Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b Multicenter, Randomized, Double-blind, Placebo-controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-81241459 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis

This study is testing a new medicine called JNJ-81241459, designed for people in the UK who have moderate to severe plaque psoriasis. This common skin condition causes red, scaly patches. The main goal is to find out how effective different strengths of this new medicine are at clearing up these skin patches over 12 weeks. Researchers will also be checking if the medicine is safe and what side effects it might have. Some people in the study will receive the new medicine, while others will get a placebo (a dummy pill with no active ingredient). This helps researchers understand the true effects of the new medicine. It's an important step in finding better ways to manage psoriasis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen Cilag International

Enrolment target

100

Start

07 May 2024

Plaque Psoriasis

What is this study about?

If you live with moderate to severe plaque psoriasis, you know how challenging it can be. This condition causes patches of thick, red skin often covered with silvery scales. This study is an important step in trying to find new treatments that could help.

The research is focused on a new medicine called JNJ-81241459. Scientists are testing different doses of this medicine to see how well it works to reduce the psoriasis patches and if it's safe for people to take. This type of study, called a Phase 2b trial, helps researchers get a clearer picture of how the medicine acts in the body before it might be tested in even larger groups of people.

Some participants in the study will receive different doses of the new medicine, while others will receive a 'placebo'. A placebo looks just like the real medicine but contains no active ingredients. This is a common and important way to make sure that any improvements seen are genuinely due to the new medicine and not other factors. The main goal is to see at least a 75% improvement in psoriasis plaques after 12 weeks of treatment.

Key takeaways

This study is testing a new medicine for moderate to severe plaque psoriasis.
It's a Phase 2b study, focusing on how well it works and its safety.
Participants will receive either the new medicine or a placebo.
The main aim is to see a significant improvement in psoriasis after 12 weeks.
You must be an adult (18+) with moderate to severe plaque psoriasis to be eligible.
Your participation could help develop future treatments for psoriasis.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. This study is open to both men and women.

Crucially, you must have been diagnosed with moderate to severe plaque psoriasis. This means your psoriasis is more than just a few small patches; it affects a significant area of your body and has a notable impact on your daily life.

There will be other health checks and requirements to make sure the study is right and safe for you. These will be explained in detail by the study team if you express interest.

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 a diagnosis of plaque psoriasis?
Is your plaque psoriasis considered moderate to severe?
Are you able to attend regular clinic visits?
Are you willing to potentially receive a placebo during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the test medicine (JNJ-81241459 at a 50mg or 200mg dose) or a placebo tablet. You won't know which one you're taking, and neither will the study team – this is called 'double-blind'.

You would have regular visits to the clinic for medical check-ups, to ensure your safety, and to track your skin's progress. These visits would include physical examinations, blood tests, and assessments of your psoriasis. You'll be asked to report any changes in your health or any side effects you experience.

The detailed plan for how long you'd be involved and how many visits you'd need would be fully explained by the study team. They will also outline any follow-up care after the main treatment period.

Potential risks and benefits

Taking part in a clinical study could mean you receive a new medicine that might improve your psoriasis. It also helps advance medical research, potentially leading to new treatments for others in the future. However, like all medicines, the new drug might have side effects that are currently unknown. There's also a chance you could receive the placebo, which means your psoriasis might not improve. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

—
Unverified
France
—
Unverified
Spain
—
Unverified
Poland
—
Unverified
Germany

Common questions

What is 'plaque psoriasis'?

Plaque psoriasis is a common skin condition that causes red, scaly patches on your skin. It's not contagious.

What does 'moderate to severe' mean?

It means your psoriasis covers a noticeable area of your body and significantly impacts your daily life, not just small, isolated patches.

What is a 'placebo'?

A placebo is a 'dummy' tablet that looks like the study medicine but contains no active ingredients. It helps researchers really see if the new medicine works.

Will I know if I'm taking the medicine or the placebo?

No, neither you nor the doctors will know during the study. This helps ensure fair results and is called 'double-blind'.

How long will the study last for me?

The study will track progress specifically for 12 weeks, but your full participation, including visits and follow-up, could be longer. The study team will provide precise details.