Safety Study of P28GST Treatment in Crohn's Disease Patients

Study Overview
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Brief Summary
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This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.

Detailed Description
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To carry out this study, 24 moderate CD patients will be enrolled in a safety phase 2a study. CD patients will be included after intestinal resection surgery or in moderate Crohn's Disease (CD). Drug therapy will consisted in 3 injections of 100 µg of P28GST within 3 months (one injection per month). The main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. Secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index).

Official Title
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Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial

Conditions
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Crohn's Ileocolitis

Intervention / Treatment
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* Drug: P28GST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between the ages of ≥18 years at inclusion. Subjects with ileal or ileo-colic CD without fistula Subjects operated or not CDAI score < 220 no concomitant treatment excepted salicylates Women of child bearing potential must be negative for pregnancy prior to study enrolment contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection . No tobacco consumption (end date of tobacco consumption 8 days before surgery). Signed consent form French social security coverage. Exclusion Criteria: Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST Subject who use of corticosteroids for 15 days before first injection of P28GST Subject with history of vaccine hyper sensitivity or allergy. Subject with any other clinical manifestation determined by the investigator Subject wih AIDS, B or C hepatitis.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P28GST treatment<br>P28GST as a parasite enzyme | Drug: P28GST<br>* 3 injections of 100 µg of P28GST within 3 months (one injection per month)<br>* Other names: immunotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants wtih adverse events as a measure of safety and tolerability | Clinical and blood markers change from baseline | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main immunologic and inflammatory blood and tissue markers. |  | up to one year | 
| Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination. |  | up to one year | 
| Intestinal microbiota | Evolution of bacterial species by genomic analysis | at inclusion, at 4 month , at 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn disease, Immunotherapy, Helminth antigen