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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: Latiglutenase
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

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: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A two-period crossover design will be used where the two possible 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 | Other: 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 mean percent reduction in symptom severity relative to placebo. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

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