Latiglutenase as a Treatment for Celiac Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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

Key facts

Study ID

NCT03585478

Run by

Immunogenics, LLC

People needed

79

Starts

2019-03-01

Expected to finish

2021-01-22

Last updated by the study team

2021-12-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic - 200 First Street SW — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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