Safety Study of P28GST Treatment in Crohn's Disease Patients

Phase 2CompletedNCT02281916

University Hospital, Lille10 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Ileocolitis

Interventions

P28GSTDRUG

3 injections of 100 µg of P28GST within 3 months (one injection per month)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Centre hospitalier

Amiens, France

Centre Hospitalier de Boulogne

Boulogne-sur-Mer, France

Centre Hospitalier Dunkerque

Dunkirk, France

CHRU, Hôpital Claude Huriez

Lille, France

Centre Hospitalier,

Outcomes

Primary Outcomes

Number of participants wtih adverse events as a measure of safety and tolerability

Clinical and blood markers change from baseline

Time frame: up to one year

Secondary Outcomes

Main immunologic and inflammatory blood and tissue markers.

Time frame: up to one year

Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.

Time frame: up to one year

Intestinal microbiota

Evolution of bacterial species by genomic analysis

Time frame: at inclusion, at 4 month , at 12 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.