Latiglutenase as a Treatment for Celiac Disease

NCT ID: NCT03585478

Last Updated: 2021-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-01-22

Brief Summary

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

Detailed 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.

Conditions

Celiac Disease

Keywords

Celiac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Latiglutenase

IMGX003

Group Type: ACTIVE_COMPARATOR

Latiglutenase

Intervention Type: DRUG

Latiglutenase administered orally (daily)

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo administered orally (daily)

Interventions

Latiglutenase

Latiglutenase administered orally (daily)

Intervention Type: DRUG

Placebo

Placebo administered orally (daily)

Intervention Type: OTHER

Other Intervention Names

IMGX003

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Immunogenics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Murray, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic - 200 First Street SW

Rochester, Minnesota, United States

Countries

United States

References

Murray JA, Syage JA, Wu TT, Dickason MA, Ramos AG, Van Dyke C, Horwath I, Lavin PT, Maki M, Hujoel I, Papadakis KA, Bledsoe AC, Khosla C, Sealey-Voyksner JA; CeliacShield Study Group. Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge. Gastroenterology. 2022 Dec;163(6):1510-1521.e6. doi: 10.1053/j.gastro.2022.07.071. Epub 2022 Aug 2.

Reference Type: DERIVED

PMID: 35931103 (View on PubMed)

Other Identifiers

1R33AT009637-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMGX003-NCCIH-1721

Identifier Type: -

Identifier Source: org_study_id