Study of Latiglutenase in T1D/CD Patients

NCT04839575 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-08-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Latiglutenase

Administered orally (daily)

DRUG

Placebo

Administered orally (daily)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Immunogenics, LLC

    collaborator INDUSTRY
  • Entero Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Maahs, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2022-12-19
Completion
2022-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04839575 on ClinicalTrials.gov