RecruitingPHASE1INTERVENTIONAL

Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants

This research study is looking at a new medicine called surovatamig for adults with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). These are both conditions where your immune system mistakenly attacks your own body. We are in the first stage of testing (Phase 1), which means the main goal is to check how safe the medicine is at different doses and how well your body handles it. We'll also be learning how much of the medicine gets into your system and what it does there. Participants will receive the medicine as an injection under the skin. The study will help us understand if surovatamig could be a promising new treatment option in the future. We are inviting people aged 18 to 65 to take part if they meet certain criteria related to their condition and previous treatments.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

02 Dec 2025

Estimated completion

27 Jun 2028

Rheumatoid Arthritis Systemic Lupus Erythematosus

What is this study about?

This study is about a new medicine called surovatamig, which is being investigated for people living with rheumatoid arthritis (RA) or systematic lupus erythematosus (SLE). Both RA and SLE are long-term conditions where your body's immune system, which normally fights off infections, starts to attack healthy parts of your own body by mistake. This can cause pain, swelling, and damage to joints and other organs.

This is an early-stage study (called Phase 1), meaning it's one of the first times this medicine is being tested in people. The most important things we want to find out are whether surovatamig is safe and if people can tolerate it well. We also want to understand how your body handles the medicine – how it's absorbed, distributed, and eventually leaves your system. This helps us work out the right dose to use in future studies.

The medicine is given as an injection under the skin. We are looking for adult participants, aged between 18 and 65, who have been diagnosed with either RA or SLE. By carefully studying surovatamig in this early stage, we hope to learn if it could eventually become a helpful new treatment option for these conditions.

Key takeaways

This is an early-stage study (Phase 1) for a new medicine called surovatamig.
The study is for adults aged 18-65 with rheumatoid arthritis or systemic lupus erythematosus.
The main goals are to check the medicine's safety, how it's handled by the body, and what dose is best.
Surovatamig is given as an injection under the skin.
You might be able to continue some of your existing treatments, depending on the study rules.

Who may be eligible?

To join this study, you must be between 18 and 65 years old. If you have rheumatoid arthritis (RA), you need to have been diagnosed according to specific medical guidelines and have certain markers in your blood, called autoantibodies. Your RA should be moderately or severely active, meaning you have a certain number of tender and swollen joints, and you must not have responded well to at least two previous strong RA medicines (called b/tsDMARDs) or couldn't tolerate them after trying standard treatments (csDMARDs). You can continue some of your regular RA medicines during the study, like a stable low dose of oral steroids or certain other arthritis medications.

If you have systemic lupus erythematosus (SLE), you also need to have been diagnosed using specific medical guidelines and have certain autoantibodies in your blood. Your SLE should be moderately or severely active. You will not be able to join if you do not meet these specific criteria for your condition.

The study team will carefully check your medical history, current health, and specific test results to make sure it's safe for you to take part and that the study is right for you. They will explain everything in detail.

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 between 18 and 65 years old?
Do you have a diagnosis of Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)?
Have you not responded well to, or tolerated, previous treatments for your condition?
Are you able to attend regular clinic visits for injections and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study medicine, surovatamig, as an injection under your skin. The study will involve groups of participants receiving either a single dose that gradually increases, or a dose that steps up over time. You will have regular visits to the clinic for health checks, blood tests, and other assessments to monitor your health and how the medicine is affecting your body. These may include checks on your joints if you have RA, or symptoms related to SLE. The total duration of your involvement in the study will be explained in full detail by the study team.

Potential risks and benefits

Like any new medicine, surovatamig may have potential side effects, which the study team will monitor very closely. You might not directly benefit from taking part, but the information we gather will help us understand if this medicine could help others in the future. The study team will explain all known risks and what to expect. Participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (33)

Research Site
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Birmingham, United States· Withdrawn
Research Site
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Fullerton, United States· Recruiting
Research Site
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St Louis, United States· Not yet recruiting
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Allen, United States· Recruiting
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Mesquite, United States· Recruiting
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Birtinya, Australia· Recruiting
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Clayton, Australia· Recruiting
Research Site
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Edegem, Belgium· Recruiting
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Leuven, Belgium· Not yet recruiting
Research Site
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Liège, Belgium· Recruiting
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Porto Alegre, Brazil· Not yet recruiting
Research Site
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Salvador, Brazil· Not yet recruiting

Common questions

What is surovatamig?

Surovatamig is a new medicine being tested for rheumatoid arthritis and lupus. This study is an early step to see how safe and effective it might be.

What does 'Phase 1 study' mean?

Phase 1 means it's an early study in people. The main goal is to check the medicine's safety, how the body handles it, and to find the right dose.

How will I receive the medicine?

The medicine, surovatamig, will be given as an injection under your skin.

Can I continue my regular medicines?

Some regular medicines for RA or SLE might be allowed during the study, but this will be carefully checked by the study team. You will need to tell them about all your current medications.

Am I paid to participate?

This information isn't provided here, but the study team will be able to explain any compensation for your time or travel expenses.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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