Safety Study of P28GST Treatment in Crohn's Disease Patients

Crohn's Ileocolitis Clinical Trial

— ACROHNEM  

Official title:

Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281916
• Other study ID #: 2013_02
• Secondary ID: 2013-000595-15
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: February 2018

Study information

• Verified date: June 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Ileocolitis

Intervention

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

Locations

Country	Name	City	State
France	Centre hospitalier	Amiens
France	Centre Hospitalier de Boulogne	Boulogne sur mer
France	Centre Hospitalier Dunkerque	Dunkerque
France	CHRU, Hôpital Claude Huriez	Lille
France	Centre Hospitalier,	Valenciennes

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Main immunologic and inflammatory blood and tissue markers.		up to one year
Secondary	Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.		up to one year
Secondary	Intestinal microbiota	Evolution of bacterial species by genomic analysis	at inclusion, at 4 month , at 12 month