NCT02281916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 20, 2026

Status Verified

June 1, 2018

Enrollment Period

3.9 years

First QC Date

October 28, 2014

Last Update Submit

February 18, 2026

Conditions

Crohn's Ileocolitis

Keywords

Crohn diseaseImmunotherapyHelminth antigen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    at inclusion, at 4 month , at 12 month

Study Arms (1)

P28GST treatment

EXPERIMENTAL

P28GST as a parasite enzyme

Drug: P28GST

Interventions

P28GSTDRUG

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

Also known as: immunotherapy
P28GST treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • No tobacco consumption (end date of tobacco consumption 8 days before surgery).
  • Signed consent form
  • French social security coverage.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre hospitalier

Amiens, France

Location

Centre Hospitalier de Boulogne

Boulogne-sur-Mer, France

Location

Centre Hospitalier Dunkerque

Dunkirk, France

Location

CHRU, Hôpital Claude Huriez

Lille, 59037, France

Location

Centre Hospitalier,

Valenciennes, France

Location

Related Publications (1)

  • 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.

    PMID: 31212833RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Dominique DEPLANQUE, MD, PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

November 4, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 20, 2026

Record last verified: 2018-06

Locations

FR(5)