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Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

Primary Purpose

Celiac Disease

Status
Active
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
  • 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:

  • Wheat allergy
  • History of peptic ulcer disease, esophagitis, IBS, IBD
  • Active colitis, dermatitis herpetiformis
  • Diagnosed with Type 1 Diabetes
  • Patients 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

  • Mayo Clinic

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 mean percent reduction in symptom severity relative to placebo.

Secondary Outcome Measures

Health Related Quality of Life
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-I health survey relative to placebo.
Health Related Quality of Life
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-S health survey relative to placebo.
Health Related Quality of Life
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by ICDSQ health survey relative to placebo.
Health Related Quality of Life
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by SF-12 health survey relative to placebo.

Full Information

First Posted
January 23, 2020
Last Updated
July 18, 2023
Sponsor
Immunogenics, LLC
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04243551
Brief Title
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
Official Title
Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunogenics, LLC
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

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 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.
Detailed Description
This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.

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 two possible treatment sequences will be assigned at random.
Masking
ParticipantInvestigator
Masking Description
The PI, CRA and study biostatistician will be masked until database lock.
Allocation
Randomized
Enrollment
120 (Anticipated)

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
Other
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 mean percent reduction in symptom severity relative to placebo.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-I health survey relative to placebo.
Time Frame
6 months
Title
Health Related Quality of Life
Description
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-S health survey relative to placebo.
Time Frame
6 months
Title
Health Related Quality of Life
Description
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by ICDSQ health survey relative to placebo.
Time Frame
6 months
Title
Health Related Quality of Life
Description
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by SF-12 health survey 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: Biopsy confirmed CD 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: Wheat allergy History of peptic ulcer disease, esophagitis, IBS, IBD Active colitis, dermatitis herpetiformis Diagnosed with Type 1 Diabetes Patients 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
Joseph Murray, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

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