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Latiglutenase as a Treatment for Celiac Disease

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latiglutenase
Placebo
Sponsored by
Immunogenics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Celiac

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mayo Clinic - 200 First Street SW

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Latiglutenase

Placebo

Arm Description

IMGX003

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Symptom Severity
Mean percent worsening in severity for patient selected GI symptoms

Full Information

First Posted
June 29, 2018
Last Updated
November 30, 2021
Sponsor
Immunogenics, LLC
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03585478
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
January 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunogenics, LLC
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latiglutenase
Arm Type
Active Comparator
Arm Description
IMGX003
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Latiglutenase
Other Intervention Name(s)
IMGX003
Intervention Description
Latiglutenase administered orally (daily)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally (daily)
Primary Outcome Measure Information:
Title
Histologic Protection
Description
The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO>Latiglutenase
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Symptom Severity
Description
Mean percent worsening in severity for patient selected GI symptoms
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Murray, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic - 200 First Street SW
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35931103
Citation
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.
Results Reference
derived

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Latiglutenase as a Treatment for Celiac Disease

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