RecruitingPHASE3INTERVENTIONAL

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

This study is an extension to previous research and focuses on the long-term safety of a medicine called ianalumab for people living with Systemic Lupus Erythematosus (SLE), often just called lupus. It's designed for individuals who have already taken part in one of two earlier ianalumab studies. Researchers want to see how well people tolerate ianalumab and monitor for any side effects over a longer period. The medicine is given either monthly or every three months by injection under the skin. This research is important to understand more about ianalumab's safety when used over a longer time for managing lupus.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

550

Start

21 May 2024

Estimated completion

05 Apr 2032

Systemic Lupus Erythematosus

What is this study about?

This study is for people who have lupus, specifically Systemic Lupus Erythematosus (SLE). Lupus is a long-term condition where the body's immune system, which normally fights off infections, mistakenly attacks healthy tissues. This can cause problems in many parts of the body, such as the joints, skin, kidneys, and heart. Our goal in this study is to learn more about a new medicine called ianalumab.

This particular study is a continuation for people who have already been part of one of two earlier studies on ianalumab (known as SIRIUS-SLE 1 or SIRIUS-SLE 2). It will help us understand the long-term safety of ianalumab, meaning we want to see if there are any side effects that might appear over a longer period of time. We'll also check how well people tolerate the medicine, which means how their bodies react to it and if it causes them any discomfort.

Participants will continue to receive ianalumab, given by injection under the skin either once a month or once every three months. There will also be a group who receive a 'placebo' – a dummy treatment that looks like the real medicine but contains no active drug. This helps us to compare the effects of ianalumab more clearly. By researching this over a longer time, we hope to gain valuable information that could help people with lupus in the future.

Key takeaways

This study is an extension of previous research on ianalumab for lupus.
The main goal is to check the long-term safety and tolerability of ianalumab.
Participants will receive ianalumab or a placebo via injection.
It's for people aged 12 to 100 who have completed an earlier ianalumab study.
Regular health checks and monitoring will be part of your participation.
You can stop participating at any time.

Who may be eligible?

To join this study, you must have already completed one of the two previous ianalumab studies (SIRIUS-SLE 1 or SIRIUS-SLE 2) and finished all the treatment in that study. We also need you to agree to take part by signing a consent form. If you're under 18, your parent or guardian will need to sign, and you'll also have to agree yourself.

You cannot join this study if you are pregnant or breastfeeding, or if you plan to become pregnant. Women who could become pregnant must agree to use effective birth control throughout the study and for 6 months after. Men who are sexually active and could father a child must agree to use barrier protection (like condoms). You also can't take part if you have a serious infection needing strong medicines, or if you plan to have certain vaccinations during the study.

The study doctor will also need to believe that continuing with the study medicine would be helpful for your lupus.

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 you already completed all of the first or second SIRIUS-SLE study treatments?
Are you able to provide your agreement to join the study (or is your child's parent/guardian able to, if applicable)?
Are you currently pregnant, breastfeeding, or planning to become pregnant?
Are you using appropriate birth control (if you can become pregnant) or barrier protection (if you're a sexually active male)?
Do you have any serious infections needing strong medication right now?
Are you planning to have certain vaccinations during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the study medicine, ianalumab, as an injection under the skin. This will be given either monthly or every three months. Some participants will receive a placebo, which looks like the study medicine but doesn't contain any active drug. You will have regular visits to the clinic so the study team can check your health, monitor your lupus, and make sure you are tolerating the medicine well. These visits will involve assessments like blood tests and physical examinations.

The total length of your participation is not specified but is for the "long-term" following on from a previous study. The study team will explain the exact schedule of visits and procedures. Throughout your time in the study, you will continue to be closely monitored for any changes in your health or any side effects.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as continued close medical monitoring of your lupus and access to a potential new treatment that may help manage your condition. However, there's no guarantee that the study medicine will work for everyone, or that you'll directly benefit. There are also potential risks, including side effects from the medicine, which will be carefully explained to you. You might also find the regular clinic visits and tests inconvenient. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (127)

Pinnacle Research Group Llc
Verified postcode
Anniston, United States· Recruiting
Providence Medical Center
Verified postcode
Burbank, United States· Recruiting
Advanced Medical Research
Verified postcode
La Palma, United States· Recruiting
Millennium Clinical Trials
Verified postcode
Westlake Village, United States· Recruiting
University of Colorado Denver
Verified postcode
Aurora, United States· Recruiting
Clinical Res Of W Florida
Verified postcode
Clearwater, United States· Recruiting
GNP Research
Verified postcode
Cooper City, United States· Recruiting
IRIS Research and Development
Verified postcode
Plantation, United States· Recruiting
Parris and Associates Rheumatology
Verified postcode
Lawrenceville, United States· Recruiting
Robert A Hozman MD SC
Verified postcode
Skokie, United States· Recruiting
Willow Rheumatology Wellness
Verified postcode
Willowbrook, United States· Recruiting
Accurate Clinical Research
Verified postcode
Lake Charles, United States· Recruiting

Common questions

What is ianalumab?

Ianalumab is a new medicine being studied for people with lupus. We're looking at its long-term safety and how well people tolerate it.

Who can join this study?

You can join if you've already finished one of the two previous ianalumab studies (SIRIUS-SLE 1 or SIRIUS-SLE 2) and meet other health requirements.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but doesn't have any active drug. It helps us compare the effects of the study medicine.

How will the medicine be given?

The study medicine is given as an injection under the skin, either once a month or once every three months.

Can I stop participating if I want to?

Yes, taking part is voluntary. You can leave the study at any time without it affecting your usual medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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