Clinical trial NCT02281916: Safety Study of P28GST Treatment in Crohn's Disease Patients
Official title: Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Ileocolitis
Keywords: Crohn disease
Immunotherapy
Helminth antigen
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-11-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of participants wtih adverse events as a measure of safety and tolerability
timeFrame: up to one year
Secondary outcomes:
measure: Main immunologic and inflammatory blood and tissue markers.
timeFrame: up to one year
measure: Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.
timeFrame: up to one year
measure: Intestinal microbiota
timeFrame: at inclusion, at 4 month , at 12 month
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre hospitalier
city: Boulogne sur mer
country: France
facility: Centre Hospitalier de Boulogne
city: Dunkerque
country: France
facility: Centre Hospitalier Dunkerque
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
city: Valenciennes
country: France
facility: Centre Hospitalier,
Study officials:
affiliation: Lille University Hospital
name: Dominique DEPLANQUE, MD, PhD
role: STUDY_CHAIR
References:
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.