Safety Study of P28GST Treatment in Crohn's Disease Patients (ACROHNEM)

University Hospital, Lille

Status and phase

Completed

Phase 2

Conditions

Crohn's Ileocolitis

Treatments

Drug: P28GST

Study type

Interventional

Funder types

Other

Identifiers

NCT02281916

2013-000595-15 (EudraCT Number)

2013_02

Details and patient eligibility

About

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.

Full description

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).

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.