Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of RO7303509 in Patients with Systemic Sclerosis

This research is testing a new medication, RO7303509, for a condition called Systemic Sclerosis. Systemic Sclerosis causes the body's immune system to attack its own tissues, leading to hardening of the skin and sometimes internal organs. The main goals of this study are to check if the new medicine is safe for people to take, how much of it the body can handle, and how the body uses and gets rid of it when different amounts are given. It's an early-stage study, meaning it's one of the first times this medicine is being given to people. The information gathered will help decide if the medicine can be tested further in larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Genentech Inc.

Enrolment target

Start

19 Feb 2024

Systemic Sclerosis

What is this study about?

This study is all about a new potential medicine, known as RO7303509, for a condition called Systemic Sclerosis. Systemic Sclerosis is a long-term illness where your body's immune system mistakenly attacks its own tissues, causing them to get thick and hard. This can affect your skin, blood vessels, and sometimes even internal organs.

Researchers want to carefully test this new medicine to make sure it's safe for people. They will also look at how your body handles the medicine – how it gets into your system, how it's used, and how it eventually leaves your body. They'll be giving different amounts (doses) of the medicine to see what's the best and safest amount.

This is an early-stage study, which means it's one of the very first times this medicine is being given to people. The information they gather will be really important. It will help them understand if the medicine has too many side effects or if it works well enough to be tested in more people and for longer periods in the future. It's a key step in developing new treatments for Systemic Sclerosis.

Key takeaways

This is an early study testing a new medicine (RO7303509) for Systemic Sclerosis.
The main goals are to check if the medicine is safe and how your body handles it at different doses.
Participation involves regular clinic visits for checks, blood tests, and receiving the study medicine.
You must have Systemic Sclerosis and be 18 years or older to be considered.
You will be closely monitored, and you can withdraw from the study at any time.

Who may be eligible?

To join this study, you must have Systemic Sclerosis. You also need to be at least 18 years old – there's no upper age limit, meaning older adults can also take part if they meet other health requirements.

Beyond these basic points, there will be other health checks to make sure the study is safe for you. For example, doctors will likely check your other medical conditions and any medicines you are already taking. These details help make sure that joining the study won't put your health at risk.

It's important to remember that even if you meet the main age and condition requirements, the study team will need to do a full health check to see if you are a good fit. They want to make sure the study is right for you, and that you are right for the study.

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.

Do you have Systemic Sclerosis?
Are you 18 years old or older?
Are you able to attend regular clinic appointments?
Are you willing to potentially take a new, untried medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, RO7303509. You'd likely start with a lower dose, and if it's safe, the amount might slowly increase over time. This is called 'multiple-ascending doses'.

Your participation would involve regular visits to the study clinic. During these visits, doctors and nurses will monitor your health very closely. This will include blood tests to measure the medicine in your body and check for side effects, possible urine tests, and physical examinations. They'll also ask you lots of questions about how you're feeling and any changes you notice.

The total length of time you'd be in the study will be explained in detail by the study team. It typically involves a screening period to confirm you're eligible, a period where you take the medication and have regular check-ups, and then a follow-up period after you stop the medication to ensure you're well. The exact number of visits and the overall duration will depend on the study design.

Potential risks and benefits

Potential benefits of joining this study include close medical monitoring and the chance to receive a new medicine that might help manage your Systemic Sclerosis, although this is not guaranteed as it's an early-stage study. Potential risks could include side effects from the new medicine, which are not yet fully known, or discomfort from medical procedures like blood tests. You will be given a document that lists all known potential risks. Remember, you have the right to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Germany
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Unverified
Belgium
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Unverified
France
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Unverified
Spain
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Unverified
Portugal
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Unverified
Poland

Common questions

What is Systemic Sclerosis?

Systemic Sclerosis is a long-term condition where your body's immune system attacks its own tissues, causing them to harden. It can affect your skin and sometimes internal organs.

What does 'Phase I' or 'Human Pharmacology' mean?

It means this is one of the first times this new medicine is being given to people. The main aim is to check its safety and how the body handles it, not yet to see if it cures the disease.

Will I get the actual medicine or a dummy pill?

Because this study is looking at safety and doses, it's very likely everyone will receive the active medicine (RO7303509) at different dose levels. The study team will explain this fully.

How long will I be in the study?

The exact duration will vary. It usually involves a screening period, a treatment period with regular visits, and a follow-up period after you stop the medicine. The study team will tell you the specific timeline.

Can I stop participating if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without having to explain why. This will not affect your regular medical care.