Study details
Around 450
participants
56
weeks
15
study center visits
Over 20
countries
What is the aim of the PHOENYCS FLY Study?
The aim of this study is to find out whether adding an investigational drug to standard SLE medication over 48 weeks can improve SLE symptoms. The study will also assess the tolerability as determined by how a participant reacts to the investigational drug.
What happens during the study
If you want to join the study, you will first go to a screening visit to see if the study is appropriate for you and check that you meet the entry criteria. If the study doctor thinks you are a suitable candidate and you continue to meet the entry criteria, you will start receiving your assigned study treatment (either the investigational drug or a placebo) at the next visit. During the study, you will have regular visits to the study center to check on your health and how you are responding to the study treatment.
Which study treatment will I receive?
If enrolled in the study, you will continue to take any standard medications you are currently receiving for SLE AND you will be randomly assigned to receive either the investigational drug or placebo over 48 weeks. Randomly means by chance, like flipping a coin or pulling names out of hat. A placebo looks like the investigational drug but does not contain any medically active ingredients.
For every two participants who receive the investigational drug, one participant will receive placebo. This means that if you participate, you will have a 67% chance of receiving the investigational drug and a 33% chance of receiving placebo. Neither you nor the study team will know which you are receiving.
How will I receive the study treatment?
You will receive your assigned study treatment (either investigational drug OR placebo) once every 4 weeks as an intravenous infusion. This means that the study treatment will flow through a needle placed into one of your veins (usually in your arm) by a member of the study team. You will have the infusions at your study center visits.
How long will the infusions take?
Your first infusion will take around 2 hours. After that, each infusion will take around 1 hour. After each infusion, you will stay at the study center for an additional hour, so the study staff can check how you are doing.
How long will the study last?
Participation in the study will last around 56 weeks in total.
1 visit • Around 2 weeks
13 visits • 12 infusions • 48 weeks
1 visit • 6 weeks
or
1 visit every 4 weeks • 2 years
56 weeks in total
*Open-label extension
Most study center visits will take around 3–4 hours. During this time, you will undergo various tests and assessments. The purpose of these is to understand how your body is responding to study treatment and check on your health. The tests/assessments include (but are not limited to) the following:
Blood and urine samples
Small amounts of your blood and urine will be analyzed for various safety and health checks
Electrocardiogram (ECG)
A painless test to measure the electrical activity of your heart
Physical examination
A check of your overall physical health
Questionnaires
You will answer questions about your symptoms, and how SLE affects you and your daily life. You will receive an electronic device (tablet), so you can do this at home
Vital signs
Measurements of your blood pressure, body temperature, breathing and pulse rate