Effect of Anti-CD303 Antibodies in Autoimmune Diseases

Not Applicable

Completed

• Conditions: Immune Disease
• Interventions: Biological: Monoclonal anti-cd303 antibody

• Registration Number: NCT03370627
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-12
• Study Start: 2017-12-20
• Primary Completion: 2019-05-25
• Study Completion: 2019-05-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Exclusion Criteria

• Overlapping syndrome with another autoimmune disease
• Age ≤18 years
• Pregnant or nursing women
• People in emergencies
• Person incapable of consent
• Persons deprived of liberty
• Persons without social security cover

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient	Monoclonal anti-cd303 antibody	-

Primary Outcome Measures

Name	Time	Method
in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.	Baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France