Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Evaluation of Safety, Tolerability, and Pharmacodynamic Effects of Topically Applied SUDO-286 in Psoriasis

This research study is looking at a new cream, SUDO-286, designed for people with a skin condition called plaque psoriasis. Psoriasis causes red, scaly patches on the skin. In this early-stage study, called Phase I, we're mainly focused on understanding if the cream is safe for people to use and if it causes any unwanted side effects when applied to the skin. We also want to learn how the cream works in the body and what effects it might have. This type of study is important for medicine development, as it helps us decide if a new treatment is promising enough to test in larger groups of people later on.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sudo Biosciences Limited

Enrolment target

Start

24 Jun 2024

Plaque Psoriasis

What is this study about?

This study is about a new cream called SUDO-286, which is being developed to treat a common skin condition known as plaque psoriasis. Psoriasis makes skin cells grow too quickly, leading to thick, red, and scaly patches. Doctors and scientists are always looking for better ways to manage this condition, and new treatments like SUDO-286 could offer fresh hope.

In this early stage of testing, often called a Phase I study, the main goal is to check the cream's safety. When a new medicine is first given to people, it's really important to make sure it doesn't cause serious problems or uncomfortable side effects. We also want to see how easily people can use the cream and how well their body reacts to it.

Further, the study will look at how SUDO-286 works in the body, understanding its effects on the skin and the disease itself. This detailed information helps researchers decide if SUDO-286 is safe and effective enough to move on to bigger studies with more people in the future. It's a crucial step in bringing new treatments to those who need them.

Key takeaways

This study is testing a new cream, SUDO-286, for plaque psoriasis.
It's an early-stage study focused on safety and how the cream affects the body.
Participants must be 18 years old or over and have plaque psoriasis.
The cream is applied to the skin, and you'll have regular clinic visits.
There are potential benefits (new treatment) and risks (unknown side effects).
You can withdraw from the study at any time.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit for joining.

This study includes both men and women, so your gender does not affect whether you can participate. The researchers will be looking for people who specifically have 'plaque psoriasis', which is the most common type of psoriasis.

There might be other health requirements or things that could prevent you from joining, which the study team will discuss with you. They'll need to check your full medical history to make sure the study is right for you and that you're safe to take part.

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 plaque psoriasis?
Are you comfortable applying a cream to your skin regularly?
Are you willing and able to attend regular clinic visits?
Do you understand that this is a research study with potential benefits and risks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the cream, SUDO-286, to apply to your skin. The study team will tell you exactly how and when to use it. You will have regular visits to the clinic so that doctors and nurses can check on your health and how the cream is affecting your psoriasis.

During these visits, they might take measurements, ask you questions about how you're feeling, and examine your skin. These checks help them understand if the cream is safe and if it's having any effect. There will also be follow-up visits after you stop using the cream to make sure you remain well. The exact number of visits and the total length of time you'll be involved in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new treatment that isn't widely available yet, which could help your psoriasis. You'll also be closely monitored by medical professionals, which means any changes in your health will be noticed quickly. However, there are potential risks, as SUDO-286 is a new cream and might cause side effects that we don't fully know about yet. These could include skin irritation at the application site or other reactions. You have the right to withdraw from 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
Germany

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition where skin cells grow too quickly, leading to thick, red, scaly patches on the skin.

What is a Phase I study?

A Phase I study is an early stage of testing a new medicine in people. The main goals are to check if it's safe, how well people tolerate it, and how it works in the body.

Will I get the actual cream being tested?

Yes, if you join this study, you will be given the new cream, SUDO-286, to apply to your skin.

What does a 'topically applied' cream mean?

It means the cream is designed to be put directly onto the skin, rather than being swallowed or injected.

Can I stop participating in the study if I change my mind?

Absolutely, you have the right to leave the study at any time, for any reason, without it affecting your medical care.