Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples

Ankylosing Spondylitis (AS) Clinical Trial

— KIR3DL2  

Official title:

Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322618
• Other study ID #: 2017-33
• Secondary ID: 2017-A01705-48
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: September 17, 2019

Study information

• Verified date: August 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the main objectives are 1. to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and 2. to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients. The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent of the patient signed before any procedure planned to the protocol
• SPA axial according to the criteria of the ASAS (international Assessment of SpondyloArthritis Society)
• Known Status HLA B27
• Disease activates with a score of BASDAI = 4/10. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Score) is a composite indication(index), validated, used in the therapeutic essays and in current practice for the evaluation of the activity of the SPA.
• Naive Patients of thorough treatment
• Patients of 18 and more years old

Exclusion Criteria:

• Minors
• Pregnant or breast-feeding Women
• Adults under guardianship
• People staying in a sanitary or social establishment
• People in emergency situation
• Not profitable People of a national insurance scheme
• Private persons of freedom
• Treatment by corticoids during the last 30 days before the inclusion
• Treatment by anti-TNF or quite different biomedicine
• Treatment by sulfasalazine
• Reached concomitant by another active chronic inflammatory disease
• Infection chronicles by VHB, VHC or HIV
• Patients included in another study of clinical trial

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Axial Spondyloarthritis (axSpA)
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• blood samples
7 tubes of 6 ml (42 ml of blood )

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the present various immunizing populations in patients' blood SPA HLA-B27 + and HLA-B27-(Lymphocytes T CD4 (Th1 Th2, Th17, Tregs), lymphocytes T CD8, cells NK, lymphocytes B, monocytes)	by flow cytometry.	12 MONTHS
Secondary	Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers		12 MONTHS
Secondary	Dosage of cytokines		12 MONTHS