Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants with Systemic Lupus Erythematosus

This research is investigating a new medication called mosunetuzumab for individuals living with Systemic Lupus Erythematosus, often just called lupus. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. The main goals are to find out if the medicine is safe to use and how well the body can handle it. Researchers will also look at how the medicine moves through the body and what effects it has on the disease. There isn't much information available yet, but it's an important step in developing new treatments for lupus. It's open to adults aged 18 and over, of any gender.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

24 Jun 2024

Systemic Lupus Erythematosus (SLE)

What is this study about?

This study is all about a new potential medicine called mosunetuzumab, designed for people who have Systemic Lupus Erythematosus, or SLE. SLE is a long-term condition that causes the body's immune system to mistakenly attack its own tissues, leading to inflammation and damage in different parts of the body, like the joints, skin, kidneys, and heart. Finding new and better treatments for lupus is really important to help manage symptoms and improve quality of life for those affected.

This particular study is in its very early stages, often called a 'Phase I' trial. This means it's one of the first times this new medicine is being tested in humans. The main goal isn't necessarily to see if it cures lupus yet, but rather to understand some basic, crucial things. Researchers want to find out if the medicine is safe when given to people and if there are any side effects. They also want to understand how the body processes the medicine, for example, how much of it gets into the bloodstream and how long it stays there, and what immediate effects it might have.

By carefully studying these early details, scientists can decide if it's safe and promising enough to move on to larger studies. This kind of research is a vital step in developing any new medication, ensuring that potential future treatments are as safe and effective as possible for patients with conditions like lupus.

Key takeaways

This is an early study of a new medicine, mosunetuzumab, for lupus.
The main goals are to check if the medicine is safe and how the body reacts to it.
It's open to adults aged 18 and over, of any gender.
Participation would involve clinic visits, blood tests, and receiving the study medicine.
Joining could give you access to a new experimental treatment and help future lupus patients.
There are potential risks, and the medicine's effectiveness for lupus symptoms is not yet known.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. This study is open to both men and women.

Because this is a very early study and there isn't much detailed information available yet, it's likely that there will be other specific health requirements or conditions that you would need to meet. For instance, sometimes these studies require you to have a certain type or level of lupus, or you might need to be in good general health otherwise.

It's important to talk to your doctor or the study team to get the full list of who can and cannot join. They will be able to check if your personal health situation matches what they are looking for in participants.

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?
Do you have Systemic Lupus Erythematosus (SLE)?
Are you able to attend regular clinic visits and follow study instructions?
Are you comfortable potentially taking a new, experimental medicine?
Are you willing to have blood tests and other health checks?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves isn't fully available yet for this early-stage study. However, typically in a Phase I study like this, you can expect:

* **Visits:** You would likely need to attend the study clinic for several visits, which could include some overnight stays, especially in the beginning. These visits would be for receiving the study medicine, having blood tests, and health checks. * **Assessments:** You would have regular blood tests to check how the medicine is affecting your body and how it's moving through your system. You'd also have physical exams and discussions about any symptoms or side effects you might be experiencing. * **Medication:** You would receive the study medicine, mosunetuzumab, probably as an injection under the skin, as it's described as "subcutaneously administered." You would be carefully monitored after receiving it. * **Follow-up:** After you finish receiving the main treatment, there would be follow-up visits to ensure you are well and to continue monitoring any lingering effects or side effects. * **Total Duration:** The total time you would be involved in the study could range from a few weeks to several months, depending on the study design and the number of doses given.

Potential risks and benefits

Potential benefits of joining could include getting access to a new medicine for lupus that is not yet widely available, and helping doctors understand more about lupus and potential future treatments. However, because this is an early-stage study, we don't know if the medicine will help your lupus symptoms or if it will cause side effects. There's always a risk that new medicines could have unexpected side effects, and some might be serious. Before deciding, you will be given all the information about possible risks and benefits, and you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Poland

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.

What is mosunetuzumab?

It's a new medicine being studied as a potential treatment for lupus. This study is looking at its basic safety and how it works in the body.

What does 'Phase I' mean for a study?

Phase I means it's an early study, often one of the first times the medicine is given to people. The main aims are to check if it's safe and how the body handles it.

Will I get better if I join this study?

This early study primarily aims to check safety and how the medicine works, rather than if it improves symptoms. We don't know yet if it will help your lupus.

Can anyone with lupus join this study?

You need to be an adult (18 or older). There will be other specific health requirements, so you'll need to discuss your full medical history with the study team to see if you're suitable.