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

NCT ID: NCT03322618

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2019-09-17

Brief Summary

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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.

Detailed Description

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Conditions

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Axial Spondyloarthritis (axSpA) Ankylosing Spondylitis (AS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SpA HLA-B27 +,

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

7 tubes of 6 ml (42 ml of blood )

SpA HLA-B27-

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

7 tubes of 6 ml (42 ml of blood )

healthy subject

Group Type ACTIVE_COMPARATOR

blood samples

Intervention Type BIOLOGICAL

7 tubes of 6 ml (42 ml of blood )

Interventions

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blood samples

7 tubes of 6 ml (42 ml of blood )

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jean olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01705-48

Identifier Type: OTHER

Identifier Source: secondary_id

2017-33

Identifier Type: -

Identifier Source: org_study_id

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