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

Primary Purpose

Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Axial Spondyloarthritis (axSpA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

SpA HLA-B27 +,

SpA HLA-B27-

healthy subject

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2017
Last Updated
August 31, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03322618
Brief Title
Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SpA HLA-B27 +,
Arm Type
Experimental
Arm Title
SpA HLA-B27-
Arm Type
Experimental
Arm Title
healthy subject
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Description
7 tubes of 6 ml (42 ml of blood )
Primary Outcome Measure Information:
Title
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)
Description
by flow cytometry.
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers
Time Frame
12 MONTHS
Title
Dosage of cytokines
Time Frame
12 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean olivier ARNAUD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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