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Effect of Anti-CD303 Antibodies in Autoimmune Diseases (ANTI-CD303)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370627
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Laboratoire français de Fractionnement et de Biotechnologies
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 20, 2017
Actual Primary Completion Date : May 25, 2019
Actual Study Completion Date : May 25, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. in vitro determination of the level of type I interferons by immunoenzymatic ELISA method. [ Time Frame: Baseline ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370627


Locations
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France
Hôpital Claude Huriez, CHU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
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Principal Investigator: David Launay, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03370627    
Other Study ID Numbers: 2017_23
2017_A02244-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Autoimmune Diseases
Plasmacytoid Dendritic Cells
Type I Interferons
Antibodies
Anti-CD303
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs