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

August 31, 2022 updated by: Assistance Publique Hopitaux De Marseille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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)
Time Frame: 12 MONTHS
by flow cytometry.
12 MONTHS

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2017

Primary Completion (Actual)

September 17, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-33
  • 2017-A01705-48 (Other Identifier: N°IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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