Safety Study of P28GST Treatment in Crohn's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02281916
• Date of registration: 28/10/2014
• Prospective Registration: No
• Primary sponsor: University Hospital, Lille
• Public title: Safety Study of P28GST Treatment in Crohn's Disease Patients ACROHNEM
• Scientific title: Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
• Date of first enrolment: March 2014
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02281916
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Dominique DEPLANQUE, MD, PhD
• Affiliation: Lille University Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Ileocolitis

Intervention(s)

Drug: P28GST

Primary Outcome(s)

Number of participants wtih adverse events as a measure of safety and tolerability [Time Frame: up to one year]

Secondary Outcome(s)

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]

Intestinal microbiota [Time Frame: at inclusion, at 4 month , at 12 month]

Main immunologic and inflammatory blood and tissue markers. [Time Frame: up to one year]

Secondary ID(s)

2013-000595-15

2013_02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut National de la Santé Et de la Recherche Médicale, France

National Research Agency, France