment for Celiac Disease

• Status: Completed
• Trial end date: 2021-01-22
• Target enrollment: 0
• Participant gender: All

Summary

Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease

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

Details

• Lead Sponsor: Immunogenics, LLC
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Biopsy confirmed CD diagnosis

• Self-reported adherence to a gluten-free diet for ≥ 12 months

• Agree to maintain dosing of approved prescribed and OTC medications

• Willing to take study treatment with evening meal during any single day

• Willing to take gluten foodstuff with evening meal during any single day

• Willing to maintain GFD for entire study duration

• Willing to agree to minimal ingestion outside of three main daily meals

• Willing and able to comply with all study procedures

• Access to the internet via smartphone, tablet, computer or equivalent to facilitate daily symptom reporting

• Must sign informed consent

Exclusion Criteria:

• Active dermatitis herpetiformis at the time of screening

• IBS (Irritable Bowel Syndrome)

• History of any form of colitis

• Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with the study start) within 6 months prior to study start

• Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations) 6 months prior to entry

• Use of any immunosuppressive medications (i.e., for chronic treatment of autoimmune disease or transplant-rejection prophylaxis) 6 months prior to entry

• History of alcohol abuse, illegal drug use

• Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal)

• Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization

• Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient

• Inability to give informed consent

• Any medical condition, other than celiac disease, which, in the opinion of the investigator, could adversely affect the patient's participation in the trial.