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

Entero Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Celiac Disease

Treatments: Other: Placebo; Drug: Latiglutenase

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04243551

IMGX003-NIAID-1821

U44AI134590 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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83 participants in 2 patient groups, including a placebo group

Latiglutenase

Active Comparator group

Description:

IMGX003

Treatment:

Drug: Latiglutenase

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo