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

Primary Purpose

Immune Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Monoclonal anti-cd303 antibody
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Immune Disease focused on measuring Autoimmune Diseases, Plasmacytoid Dendritic Cells, Type I Interferons, Antibodies, Anti-CD303

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Claude Huriez, CHU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 7, 2017
Last Updated
August 26, 2020
Sponsor
University Hospital, Lille
Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
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1. Study Identification

Unique Protocol Identification Number
NCT03370627
Brief Title
Effect of Anti-CD303 Antibodies in Autoimmune Diseases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Laboratoire français de Fractionnement et de Biotechnologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Disease
Keywords
Autoimmune Diseases, Plasmacytoid Dendritic Cells, Type I Interferons, Antibodies, Anti-CD303

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Monoclonal anti-cd303 antibody
Intervention Description
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 Outcome Measure Information:
Title
in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA)
Time Frame
Baseline
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Launay, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez, CHU
City
Lille
Country
France

12. IPD Sharing Statement

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Effect of Anti-CD303 Antibodies in Autoimmune Diseases

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