Latiglutenase as a Treatment for Celiac Disease

Study Overview
=================
Brief Summary
-----------------
Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease

Detailed Description
-----------------
This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis (biopsy) will be recruited to participate in the study. Informed consent must be obtained prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the screening period. Patients that fail to meet screening period eligibility will be discontinued from study participation at Visit 2. At Visit 2, eligibility will be confirmed, adverse events will be documented at Visit 2. Patients who continue to meet eligibility requirements at Visit 3 will begin the next treatment phase. During the treatment phase patients will self-administer treatment and gluten daily with their evening meal. At the end of the treatment period, Visit 4, patient eligibility will be confirmed and adverse events will be documented. The final visit, Visit 5, will be a safety follow-up visit.

Official Title
-----------------
A Double-Blind, Placebo Controlled, Gluten Challenge Trial of the Efficacy, Safety and Tolerability of 6-weeks Treatment of Latiglutenase (IMGX003) Administration in Patients With Well-Controlled Celiac Disease

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Drug: Latiglutenase
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy confirmed CD diagnosis Self-reported adherence to a gluten-free diet for ≥ 12 months Agree to maintain dosing of approved prescribed and OTC medications Willing to take study treatment with evening meal during any single day Willing to take gluten foodstuff with evening meal during any single day Willing to maintain GFD for entire study duration Willing to agree to minimal ingestion outside of three main daily meals Willing and able to comply with all study procedures Access to the internet via smartphone, tablet, computer or equivalent to facilitate daily symptom reporting Must sign informed consent Exclusion Criteria: Active dermatitis herpetiformis at the time of screening IBS (Irritable Bowel Syndrome) History of any form of colitis Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with the study start) within 6 months prior to study start Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations) 6 months prior to entry Use of any immunosuppressive medications (i.e., for chronic treatment of autoimmune disease or transplant-rejection prophylaxis) 6 months prior to entry History of alcohol abuse, illegal drug use Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal) Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient Inability to give informed consent Any medical condition, other than celiac disease, which, in the opinion of the investigator, could adversely affect the patient's participation in the trial.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic Protection | The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO>Latiglutenase | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Severity | Mean percent worsening in severity for patient selected GI symptoms | 6 weeks | 

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