Study of Latiglutenase in T1D/CD Patients

Phase 2TerminatedNCT04839575

Entero Therapeutics13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Celiac Disease

Interventions

LatiglutenaseDRUG

Administered orally (daily)

PlaceboDRUG

Administered orally (daily)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Symptom Severity Reduction

The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.

Time frame: 6 months

Data from ClinicalTrials.gov

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