Effect of Anti-CD303 Antibodies in Autoimmune Diseases

Immune Disease Clinical Trial

— ANTI-CD303  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370627
• Other study ID #: 2017_23
• Secondary ID: 2017_A02244-49
• Status: Completed
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: May 25, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Immune Disease
• Immune System Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.		Baseline
Secondary	in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA)		Baseline
Secondary	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