ANTI-CD303: Effect of Anti-CD303 Antibodies in Autoimmune Diseases

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT03370627

Collaborator

Laboratoire français de Fractionnement et de Biotechnologies (Industry)

138

Enrollment

Location

Arm

17.1

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The pathogenic role of type I interferons (IFNs) in the development of different autoimmune diseases has been extensively described in the literature. Since plasmacytoid dendritic cells (pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed by the pDCs.

The hypothesis leading to the realization of this study is to observe, in vitro, an inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB Group, which could reduce the inflammatory response and improve patients with autoimmune disease

Condition or Disease	Intervention/Treatment	Phase
Immune Disease	Biological: Monoclonal anti-cd303 antibody	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effect of Monoclonal Anti-cd303 on the Inhibition of Type I Interferon Secretion in the Peripheral Blood of Patients With Autoimmune Diseases

Actual Study Start Date :

Dec 20, 2017

Actual Primary Completion Date :

May 25, 2019

Actual Study Completion Date :

May 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient	Biological: Monoclonal anti-cd303 antibody Addition of monoclonal anti CD303 antibodies or not (control) on 2 blood samples of the same patient, to which 10 μl of CpG (20 μg / ml) are added in order to activate plasmacytoid Dendritic Cells and to induce the secretion of Type I interferons.

Arm

Intervention/Treatment

Experimental: Patient

Biological: Monoclonal anti-cd303 antibody

Addition of monoclonal anti CD303 antibodies or not (control) on 2 blood samples of the same patient, to which 10 μl of CpG (20 μg / ml) are added in order to activate plasmacytoid Dendritic Cells and to induce the secretion of Type I interferons.

Outcome Measures

Primary Outcome Measures

in vitro determination of the level of type I interferons by immunoenzymatic ELISA method. [Baseline]

Secondary Outcome Measures

in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA) [Baseline]
in vitro determination of the level of type I interferons by ELISA immunoassay method in patients treated or not with immunosuppressive or immunomodulatory treatment. [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study data collection procedures
Patient followed in the department of internal medicine of CHU Lille
Patient with one of the following autoimmune disease, defined according to international criteria: systemic lupus erythematosus, systemic sclerosis, Gougerot-Sjögren syndrome and idiopathic thrombocytopenic purpura
Being socially insured