AuthorisedTherapeutic confirmatory (Phase III)Interventional

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

This study, called SUNFLOWER, is looking into a new treatment for systemic lupus erythematosus (lupus) called Saphnelo. Saphnelo is given as an injection under the skin once a week. The main goal is to find out how many people taking Saphnelo achieve a state called 'remission' after a year, meaning their lupus symptoms are much better controlled. This study is for adults who haven't tried certain other powerful lupus medications before. It's a 'Phase III' study, which means it's a later stage of testing, designed to confirm if the treatment is effective and safe. They'll also check how long people stay in remission and how their symptoms change over time. It's an important step in finding better ways to manage lupus.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

Start

02 Jun 2026

Systemic lupus erythematosus

What is this study about?

This study, known as SUNFLOWER, is designed to investigate a new medication called Saphnelo for people living with Systemic Lupus Erythematosus, often just called lupus. Lupus is a long-term (chronic) condition that causes the body's immune system to mistakenly attack its own tissues and organs. This can lead to a wide range of symptoms, including tiredness, joint pain, skin rashes, and problems with kidneys or other organs.

Saphnelo is a medicine given as an injection just under the skin, once a week. The main purpose of this study is to see how well Saphnelo helps people achieve 'remission'. In lupus, remission means that the disease is much less active, and symptoms are well-controlled, essentially giving people a break from the disease's effects. Doctors will be checking to see how many participants reach this state of remission after receiving Saphnelo for about a year.

This is a 'Phase III' trial, which means it's a key stage in testing a new medicine. At this point, researchers are looking to confirm that the treatment is both safe and effective over a longer period. They will also be tracking other important details, such as how long people stay in remission, if their symptoms improve, and if any side effects occur. Understanding these factors helps figure out if Saphnelo could be a valuable new option for managing lupus.

Key takeaways

This study is testing a new lupus treatment called Saphnelo.
It aims to see if Saphnelo helps people achieve and stay in lupus remission.
Participation involves weekly injections for a year and regular check-ups.
It's for adults who haven't used certain strong lupus medicines before.
You could get access to a new treatment, but also face potential side effects.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older, with a diagnosis of systemic lupus erythematosus (lupus).

An important part of who can join is that you haven't previously taken certain types of strong medicines for your lupus. Specifically, you shouldn't have used medications that suppress your immune system (unless it was for a very short time and not for lupus) or 'biologic' medicines, which are a newer class of targeted drugs. This helps researchers understand the true effect of Saphnelo without other powerful treatments interfering.

Both men and women can take part in this study. The study also has other detailed medical requirements that a doctor involved in the trial would discuss with you to make sure it's the right fit.

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.

Are you 18 years old or older?
Have you been diagnosed with systemic lupus erythematosus (lupus)?
Have you NOT taken certain immune-suppressing drugs or 'biologic' medicines for lupus?
Are you able to commit to weekly injections and regular clinic visits for about a year?
Are you comfortable with the idea of being part of a medical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Saphnelo, as an injection under your skin once a week for a full year (52 weeks). There will be regular visits to the study clinic during this time. At these visits, doctors and nurses will check your health, ask about your symptoms, and do various assessments. These might include blood tests, urine tests, and physical examinations to see how you are responding to the treatment and to monitor for any side effects. After the 52 weeks of receiving the medication, there will likely be follow-up visits to see how you are doing, even after you've stopped treatment. The total duration of your participation, including follow-up, could extend beyond the 52 weeks of treatment.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment before it's widely available, which might improve your lupus symptoms. It also contributes valuable information that could help others with lupus in the future. However, there are potential risks, as with any medication. Saphnelo might cause side effects, some of which could be mild, while others could be more serious or unexpected. The exact nature of these risks would be fully explained before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Italy
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Unverified
France

Common questions

What is systemic lupus erythematosus (lupus)?

Lupus is a chronic illness where your immune system mistakenly attacks your body's own healthy tissues, causing inflammation and damage to organs like joints, skin, kidneys, and more.

What is Saphnelo?

Saphnelo is the new medicine being tested in this study. It's given as an injection under the skin once a week and aims to help control lupus symptoms.

What does 'remission' mean for lupus?

In lupus, remission means your disease activity is very low, and your symptoms are well controlled, often allowing you to feel much better and have a higher quality of life.

Is this a new medicine or one already used for lupus?

Saphnelo is a newer medicine, and this Phase III study is to confirm its effectiveness and safety before it might become more widely available for lupus treatment.

How long will I be in the study if I join?

You'll receive the study medicine for about a year (52 weeks), but your participation, including follow-up visits, might continue beyond that time.