Study of Latiglutenase in T1D/CD Patients

NCT04839575 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: IMGX003-NIDDK-19211R44DK121606-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Celiac Disease

Keywords

Celiac

Outcome Measures

Primary Outcomes (1)

• Symptom Severity Reduction

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

  6 months

Study Arms (2)

Latiglutenase

ACTIVE COMPARATOR

IMGX003

Drug: Latiglutenase

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Latiglutenase DRUG

Administered orally (daily)

Also known as: IMGX003

Latiglutenase

Placebo DRUG

Administered orally (daily)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Entero Therapeutics: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Immunogenics, LLC: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

ALV003

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Maahs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The PI, CRA and study biostatistician will be masked until database lock.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A two-period crossover design will be used where the treatment sequences will be assigned at random.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: April 6, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: August 5, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)