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
• 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
• 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

Related Conditions & MeSH terms

• Celiac Disease

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