FAQs

People have different reasons for choosing to taking part in clinical studies. These may relate to some or all of the following:

• Contributing to advances in medicine that may help others with the same condition in the future
• Having your condition monitored by experts in that field of medicine at regular study visits
• Learning more about your own health
• Potential access to an investigational therapy that may not otherwise be available

You will not pay to participate in this study. You will not have to pay for any study drug, tests or medical procedures you receive as part of this study. The cost of any other drugs or medical procedures (outside this study) that you may use/need during your participation will not be covered.

You are likely to be able to continue using any current steroid, antimalarial, or immunosuppressant medications that you are currently taking to manage your SLE, so long as your dosage has not changed recently. The study doctor will check your full medication history with you at screening. You will be advised if you need to stop or change dosing for any of your medications, including those you take for managing SLE.

The investigational drug interacts with your immune system. Under normal circumstances your immune system works to protect your body by detecting and removing harmful biologic agents that do not belong to your body. Biologic agents could be microorganisms such as viruses or bacteria. When your immune system responds, it attacks these invaders and generally causes fever and inflammation. Inflammation is your body's way of protecting itself when something harmful happens. It sends more blood and immune cells to the area to help heal it, causing redness, warmth, swelling, and sometimes pain.

In SLE your immune system mistakenly attacks healthy tissues of your own body. This causes inflammation (called auto-inflammation) in multiple tissues, causing symptoms and ultimately damage to your body. This is called an “autoimmune” disease.

The investigational drug in PHOENYCS FLY is a type of drug called a “biologic”. This biologic is designed to reduce inflammation or further action of your immune cells.

In this study, we are trying to find out if the investigational drug will help to reduce the excessive auto-inflammation in your body and thereby reduce the symptoms and damage SLE causes to it.

In clinical research, it is common for an investigational drug to be compared with a placebo. A placebo does not contain any medically active ingredients and is not expected to have any therapeutic effect on a medical condition. Including a placebo group in a clinical study is the best way to help the study investigators:

• Assess the effect of the investigational drug
• See if any side effects are caused by the investigational drug

In the PHOENYCS FLY Study, all participants will continue with their standard SLE medications as well as either the investigational drug or placebo.

If you complete the study treatment period in PHOENYCS FLY, you may be able to take part in a 2-year extension study that is testing the same investigational drug. All participants in the extension study will receive the investigational drug; there is no placebo group. If you are not able to or do not wish to take part in the extension study, you will stop receiving your study treatment, and the study doctor will advise you on next steps for managing your SLE.

You should discuss risks and benefits with the study doctor before making any decision about taking part. You can find full details about risks and benefits in the Informed Consent Form.


A known impact of taking biologic drugs can be a change in how your immune system functions, and a potential for increased risk of infections. You will be tested for a respiratory infection known as tuberculosis (TB) at the start and end of study treatment. Throughout the study, you will be checked for signs and symptoms of TB.

Once all participants have completed the study, and all the collected data have been analyzed, a “lay summary” of the results will be published. This lay summary will be written in easy-to-understand language and will outline the key study findings. All participants will be able to access this. It may be several years after you have completed the study before the summary is available.

You can leave the PHOENYCS FLY Study at any time without this affecting your standard healthcare and without having to give a reason. You will be asked to attend at least one further study center visit after you finished your study treatment to ensure the study team can follow-up on your health and well-being.

The study will run at study centers across the globe on behalf of the study Sponsor. A Sponsor is the person, company, institution, group, or organization that oversees or pays for a clinical study and collects and analyzes the data. UCB is the Sponsor of the PHOENYCS FLY Study.

Your data will be handled as strictly confidential, and your identity will not be revealed in any publication or report generated from this study.

All your personal data we collect that can identify you will be “coded”. This means that the study doctor removes any part of the personal data that could identify you (like your name) and replaces it with a code. This code is usually a number. Using a code helps researchers keep your information confidential.

However, direct access to your uncoded personal data will be given to authorized personnel (eg, staff monitoring the study, auditors) from UCB or its representatives and to members of Regulatory Authorities and Independent Ethics Committees (IECs), so that they can verify that the information collected for the study is accurate.

No. You can contact the study center to find out more about participating without any commitment. Contacting your local study center does not mean that you must or will be able to join the study.