Safety Study of P28GST Treatment in Crohn's Disease Patients

NCT ID: NCT02281916

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-02-28

Brief Summary

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

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).

Conditions

Crohn's Ileocolitis

Keywords

Crohn disease; Immunotherapy; Helminth antigen

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

P28GST treatment

P28GST as a parasite enzyme

Group Type: EXPERIMENTAL

P28GST

Intervention Type: DRUG

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

Interventions

P28GST

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

Intervention Type: DRUG

Other Intervention Names

immunotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Agency, France

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique DEPLANQUE, MD, PhD

Role: STUDY_CHAIR

Lille University Hospital

Locations

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,

Valenciennes, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 31212833 (View on PubMed)

Other Identifiers

2013_02

Identifier Type: -

Identifier Source: org_study_id

2013-000595-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id