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Completed

NCT Number: NCT03370627

Effect of Anti-CD303 Antibodies in Autoimmune Diseases

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

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Key information

Conditions

Immune Disease Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  1. in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA)

    Time frame: Baseline

  2. in vitro determination of the level of type I interferons by ELISA immunoassay method in patients treated or not with immunosuppressive or immunomodulatory treatment.

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

Registry information

Official study title

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

Acronym: ANTI-CD303

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2017
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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