A Mono-center, Prospective Study for the Collection of Blood Samples From Patients With Systemic Lupus Erythematosus (SLE) and volunteers in good health for research purposes.

nd Development of orally available drug candidate molecules to modulate the
dysregulated immune system. These drug candidates have the potential to address
a wide range of chronic auto-immune diseases, affecting millions of people
worldwide and include type I interferon-mediated diseases, like systemic lupus
erythematosus (SLE).
In response to an unknown trigger, the immune system may attack the body*s own
tissues or organs leading to life threatening conditions for some patients.
Treatment for autoimmune diseases generally focuses on reducing immune system
activity. Most of these diseases have no cure and the most serious conditions
require lifelong treatment to ease symptoms.
One of the auto-immune diseases, Ermium is targeting is SLE.
Lupus is a systemic autoimmune disease in which abnormal antibodies directed
against healthy tissues and organs cause disease and damage. Inflammation
caused by lupus can affect many organ systems, including skin, joints, kidneys,
blood cells, brain, heart and lungs.
Systemic lupus is a heterogeneous disease affecting people in different ways.
For some, lupus can be mild and limited for others, it may cause disease and
damage in critical organs and may be life threatening.
Most people with lupus have disease characterized by episodes or flares when
signs and symptoms worsen for a while, then improve or even disappear
completely for a time.
The global incidence is 3,41 million people(1). It is estimated that there are
200.000-250.000 patients in Europe(2) living with lupus and about1,5 million of
people in the United States(3).
In this study, Ermium aims to collect blood samples from SLE patients to
investigate the immune system to support the discovery and development of new
molecules for the potential treatment of SLE and other autoimmune diseases, and
to evaluate the effect in vitro of these new molecules on the dysregulated
immune system. In vitro assays on whole blood, isolated blood cells,
serum/plasma may be performed to study the immune system as well as the immune
response induced by those new molecules as potential new treatment option for
SLE. Different (cell-based) assays may be run using a range of immunological
techniques, but no genetic testing will be performed.

The primary objective of this study is to collect blood samples (maximum of 150
mL per study visit ) from women and men who have SLE and from volunteers in
good health to study the immune system of SLE patients and to investigate new
potential molecules.

Enrolled subjects will provide one standard venous blood draw performed under
the responsibility of a trained investigator.
Subjects may choose to participate in this study only once or may be allowed to
attend multiple visits (every 3 months) if required.
Whole blood samples will be shipped ambient on the day of collection for
further processing and analysis to the laboratory site of the Sponsor in France.
Research protocols may be performed at the Sponsor*s lab using fresh blood or
isolated immune cells, and remaining serum/plasma as well as whole blood and
isolated immune cells will be aliquoted and stored for further exploratory
research work. Some studies will require fresh samples while others can be
performed using frozen and thawed blood cells.
No genetic testing will be performed, nor will blood samples be used for
transfusion or stem cell related applications.
Since the blood samples will be used for exploratory Research activities, it is
not possible to estimate the exact sample size for the study. However, at this
time, it is projected that samples from less than 150 subjects will be required
to complete the entirety of the research work.
The study duration is approximately 3 years, but may be ended earlier if
sufficient samples are collected.
All study staff will be well trained on the study protocol and have current
certifications for the roles they will perform in this study.
Study subjects will be consented, enrolled, and have blood drawn in a private
area of the study center. Subjects will be given ample time to decide to
participate after all their questions have been answered.
The investigator will be allowed to delegate the ICF to a trained staff member
(i.e study nurse).

one blood sample of 150 ml will be taken.

The possible risks with blood drawing are pain, bleeding, fainting, bruising,
infection and/or hematoma (blood clot under the skin) at the injection site. If
the subjects develops bruising this will go away after a couple of days and
can be treated with warm compresses.