Study of Latiglutenase in T1D/CD Patients

Entero Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Celiac Disease

Treatments: Drug: Latiglutenase; Drug: Placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04839575

IMGX003-NIDDK-1921

1R44DK121606-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 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:

Drug: Placebo