Latiglutenase as a Treatment for Celiac Disease

Immunogenics

Status and phase

Completed

Phase 2

Conditions

Celiac Disease

Treatments

Other: Placebo

Drug: Latiglutenase

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT03585478

1R33AT009637-01 (U.S. NIH Grant/Contract)

IMGX003-NCCIH-1721

Details and patient eligibility

About

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

Full description

This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis (biopsy) will be recruited to participate in the study. Informed consent must be obtained prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the screening period. Patients that fail to meet screening period eligibility will be discontinued from study participation at Visit 2. At Visit 2, eligibility will be confirmed, adverse events will be documented at Visit 2. Patients who continue to meet eligibility requirements at Visit 3 will begin the next treatment phase. During the treatment phase patients will self-administer treatment and gluten daily with their evening meal. At the end of the treatment period, Visit 4, patient eligibility will be confirmed and adverse events will be documented. The final visit, Visit 5, will be a safety follow-up visit.

Enrollment

79 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.