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Completed

NCT Number: NCT03322618

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

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.

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Key information

Conditions

Axial Spondyloarthritis (AxSpA) Ankylosing Spondylitis (AS) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples

Biological

7 tubes of 6 ml (42 ml of blood )

Primary outcomes

  1. 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)

    Time frame: 12 MONTHS

    by flow cytometry.

Secondary outcomes

  1. Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers

    Time frame: 12 MONTHS

  2. Dosage of cytokines

    Time frame: 12 MONTHS

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Acronym: KIR3DL2

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2017
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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