Safety Study of P28GST Treatment in Crohn's Disease Patients | NCT02281916

Studies
Safety Study of P28GST Treatment in Crohn's Disease Patients

NCT02281916

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Feb 20, 2026Actual

Enrollment

10Actual

Phase

Phase 2

Conditions

Crohn's Ileocolitis

Interventions

P28GST

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-000595-15	EudraCT Number

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2018Actual

First Submitted Date

Oct 28, 2014

First Submission Date that Met QC Criteria

Nov 3, 2014

First Posted Date

Nov 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2026

Last Update Posted Date

Feb 20, 2026Actual

Name	Class
National Research Agency, France	OTHER
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P28GST treatment	Experimental	P28GST as a parasite enzyme	Drug: P28GST

Interventions

Name	Type	Description	Arm Group Labels	Other Names
P28GST	Drug	3 injections of 100 µg of P28GST within 3 months (one injection per month)	P28GST treatment

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dominique DEPLANQUE, MD, PhD	University Hospital, Lille	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier		Amiens			France
Centre Hospitalier de Boulogne

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31212833	Result	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.

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics