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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03322618
Acronym
KIR3DL2
Enrollment
24
Registered
2017-10-26
Start date
2017-12-18
Completion date
2019-09-17
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis (AS), Axial Spondyloarthritis (axSpA)

Brief 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.

Interventions

BIOLOGICALblood samples

7 tubes of 6 ml (42 ml of blood )

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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)12 MONTHSby flow cytometry.

Secondary

MeasureTime frame
Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers12 MONTHS
Dosage of cytokines12 MONTHS

Countries

France

Contacts

STUDY_DIRECTORjean olivier ARNAUD

Assistance Publique Hopitaux De Marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026