A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
This study is testing a new medicine, RO7507062, for people living with Systemic Lupus Erythematosus (SLE), also known as lupus. It's a very early stage study, called a 'first-in-human' study, meaning it's one of the first times this medicine will be given to people. The main goals are to check if the medicine is safe, how well people tolerate it, and how it acts in the body. Doctors will be giving different doses to see what effect they have. Another medicine, Tocilizumab, might be used if needed to help with any unexpected reactions. This research is important for finding new ways to treat lupus.
At a glance
What is this study about?
This study is all about a new medicine called RO7507062, which is being investigated as a potential treatment for Systemic Lupus Erythematosus (SLE), often simply called lupus. Lupus is a long-term condition that causes the body's immune system to attack its own tissues, leading to inflammation and damage in many different body parts, such as the joints, skin, kidneys, heart, lungs, and brain.
This is a very early stage study, known as a 'Phase 1' study. This means it's one of the first times this potential new medicine is being given to people. The main aims are to understand its safety: how well people tolerate the medicine and what side effects might occur. Researchers also want to learn how the medicine behaves in the body – for example, how much is absorbed, how long it stays in the system, and what effects it has on the body's systems.
The study will have different parts. In the first part, participants will receive single doses, which will gradually increase. In the second part, participants will receive multiple doses that also increase over time. Another medicine, Tocilizumab, might be used by the doctors if someone develops certain reactions, like a 'cytokine release syndrome,' which is when the immune system has a strong reaction. This is a common precaution in early drug development.
Key takeaways
- This is an early study of a new lupus medicine called RO7507062.
- The main goals are to check the medicine's safety and how it works in the body.
- You need to have been diagnosed with active lupus to potentially qualify.
- Close medical supervision and regular checks will be part of the study.
- You can stop participating at any time if you change your mind.
- Your participation could help advance lupus treatment for others.
Who may be eligible?
To be considered for this study, you would need to have been diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks ago, following specific medical guidelines. You should also have signs of active lupus, which doctors measure using a scoring system. Your blood tests would need to show certain markers linked to lupus, like particular antibodies. If you take steroids or other medicines for lupus, these would need to have been at a steady dose for a certain period before the study starts and stay stable during the study.
There are also reasons why someone might not be able to join. For example, if your lupus is affecting your brain or nerves in a severe or unstable way, or if you've recently had a very serious blood clotting problem called catastrophic antiphospholipid syndrome. You also wouldn't be able to join if your lupus is severely affecting your kidneys and needs powerful treatments, or if you have any other very serious lupus complications that doctors consider severe, such as an active heart inflammation.
Additionally, having severe active autoimmune diseases other than lupus, or any active infections (except for toenail fungus), would prevent you from taking part. The study is open to both men and women between the ages of 18 and 70.
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 I been diagnosed with lupus (SLE) for at least 24 weeks?
- Do I have signs of active lupus?
- Am I between 18 and 70 years old?
- Are my current lupus medications (if any) at a stable dose?
- Do I have any serious or unstable lupus conditions affecting my brain, kidneys, or heart?
- Do I have any active infections other than fungal toenail infections?
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, RO7507062. The study will involve several visits to the clinic for medical checks, blood tests, and to receive the medication. The doctors will closely monitor your health and how you respond to the medicine. This will include keeping a close eye on any side effects you might experience and how your lupus is behaving. You may also need to keep a diary or record certain symptoms at home. You should expect to be in the study for a certain amount of time, which will be fully explained to you before you agree to join. The exact number of visits, tests, and the total duration will be detailed in the study information.
Potential risks and benefits
Locations (24)
- Clinica De La CostaVerified postcodeBarranquilla, Colombia· Recruiting
- Hospital Pablo Tobon UribeVerified postcodeMedellín, Colombia· Recruiting
- Oncomedica S.A.Verified postcodeMontería, Colombia· Recruiting
- Hôpital Saint EloiVerified postcodeMontpellier, France· Recruiting
- Groupe Hospitalier Pitie-SalpetriereVerified postcodeParis, France· Recruiting
- Charité Research Organisation GmbHVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum DuesseldorfVerified postcodeDüsseldorf, Germany· Recruiting
- Hospital Umum SarawakVerified postcodeKuching, Malaysia· Recruiting
- CREA Hospital Mexico AmericanoVerified postcodeGuadalajara, Mexico· Recruiting
- Hospital Angeles De LindavistaVerified postcodeMexico City, Mexico· Recruiting
- Hospital General De MexicoVerified postcodeMexico City, Mexico· Recruiting
- Centre For Human Drug ResearchVerified postcodeLeiden, Netherlands· Completed
Common questions
What is Systemic Lupus Erythematosus (SLE) or lupus?
Lupus is a chronic illness where your body's immune system mistakenly attacks its own healthy tissues and organs, causing inflammation and damage.
What does 'first-in-human study' mean?
It means this is one of the very first times this new medicine is being given to people. It's an early step in testing a new treatment.
Will I know if I'm getting the new medicine?
In some parts of the study, you will receive the new medicine. The study will explain exactly what you would receive if you join.
What is Tocilizumab and why might it be used?
Tocilizumab is another medicine that might be given by doctors if you experience a strong immune reaction called 'cytokine release syndrome' while in the study.
How long will I be in the study?
The total length of time you'd be involved in the study will be clearly explained to you by the study team before you agree to participate.
How to find out more
BP44315 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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