Study of Latiglutenase in T1D/CD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: Latiglutenase
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A two-period crossover design will be used where the treatment sequences will be assigned at random.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Latiglutenase<br>IMGX003 | Drug: Latiglutenase<br>* Administered orally (daily)<br>* Other names: IMGX003;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Administered orally (daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Severity Reduction | The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac