RecruitingPHASE3INTERVENTIONAL

Remibrutinib Open Label Roll-over Post-trial Access Protocol

This study offers a way for people already taking remibrutinib in a previous Novartis study to continue receiving the medication. It's designed for those who are finding the treatment helpful and can't get remibrutinib outside of a research study, perhaps because it's not yet widely available. The main goal is to keep giving participants their medicine while also gathering important information about its long-term safety. If you're eligible, you could continue treatment for up to three years. This isn't a new treatment trial, but rather a way to continue care for those already benefiting.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

212

Start

16 Apr 2026

Estimated completion

30 Jan 2033

Indication of the Parent Protocol

What is this study about?

This study is called the 'Remibrutinib Open Label Roll-over Post-trial Access Protocol.' In simple terms, it's a way for people who are currently using a medicine called remibrutinib in a Novartis research trial to keep getting it. This is really helpful for participants who are finding the medicine beneficial but can't yet access it through their regular doctor or the health service, as it might still be in the research stages.

The main purpose of this study is twofold: to ensure that people who are benefiting from remibrutinib can continue to receive it, and to collect more long-term information about the medicine's safety. Doctors need to understand how new medicines work over many months or even years, especially to spot any side effects that might only appear after longer use. By letting current users continue, researchers can gather this important data.

Think of it as an extension program. It's not about testing a new dose or trying the medicine for the first time. Instead, it's about continuing the treatment you've already started, at the same dose you've been taking, while carefully watching your health. This study can last for up to three years, or until you and your doctor decide it's no longer needed, or if the medicine becomes available to you in another way.

Key takeaways

This study is for people already using remibrutinib in a Novartis trial.
It helps you continue treatment if it's working and you can't get it elsewhere.
The main goal is to provide continued access and collect long-term safety data.
You'll take the same dose you're currently on.
Participation can last up to three years, with regular clinic visits.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you must have completed a previous remibrutinib study run by Novartis and found the treatment helpful for a skin condition or allergy. You might also be considered if your previous study ended early for reasons other than the medicine not working or safety concerns.

It's important that your study doctor believes remibrutinib is still helping you and that the benefits outweigh any potential risks. Crucially, you must also be unable to get remibrutinib through standard prescriptions or other programs outside of a research study.

However, you won't be able to join if you stopped taking remibrutinib early in your previous study. Also, if you are using certain other medications that could interfere with remibrutinib, you would not be eligible.

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 been in a Novartis remibrutinib study before?
Did you complete that study, or did it end early for non-safety/efficacy reasons?
Do you feel that remibrutinib is currently helping you?
Are you unable to get remibrutinib through a regular prescription or other program?
Are you between 18 and 100 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, there won't be a separate screening process. Once you've agreed to take part, and it's confirmed you meet the study requirements, you can start treatment fairly quickly. Your first visit will be at the study hospital or clinic to ensure you're eligible and to officially begin your participation.

After that, you'll need to return to the study centre at least every 16 weeks (about every four months) to pick up more of your medication. You might need to visit more often if your doctor feels it's necessary or if you have any concerns. You'll continue to take remibrutinib at the same dose and in the same way you did in your previous study.

This study can last for up to three years. However, it will end sooner if your doctor feels the medicine is no longer helping you, if you decide you no longer want to participate, if you become pregnant, if you stop following the study rules, or if you can access remibrutinib outside of the study.

Potential risks and benefits

The main benefit of this study is that you can continue to receive remibrutinib if it's helping you and you can't get it otherwise. This means you might continue to experience the positive effects on your condition. As with any medication, there are always potential risks, including side effects. Your study doctor will discuss these with you in detail. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Novartis Investigative Site
Verified postcode
London, Canada· Recruiting
Novartis Investigative Site
Verified postcode
Québec, Canada· Recruiting
Novartis Investigative Site
Verified postcode
Daegu, South Korea· Recruiting
Novartis Investigative Site
Verified postcode
Suwon, South Korea· Recruiting
Novartis Investigative Site
Verified postcode
Gwangju, South Korea· Recruiting
Novartis Investigative Site
Verified postcode
Seoul, South Korea· Recruiting
Novartis Investigative Site
Verified postcode
Seoul, South Korea· Recruiting

Common questions

What is remibrutinib?

Remibrutinib is a medicine that was being studied in a previous research trial for certain skin conditions and allergies.

Why is this study happening?

This study allows people who benefited from remibrutinib in a previous trial to keep taking it, and helps gather long-term safety information.

Will I get a different dose of the medicine?

No, you will continue to receive remibrutinib at the same dose and in the same way you did in your previous study.

How long will I be in the study?

You could be in the study for up to three years, or until you can get the medicine another way, or if you or your doctor decide it's no longer suitable.

Can I stop participating if I want to?

Yes, you can choose to stop participating in the study at any time, and it will not affect your future medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111 Official trial record

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