Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

Phase 2TerminatedNCT04243551

Entero Therapeutics83 enrolled

Overview

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Celiac Disease

Interventions

LatiglutenaseDRUG

Administered orally (daily)

PlaceboOTHER

Administered orally (daily)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy confirmed CD 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: * Wheat allergy * History of peptic ulcer disease, esophagitis, IBS, IBD * Active colitis, dermatitis herpetiformis * Diagnosed with Type 1 Diabetes * Patients 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)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Symptom Severity Reduction

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

Time frame: 6 months

Secondary Outcomes

Health Related Quality of Life

A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-I health survey relative to placebo.

Time frame: 6 months

Health Related Quality of Life

A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-S health survey relative to placebo.

Time frame: 6 months

Health Related Quality of Life

A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by ICDSQ health survey relative to placebo.

Time frame: 6 months

Health Related Quality of Life

A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by SF-12 health survey relative to placebo.

Time frame: 6 months

Data from ClinicalTrials.gov

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