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

Study Overview
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Brief Summary
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the main objectives are to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and 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.

Official Title
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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

Conditions
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Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS)

Intervention / Treatment
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* Biological: blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpA HLA-B27 +,<br> | Biological: blood samples<br>* 7 tubes of 6 ml (42 ml of blood )<br>|
| Experimental: SpA HLA-B27-<br> | Biological: blood samples<br>* 7 tubes of 6 ml (42 ml of blood )<br>|
| Active Comparator: healthy subject<br> | Biological: blood samples<br>* 7 tubes of 6 ml (42 ml of blood )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers |  | 12 MONTHS | 
| Dosage of cytokines |  | 12 MONTHS |