Study Stopped
Due to low enrollment related to Covid.
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
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
2 other identifiers
interventional
83
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedAugust 5, 2024
July 1, 2023
4 years
January 23, 2020
August 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom Severity Reduction
The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo.
6 months
Secondary Outcomes (4)
Health Related Quality of Life
6 months
Health Related Quality of Life
6 months
Health Related Quality of Life
6 months
Health Related Quality of Life
6 months
Study Arms (2)
Latiglutenase
ACTIVE COMPARATORIMGX003
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Murray, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- 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
Study Record Dates
First Submitted
January 23, 2020
First Posted
January 28, 2020
Study Start
November 1, 2019
Primary Completion
October 16, 2023
Study Completion
October 31, 2023
Last Updated
August 5, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share