Effect of Anti-CD303 Antibodies in Autoimmune Diseases

NCT03370627 | Completed

• 2 other identifiers: 2017_232017_A02244-49
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Conditions

Immune Disease

Keywords

Autoimmune Diseases; Plasmacytoid Dendritic Cells; Type I Interferons; Antibodies; Anti-CD303

Outcome Measures

Primary Outcomes (1)

• in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.

  Baseline

Secondary Outcomes (2)

• 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

Study Arms (1)

Patient

EXPERIMENTAL

Biological: Monoclonal anti-cd303 antibody

Interventions

Monoclonal anti-cd303 antibody BIOLOGICAL

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.

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Laboratoire français de Fractionnement et de Biotechnologies: collaborator

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Conditions

Immune System Diseases; Autoimmune Diseases

Study Officials

• David Launay, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: December 20, 2017
• Primary Completion: May 25, 2019
• Study Completion: May 25, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

FR (1)