RecruitingPHASE3INTERVENTIONAL

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

This research study is for children and teenagers aged 4 to under 18 who have moderate-to-severe plaque psoriasis. The main goal is to find out how effective and safe a new medicine called zasocitinib is for this condition over a long time. The study has two parts. In the first part, some participants will receive zasocitinib and others will receive a 'dummy' treatment (placebo) for 16 weeks, after which everyone will get zasocitinib. In the second part, all participants will receive zasocitinib from the start. The study can last up to 4 years and 2 months, including regular visits to the study site to check on progress and safety. Initially, only teenagers can join, with younger children joining later once more information from other studies is available. This study could help us understand treatment options for young people with psoriasis.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

110

Start

04 Dec 2025

Estimated completion

24 Jan 2033

Plaque Psoriasis

What is this study about?

This study is looking into a new medicine called zasocitinib for children and teenagers, aged 4 to under 18, who have a skin condition called plaque psoriasis. Psoriasis causes red, scaly patches on the skin, and for those in this study, it's considered 'moderate-to-severe'. The researchers want to learn several things: how well zasocitinib helps improve psoriasis, if it's safe to use, and how young people's bodies react to it over time. This kind of research is important because it helps doctors find better ways to treat conditions that affect young people.

The study is divided into two groups, called 'parts'. In the first part (Part A), some participants will get the new medicine (zasocitinib), while others will get a 'placebo', which looks like the medicine but contains no active ingredients. This helps researchers compare the effects of the actual medicine. After 16 weeks, everyone in Part A will then receive zasocitinib. In the second part (Part B), all participants will receive zasocitinib from the very beginning. By doing this, the researchers hope to get a full picture of the medicine's effects. It's a long-term study, designed to track how participants do over several years.

Initially, only teenagers who meet the study requirements will be able to join. Younger children will be able to participate later, once the researchers have gathered enough information about zasocitinib from other studies and from the teenagers in this study. This careful approach ensures that researchers have a good understanding of the treatment before more children are involved. The results of this study could help doctors in the UK and worldwide understand if zasocitinib could be a useful new treatment option for young people with moderate-to-severe plaque psoriasis.

Key takeaways

This study is testing a new medicine (zasocitinib) for children and teenagers with moderate-to-severe plaque psoriasis.
It aims to understand how well the medicine works and if it's safe over a long period (up to 4 years and 2 months).
Some participants might receive a 'dummy' treatment (placebo) for the first 16 weeks.
Initially, only teenagers (12-17) can join; younger children (4-11) will join later.
Participation involves regular visits to the study site for check-ups and monitoring.
You can stop taking part in the study at any time and for any reason.

Who may be eligible?

To join this study, everyone must have been diagnosed with chronic plaque psoriasis for at least six months and have stable psoriasis that hasn't changed much in the last six months. Your psoriasis also needs to be considered 'moderate-to-severe' by a doctor, covering at least 10% of your body. You should also be someone who your doctor thinks would benefit from stronger treatments like light therapy or other medicines.

There are also age requirements. For the first group of participants (Part A, Cohort 1), you need to be between 12 and 17 years old and weigh at least 40 kilograms (about 6 stone 4 pounds). For younger children (Part A, Cohort 2 and Part B), you would need to be between 4 and 11 years old. Remember, younger children will only be able to join later in the study.

There are also reasons why someone might not be able to join. For example, if you have other types of psoriasis (like erythrodermic or pustular psoriasis), or if you need other systemic treatments for an immune-related condition during the study. You also can't have certain infections like active tuberculosis (TB) or active herpes. The study doctors will carefully check all of these points to make sure the study is safe and appropriate for everyone involved.

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 plaque psoriasis that has been diagnosed for at least 6 months?
Is your plaque psoriasis considered 'moderate-to-severe' by your doctor, covering at least 10% of your body?
Are you between 12 and 17 years old (for initial enrolment), or between 4 and 11 years old (for later enrolment)?
Are you a candidate for stronger psoriasis treatments like light therapy or other medicines?
Do you *not* have other specific types of psoriasis (like erythrodermic) or certain active infections like TB or herpes?
Are you able to attend regular study visits for over 4 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for up to 4 years and 2 months. This includes an initial check-up period of up to 35 days to make sure you're suitable for the study. After that, you'll be on treatment for about 4 years. Finally, there will be a 4-week period to check on your health after your treatment ends.

During the study, you'll visit the study site (which is usually a hospital or clinic) many times. These visits are important so that the study team can monitor your psoriasis, see how the medicine is affecting you, and check for any side effects. Remember, in Part A, some new participants will get either zasocitinib or a dummy treatment (placebo) for the first 16 weeks, and then everyone will get zasocitinib. In Part B, all participants will receive zasocitinib from the start.

The study team will explain everything in detail, including how often you'll need to visit, what tests you might have, and how you'll take the medicine. They're there to support you and answer any questions you have throughout your time in the study.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new medicine (zasocitinib) that might improve your psoriasis if it works well. You'll also receive careful medical attention and regular check-ups from specialists. However, there are also potential risks; for example, zasocitinib might have side effects, or it might not work for everyone. If you receive a placebo at first, your psoriasis might not improve during that initial period. The study team will make sure you understand all known risks before you decide to join. It's really important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Exalt Clinical Research
Verified postcode
Chula Vista, United States· Recruiting
First OC Dermatology Research Inc.
Verified postcode
Fountain Valley, United States· Recruiting
Direct Helpers Medical Center
Verified postcode
Hialeah, United States· Recruiting
Arlington Dermatology
Verified postcode
Rolling Meadows, United States· Recruiting
Apex Clinical Research Center, LLC
Verified postcode
Canton, United States· Recruiting
Wright State Physicians
Verified postcode
Fairborn, United States· Recruiting
Apex Clinical Research Center, LLC
Verified postcode
Mayfield Heights, United States· Recruiting
Medical University of South Carolina
Verified postcode
Charleston, United States· Not yet recruiting
UT Physicians Dermatology - Bellaire Station
Verified postcode
Bellaire, United States· Not yet recruiting
Texas Dermatology and Laser Specialists-San Antonio
Verified postcode
San Antonio, United States· Recruiting
Medical College of Wisconsin
Verified postcode
Milwaukee, United States· Recruiting
Beijing Children Hospital, Capital Medical University
Verified postcode
Beijing, China· Recruiting

Common questions

What is zasocitinib?

Zasocitinib is a new medicine being studied to see if it can help children and teenagers with moderate-to-severe plaque psoriasis.

Will I definitely get the new medicine?

In one part of the study, some participants will get the new medicine and others will get a placebo (dummy medicine) for the first 16 weeks. After that, everyone will get the new medicine. In another part, all participants will get the new medicine from the start.

How long will the study last if I join?

The study could last up to 4 years and 2 months, including time for checks before the medicine starts and a follow-up period after it ends.

Why can't younger children join at the very beginning?

Initially, only teenagers will join. Younger children will be able to join later, after more information about the medicine's safety and effects is known from other studies and from the teenagers already participating.

Can I leave the study if I change my mind?

Yes, absolutely. You are free to withdraw from the study at any time, for any reason, without it impacting your other medical care.

How to find out more

Takeda Contact

medinfous@takeda.com +1-877-825-3327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.