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

Primary Purpose

Crohn's Ileocolitis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
P28GST
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Ileocolitis focused on measuring Crohn disease, Immunotherapy, Helminth antigen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre hospitalier
  • Centre Hospitalier de Boulogne
  • Centre Hospitalier Dunkerque
  • CHRU, Hôpital Claude Huriez
  • Centre Hospitalier,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

P28GST treatment

Arm Description

P28GST as a parasite enzyme

Outcomes

Primary Outcome Measures

Number of participants wtih adverse events as a measure of safety and tolerability
Clinical and blood markers change from baseline

Secondary Outcome Measures

Main immunologic and inflammatory blood and tissue markers.
Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.
Intestinal microbiota
Evolution of bacterial species by genomic analysis

Full Information

First Posted
October 28, 2014
Last Updated
June 7, 2018
Sponsor
University Hospital, Lille
Collaborators
National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02281916
Brief Title
Safety Study of P28GST Treatment in Crohn's Disease Patients
Acronym
ACROHNEM
Official Title
Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Ileocolitis
Keywords
Crohn disease, Immunotherapy, Helminth antigen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P28GST treatment
Arm Type
Experimental
Arm Description
P28GST as a parasite enzyme
Intervention Type
Drug
Intervention Name(s)
P28GST
Other Intervention Name(s)
immunotherapy
Intervention Description
3 injections of 100 µg of P28GST within 3 months (one injection per month)
Primary Outcome Measure Information:
Title
Number of participants wtih adverse events as a measure of safety and tolerability
Description
Clinical and blood markers change from baseline
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Main immunologic and inflammatory blood and tissue markers.
Time Frame
up to one year
Title
Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.
Time Frame
up to one year
Title
Intestinal microbiota
Description
Evolution of bacterial species by genomic analysis
Time Frame
at inclusion, at 4 month , at 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique DEPLANQUE, MD, PhD
Organizational Affiliation
Lille University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Centre hospitalier
City
Amiens
Country
France
Facility Name
Centre Hospitalier de Boulogne
City
Boulogne sur mer
Country
France
Facility Name
Centre Hospitalier Dunkerque
City
Dunkerque
Country
France
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier,
City
Valenciennes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31212833
Citation
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.
Results Reference
derived

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Safety Study of P28GST Treatment in Crohn's Disease Patients

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