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

Celiac Disease Clinical Trial

Official title:

Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04243551
• Other study ID #: IMGX003-NIAID-1821
• Secondary ID: U44AI134590
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Immunogenics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• Latiglutenase
Administered orally (daily)

Other:
• Placebo
Administered orally (daily)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Immunogenics, LLC	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Severity Reduction	The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months