- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03370627
Effect of Anti-CD303 Antibodies in Autoimmune Diseases (ANTI-CD303)
Effect of Monoclonal Anti-cd303 on the Inhibition of Type I Interferon Secretion in the Peripheral Blood of Patients With 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France
- Hôpital Claude Huriez, CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA)
Time Frame: Baseline
|
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.
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Launay, MD,PhD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017_23
- 2017_A02244-49 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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