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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Ileocolitis
• Intervention / Treatment: Drug: P28GST

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Centre hospitalier
  • Boulogne-sur-Mer, France
    • Centre Hospitalier de Boulogne
  • Dunkirk, France
    • Centre Hospitalier Dunkerque
  • Lille, France, 59037
    • CHRU, Hôpital Claude Huriez
  • Valenciennes, France
    • Centre Hospitalier,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P28GST treatment; P28GST as a parasite enzyme	Drug: P28GST; 3 injections of 100 µg of P28GST within 3 months (one injection per month); Other Names: immunotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; National Research Agency, France
• Investigators: Study Chair: Dominique DEPLANQUE, MD, PhD, Lille University Hospital

Publications and helpful links

General Publications

• Foligne B, Ple C, Titecat M, Dendooven A, Pagny A, Daniel C, Singer E, Pottier M, Bertin B, Neut C, Deplanque D, Dubuquoy L, Desreumaux P, Capron M, Standaert A. Contribution of the Gut Microbiota in P28GST-Mediated Anti-Inflammatory Effects: Experimental and Clinical Insights. Cells. 2019 Jun 12;8(6):577. doi: 10.3390/cells8060577.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimated): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Immunotherapy; Crohn disease; Helminth antigen
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Therapeutics; Biological Therapy; Immunomodulation; Immunotherapy
• Other Study ID Numbers: 2013_02; 2013-000595-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED