Active not recruitingPHASE3INTERVENTIONAL

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

This UK clinical trial is exploring a new treatment called anifrolumab for adults between 18 and 70 who have moderate to severe Systemic Lupus Erythematosus (SLE), often referred to simply as lupus. The main goal is to find out if this new drug, given as an injection under the skin (subcutaneously), is both safe and effective in improving lupus symptoms when taken alongside patients' current medications. Participants will be randomly assigned to receive either anifrolumab or a placebo (a dummy drug) once a week for about a year. After this, some may continue receiving anifrolumab in an 'open-label' part of the study. This research aims to provide more options for managing lupus.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

367

Start

08 Jun 2021

Estimated completion

06 Nov 2026

Systemic Lupus Erythematosus

What is this study about?

This study is looking into a new medication called anifrolumab as a potential new treatment for Systemic Lupus Erythematosus, or SLE. SLE is a long-term condition that causes the immune system to mistakenly attack healthy tissues, leading to inflammation and damage in various parts of the body. This trial focuses on adults in the UK who are currently living with moderate to severe SLE and are already receiving standard care, such as steroids, antimalarial drugs, or immunosuppressants.

The researchers want to see if adding anifrolumab to a patient's existing treatment plan can improve symptoms and reduce the severity of their lupus. They will also carefully monitor any side effects to make sure the treatment is safe. Participants will be randomly put into one of two groups: one group will receive anifrolumab, and the other will receive a placebo, which looks exactly like the study drug but contains no active medication. This is a common way to test new treatments fairly.

The study is planned to last over a year for each participant, with the main assessment happening after 52 weeks. After this initial period, some participants might have the option to continue receiving anifrolumab in a follow-up phase of the study. This research is important because it could lead to new ways to manage lupus, offering hope for better symptom control and quality of life for people affected by this condition.

Key takeaways

This study tests a new injection, anifrolumab, for moderate to severe lupus.
It's for adults 18-70 already on standard lupus treatment.
Participants will get either anifrolumab or a placebo for about a year.
The drug is given as a weekly injection under the skin.
The study aims to check if anifrolumab is safe and effective.
You can withdraw at any time.

Who may be eligible?

To be able to take part in this study, you would need to be an adult between 18 and 70 years old with a diagnosis of Systemic Lupus Erythematosus (SLE) for at least 24 weeks. Your lupus must be considered moderate to severe, despite already taking standard lupus medications like steroids, antimalarials, or immunosuppressants. Your doctor will use specific medical scales to confirm the severity of your lupus symptoms and ensure you have particular markers in your blood related to SLE.

There are also certain reasons why you might not be able to join. For example, if you have very severe or unstable lupus affecting your brain or kidneys, or if you've had certain serious infections or cancers (other than specific skin cancers or treated cervical cancer) recently, you wouldn't be eligible. Conditions that severely weaken your immune system or certain liver conditions would also prevent participation.

The study team will carefully review your medical history to make sure that taking part is safe for you and that the study results will be clear. They will explain all the criteria in detail during the screening process.

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 18-70 years old?
Do you have a diagnosis of Systemic Lupus Erythematosus (SLE)?
Is your lupus considered moderate to severe?
Are you currently taking standard lupus medications (e.g., steroids, antimalarials, immunosuppressants)?
Have you spoken to your doctor about your general health and existing conditions?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would be involved in this study for approximately 52 weeks, with a potential to extend for an additional 52 weeks. You would be randomly assigned to receive either the study drug (anifrolumab) or a placebo (a dummy treatment) through an injection under your skin, using a pre-filled syringe. These injections would be given once a week for the first 52 weeks.

Throughout the study, you would attend regular clinic visits where the study team will monitor your health, assess your lupus symptoms, and check for any side effects. This will involve physical examinations, blood tests, and questionnaires. The study team will explain the exact schedule of visits and what each visit entails. After the initial 52 weeks, if you choose and are eligible, you might be able to enter an 'open-label' extension where everyone receives anifrolumab for up to another 52 weeks. You are free to withdraw from the study at any time.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new investigational medication that might improve your lupus symptoms or contribute to important medical research. However, there are also potential risks involved, similar to any medical treatment. These could include side effects from the study drug, discomfort from injections, or the burden of extra clinic visits and tests. It's important to remember that not everyone will receive the active drug, and some may receive a placebo. Regardless of your decision, you have the right to withdraw from the study at any point without affecting your standard medical care.

Locations (140)

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

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Birmingham, United States
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Paradise Valley, United States
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Phoenix, United States
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El Cajon, United States
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Fullerton, United States
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Hemet, United States
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La Mesa, United States
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Los Angeles, United States
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Menifee, United States
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Upland, United States
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Aurora, United States
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Brandon, United States

Common questions

What is Systemic Lupus Erythematosus (SLE)?

SLE, or lupus, is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues and organs, causing widespread inflammation and damage.

What is anifrolumab?

Anifrolumab is a new medication being studied for lupus. It's designed to help regulate the immune system. In this study, it's given as an injection under the skin.

Will I definitely get the new drug?

No, this study is 'randomised,' meaning you would have a 50/50 chance of receiving either anifrolumab or a placebo (a dummy drug) for the first year. This helps researchers compare the treatment fairly.

How long does the study last?

The main part of the study lasts for about 52 weeks (one year). If eligible and you choose to, you might then be able to continue receiving anifrolumab for up to another 52 weeks in an extension period.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care or relationship with your doctor.