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NCT04839575 Clinical Trial

Study of Latiglutenase in T1D/CD Patients

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04839575
Other study ID # IMGX003-NIDDK-1921
Secondary ID 1R44DK121606-01
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 6, 2021
Est. completion date December 19, 2022

Study information
Verified date July 2023
Source Immunogenics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date December 19, 2022
Est. primary completion date December 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Latiglutenase
Administered orally (daily)
• Placebo
Administered orally (daily)

Locations
Country Name City State
United States Stanford University Palo Alto California

Sponsors (2)
Lead Sponsor Collaborator
Immunogenics, LLC National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom Severity Reduction The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo. 6 months
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