Safety Study of P28GST Treatment in Crohn's Disease Patients

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; National Research Agency, France

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.