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A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease (AGY-010)

Primary Purpose

Celiac Disease

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

AGY

placebo

About this trial

This is an interventional treatment trial for Celiac Disease

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

history of CD
experience periodic celiac related symptoms
following a gluten free diet for at least 12 months

Exclusion Criteria:

severe complications of CD or chronic active GI disease
type 1 diabetic
pregnant or breast feeding
daily ASA/NSAID use
any condition that in the opinion of the investigator, would preclude safe participation

Sites / Locations

University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AGY

placebo

Arm Description

capsule containing egg yolk with AGY

capsule containing plain egg yolk

Outcomes

Primary Outcome Measures

symptoms

celiac related symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT03707730

First Posted

October 12, 2018

Last Updated

October 29, 2019

Sponsor

Igy Inc.

Collaborators

Vetanda

1. Study Identification

Unique Protocol Identification Number

NCT03707730

Brief Title

A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease

Acronym

AGY-010

Official Title

A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Persons With Celiac Disease Age > 10 Years

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 29, 2019 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Igy Inc.

Collaborators

Vetanda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the efficacy and safety of AGY vs placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet

Detailed Description

We propose to conduct a randomized double-blind, placebo-controlled crossover trial in 149 individuals with celiac disease proven by biopsy (or other medically documented confirmation of CD, e.g. TTG counts > 10 times the upper limit of normal on two occasions) at least 12 months before study entry, and who are following a gluten-free diet but continue to have recurrent symptoms. AGY is designed to neutralize the hidden gliadin in food, thus preventing gliadin absorption and gliadin induced pathogenesis. The study will test whether AGY is safe and effective in the study population, versus placebo. Primary Objective: The primary objective will be to evaluate the effect of AGY on celiac symptoms using the daily Celiac Symptom Index (CSI). Secondary objectives: Secondary objectives will be to evaluate product safety and the effect of AGY on quality of life, autoantibodies, and gut permeability.

6. Conditions and Keywords

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

Celiac Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

randomized double-blind, placebo-controlled crossover trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

placebo controlled

Allocation

Randomized

Enrollment

149 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AGY

Arm Type

Experimental

Arm Description

capsule containing egg yolk with AGY

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

capsule containing plain egg yolk

Intervention Type

Dietary Supplement

Intervention Name(s)

AGY

Intervention Description

oral AGY taken prior to meals

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

oral placebo taken prior to meals

Primary Outcome Measure Information:

Title

symptoms

Description

celiac related symptoms

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: history of CD experience periodic celiac related symptoms following a gluten free diet for at least 12 months Exclusion Criteria: severe complications of CD or chronic active GI disease type 1 diabetic pregnant or breast feeding daily ASA/NSAID use any condition that in the opinion of the investigator, would preclude safe participation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dory Sample, MSN, MPH

Phone

780-248-5599

dory.sample@ahs.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justine Turner, MD, PhD

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1C9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dory Sample, MSN, MPH

Phone

780-248-5599

dory.sample@ahs.ca

First Name & Middle Initial & Last Name & Degree

Justine Turner, MD, PhD

First Name & Middle Initial & Last Name & Degree

Leo Dieleman, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease

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