Not yet recruitingPHASE3INTERVENTIONAL

Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment

This study is for people who have already been taking a medicine called anifrolumab (also known as Saphnelo) in a previous clinical trial and have noticed that it has helped them. The main aim is to give you continued access to anifrolumab if your doctor believes it is still benefiting you. Throughout the study, doctors will carefully watch for any side effects or problems to make sure the treatment remains safe for you. You will continue to take the medicine in the same way as you did in your original trial. This study helps ensure people who are doing well on anifrolumab can keep receiving it while doctors continue to gather important safety information.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,072

Start

01 Sep 2026

Estimated completion

31 Dec 2032

Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus

What is this study about?

This research study is called a "rollover study." It's designed for people who have already been taking a medicine called anifrolumab (also known as Saphnelo) as part of a previous clinical trial. If your doctor believes that anifrolumab is still helping you with conditions like Systemic Lupus Erythematosus (SLE), Cutaneous Lupus, Myositis, or Systemic Sclerosis, this study allows you to continue receiving the treatment.

The main reasons for this study are twofold: first, to ensure that you can keep getting a treatment that is working for you, and second, to continue monitoring your health very closely. Doctors will be checking for any side effects or changes in your condition throughout the study to make sure the medicine remains safe and beneficial for you. This kind of study helps gather more long-term information about how a medicine works and its safety profile.

Essentially, if you've completed your previous anifrolumab study and your doctor feels the medicine is still making a positive difference, this study offers a way to continue that treatment. You'll take the medicine in the same way you did before, and the healthcare team will be there to support you and monitor your progress every step of the way.

Key takeaways

This study is for people already taking anifrolumab (Saphnelo) in a previous trial.
It allows you to continue receiving the medicine if your doctor thinks it's helping you.
Your safety will be carefully monitored throughout the study.
You'll take the medicine in the same way you did before.
Participants aged 5 to 80 can join, if eligible.

Who may be eligible?

To join this study, you must have already finished a previous clinical trial where you received at least one dose of anifrolumab. Importantly, your study doctor must believe that continuing to take anifrolumab will be more helpful to you than any potential risks.

There are also some rules about contraception, which your doctor will discuss with you to make sure it's safe to take part. You also need to be willing and able to follow the study's instructions and sign a consent form, showing you understand what's involved.

You cannot join if you've had a bad allergic reaction to anifrolumab, or if you are pregnant, breastfeeding, or planning to become pregnant. You also can't take part if you're currently in another research study (apart from your original anifrolumab trial), or if you had serious side effects from the previous anifrolumab study that haven't cleared up. Using certain other medications or planning to have certain vaccinations might also prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I completed a previous anifrolumab study?
Does my doctor believe anifrolumab is still helping me?
Am I willing to use contraception as required, if applicable?
Am I not pregnant, breastfeeding, or planning to become pregnant?
Have I not had a severe allergic reaction to anifrolumab?
Am I not taking part in other drug trials (apart from my original anifrolumab study)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive anifrolumab in the exact same way you did during your original study. This means the medicine will be given to you in the same dose and at the same frequency.

Your first visit for this study can happen as soon as you've completed your final check-ups for your previous study. During the study, your health will be carefully watched. Doctors and nurses will monitor you for any side effects, both serious and less serious ones. This monitoring will continue for up to 12 weeks after your last dose of anifrolumab.

You will continue in the study until certain criteria are met that lead to your doctor deciding it's time to stop the treatment for you. The study team will explain everything in detail, including how long they anticipate you will be involved.

Potential risks and benefits

The main potential benefit of joining this study is that you can continue to receive anifrolumab, a medicine that your doctor believes has been helping you. This allows for ongoing treatment of your condition. As with any medicine, there are potential risks, including side effects from anifrolumab. Your healthcare team will monitor you very closely for any of these, and all serious and non-serious side effects will be recorded. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

Research Site
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Los Angeles, United States
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Fort Lauderdale, United States
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Chicago, United States
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Ann Arbor, United States
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New York, United States
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Charleston, United States
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Graz, Austria
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Graz, Austria
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Ghent, Belgium
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Salvador, Brazil
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Sofia, Bulgaria
Research Site
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Bordeaux, France

Common questions

What is anifrolumab?

Anifrolumab, also known as Saphnelo, is a medicine used to treat certain autoimmune conditions like Systemic Lupus Erythematosus (SLE).

Why is this study called a 'rollover' study?

It's called a rollover study because it allows participants from a previous trial to 'roll over' or continue into this new study to keep receiving the treatment they found helpful.

Will I take the medicine differently in this study?

No, you will continue to receive anifrolumab in exactly the same way (same dose, same frequency) as you did in your previous study.

What conditions is this study for?

This study is for people managing conditions such as Systemic Sclerosis, Cutaneous Lupus, Myositis (E Myopathies), and Systemic Lupus Erythematosus (SLE).

How long will I be in this study?

You will participate in the study for as long as your doctor believes anifrolumab is benefiting you, and until certain study criteria are met for stopping treatment. Your safety will be monitored for 12 weeks after your last dose.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com +1877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.