Latiglutenase as a Treatment for Celiac Disease

• ClinicalTrials.gov Identifier: NCT03585478
• Recruitment Status: Completed
• First Posted: July 13, 2018
• Last Update Posted: December 15, 2021
• Sponsor: Immunogenics, LLC
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Immunogenics, LLC

Tracking Information

• First Submitted Date: June 29, 2018
• First Posted Date: July 13, 2018
• Last Update Posted Date: December 15, 2021
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: January 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 11, 2018)

Histologic Protection [ Time Frame: 6 weeks ]

The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO>Latiglutenase

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 11, 2018)

Symptom Severity [ Time Frame: 6 weeks ]

Mean percent worsening in severity for patient selected GI symptoms

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Latiglutenase as a Treatment for Celiac Disease
• Official Title: A Double-Blind, Placebo Controlled, Gluten Challenge Trial of the Efficacy, Safety and Tolerability of 6-weeks Treatment of Latiglutenase (IMGX003) Administration in Patients With Well-Controlled Celiac Disease
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Celiac Disease

Intervention

• Drug: Latiglutenase
  Latiglutenase administered orally (daily)
  Other Name: IMGX003
• Other: Placebo
  Placebo administered orally (daily)

Study Arms

• Active Comparator: Latiglutenase
  IMGX003
  Intervention: Drug: Latiglutenase
• Placebo Comparator: Placebo
  Placebo
  Intervention: Other: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2021): 79
• Original Estimated Enrollment (submitted: July 11, 2018): 80
• Actual Study Completion Date: January 22, 2021
• Actual Primary Completion Date: January 22, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03585478
• Other Study ID Numbers: IMGX003-NCCIH-1721; 1R33AT009637-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Immunogenics, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Immunogenics, LLC
• Original Study Sponsor: Same as current

Collaborators

• National Institutes of Health (NIH)
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Joseph Murray, MD; Mayo Clinic

• PRS Account: Immunogenics, LLC
• Verification Date: September 2021