CClinicalTrials.gg
CompletedNCT03370627ANTI-CD303Updated Aug 27, 2020

Effect of Anti-CD303 Antibodies in Autoimmune Diseases

An interventional study of Monoclonal anti-cd303 antibody in Immune Disease, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-27.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Immune Disease

Keywords

  • Autoimmune Diseases
  • Plasmacytoid Dendritic Cells
  • Type I Interferons
  • Antibodies
  • Anti-CD303
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    Patient

    Biological: Monoclonal anti-cd303 antibody

Interventions

  • BiologicalMonoclonal 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.

05

What researchers measure

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

06

Study locations

1 site
  • Hôpital Claude Huriez, CHU
    Lille, France
07

Registry details

Key details

Study ID
NCT03370627
Lead sponsor
University Hospital, Lille
Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Responsible party
Sponsor
First posted
Dec 12, 2017
Start date
Dec 20, 2017
Primary completion
May 25, 2019
Completion
May 25, 2019
Last update
Aug 27, 2020

Study contacts

David Launay, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion