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Study of Latiglutenase in T1D/CD Patients

Primary Purpose

Celiac Disease

Status
Terminated
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 (select):

  • Confirmed CD diagnosis
  • Confirmed T1D diagnosis
  • Seropositive
  • Gluten free diet (12 months minimum)
  • Experienced at least one self-reported moderate or greater severity symptom during the last 28 day period
  • Willing to take study treatment daily
  • Must sign informed consent

Exclusion Criteria (select):

  • Wheat allergy
  • History of peptic ulcer disease, esophagitis, IBS, IBD
  • Active colitis
  • Subjects with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
  • Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
  • Known refractory celiac disease (RCD1 or RCD2)
  • Inability to give informed consent

Sites / Locations

  • Stanford University

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

Symptom Severity Reduction
The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2021
Last Updated
July 18, 2023
Sponsor
Immunogenics, LLC
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04839575
Brief Title
Study of Latiglutenase in T1D/CD Patients
Official Title
Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Covid-19 interruptions and enrollment challenges
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunogenics, LLC
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.
Detailed Description
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.

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
Crossover Assignment
Model Description
A two-period crossover design will be used where the treatment sequences will be assigned at random.
Masking
ParticipantInvestigator
Masking Description
The PI, CRA and study biostatistician will be masked until database lock.
Allocation
Non-Randomized
Enrollment
13 (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
Administered orally (daily)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally (daily)
Primary Outcome Measure Information:
Title
Symptom Severity Reduction
Description
The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.
Time Frame
6 months

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 (select): Confirmed CD diagnosis Confirmed T1D diagnosis Seropositive Gluten free diet (12 months minimum) Experienced at least one self-reported moderate or greater severity symptom during the last 28 day period Willing to take study treatment daily Must sign informed consent Exclusion Criteria (select): Wheat allergy History of peptic ulcer disease, esophagitis, IBS, IBD Active colitis Subjects with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery) Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening Known refractory celiac disease (RCD1 or RCD2) Inability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Maahs, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Latiglutenase in T1D/CD Patients

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