Cenerimod is a tablet taken once per day, which works by keeping lymphocytes in the lymph nodes and reducing inflammation, so stopping the immune system from attacking your body.^{1, 2, 3}

In previous clinical studies, in total more than 550 people living with systemic lupus erythematosus (SLE) took cenerimod.^{3, 4}

Patients and their clinical study medical team will not know if they are receiving cenerimod or a placebo during the OPUS clinical study. This will be decided by a computer at random. This randomization is very important to eliminate bias during the study and ensure objective results. This will help the researchers understand whether the potential investigational drug really works or not.

In Phase 3 trials, testing an investigational drug against a placebo is essential to confirm the investigational drug’s true effectiveness and safety. Without a placebo group, we can’t be certain if improvements are due to the investigational drug or other factors. This careful comparison ensures that only truly effective treatments reach the market, benefiting future patients with therapies that work reliably and safely.⁵

In addition to the investigational drug or a placebo, you will continue to receive your current SLE treatment during your participation in the OPUS clinical study. You will also have regular health assessments, close monitoring, and immediate support from your clinical study medical team during the OPUS clinical study. At the end of the OPUS clinical study, you’ll have the opportunity to know what study treatment you receive during your participation (cenerimod or placebo).

At the end of the OPUS clinical study, you may be offered the choice to enter another clinical study in which you will be given cenerimod (no more placebo). This clinical study is referred to as an “Open-label extension” study because you and the clinical study medical team know that you are receiving cenerimod.

There are no guarantees that the investigational drug you receive during the clinical study will work for you.

Your health and safety are our top priority throughout the OPUS clinical study. If the investigational drug, together with your current SLE treatment, doesn’t seem to be effective for you, you and your medical team can discuss at any time whether it’s best for you to continue or discontinue your participation in the OPUS clinical study.

Your participation in the OPUS clinical study, you are helping to advance scientific understanding and maybe helping other patients to get better care in the future.

Your overall participation in the OPUS clinical study is about 20 months, including approximately 16 visits to the clinic or hospital, which can be broken down as follows:

• An initial screening period of up to 2 months to go through some routine tests and a physical examination performed by your clinical study medical team. These tests make sure that taking part in the OPUS clinical study is right for you and that you meet the safety and health requirements to participate in the clinical study (e.g. you have moderate to severe SLE).
• A treatment period of 12 months, during which you will receive the investigational drug to take as a tablet once per day, every day (either cenerimod or a placebo, you won’t know which) and have monthly in-person checkups at the clinic or hospital.
• A follow-up period of 6 months after you stop taking the investigational drug, and which includes 2 clinic or hospital visits and phone calls. You may also be able to enter the Open-label extension clinical study instead of entering the follow-up period.

At the end of the 12-month treatment period, you may be offered the choice to enter another clinical study in which you will be given cenerimod (no more placebo). This clinical study is referred to as an “Open-label extension” study because you and the medical team know that you are receiving cenerimod. Your participation could last an additional 1 to 3 years. This extended treatment phase is designed to further support your health and help us understand more about the potential long-term benefits of cenerimod.

If you choose not to continue in the Open-label extension clinical study, then you will go back to your regular care routine before the OPUS clinical study began, and your OPUS medical team will follow your health for an additional 6 months.

Researchers will analyze all the OPUS clinical study results from everyone who participated worldwide. If the results prove that cenerimod is an effective treatment for SLE, it will then be submitted for review and approval, potentially making it available to the wider group of people living with SLE.

The OPUS clinical study has been designed so that many approved SLE medications can continue to be taken by the participants. If your current SLE treatment(s) are on this list, you will continue to receive them during your participation in the OPUS clinical study.

So that the results of the investigational drug can be fairly evaluated, it is important that you take your current SLE treatment for the entire duration of your participation in the OPUS clinical study.

The first priority of any clinical study is the safety of those taking part in it. You will receive timely medical attention for any issue of concern or side effects with the investigational drug that arise either at the clinic or at the hospital, or with your own treating/primary physician.

You must let your OPUS medical team know immediately of any side effect or medical issue you are having while taking part in the OPUS clinical study. It’s important to investigate whether the side effect or medical issue is related to the investigational drug, your underlying SLE, or another cause.

All study-related visits, tests, and investigational drug are provided to you at no cost. In addition, reimbursement for study-related travel and time may be provided if you qualify depending on country-specific law. You can ask your medical team about the possibility of reimbursement for study-related travel and time when you enroll in the OPUS clinical study.

Participating in a clinical study often means adding new routines to your day-to-day life. You will need to attend regular clinic or hospital visits, and complete health assessments or questionnaires. Most appointments will require traveling to visit the clinical study site, which may impact your schedule. However, you will receive ongoing health monitoring and support from the OPUS medical team, who will work closely with you to minimize any disruptions.

Our goal is to ensure your comfort and safety throughout your participation in the OPUS clinical study, and you will have a dedicated medical team to answer any questions and address any challenges you may have.

It can be helpful to speak to someone else living with SLE who has taken part in a clinical study before, to get an idea about the impact of it on your daily life. Speak to your doctor or a local patient organization and ask them if they can put you in touch with someone about this.

You always have the right to stop participating in the OPUS clinical study at any time without giving a reason or an explanation. This is your personal choice. This will not affect your regular SLE care in any way.

If you decide you would like to stop participating, please speak to your OPUS medical team immediately.

OPUS and all clinical studies follow strict regulations to ensure that the private, medical and personal information of participants is protected at all times.

Before you take part in a clinical study, you will be given an information sheet to read and an informed consent form to sign, which includes a detailed explanation of how your private, medical and personal data will be collected, used, and protected.

After the last participating person completes the OPUS clinical study, it takes several months for the researchers to analyze all the information collected from all participants around the world.

Once the results are available, we will share a summary of them with all the participants in the OPUS clinical trial, via their OPUS medical teams.