Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3B, Multi Center, Open-label Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis

This study is for children and teenagers aged 6 to 17 who have moderate to severe plaque psoriasis. It's a long-term study looking at a medicine called apremilast, also known as Otezla. The main goal is to understand the safety of apremilast over time, including any side effects. Researchers will also keep a close eye on how the medicine affects a child's growth, development, and mood, including any thoughts of self-harm. They will also check how well the medicine works to improve their psoriasis symptoms. If your child has moderate to severe plaque psoriasis and has been taking apremilast, this study might be a way to continue getting treatment and help doctors learn more about the condition and its treatment in young people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Amgen Inc.

Enrolment target

Start

30 Aug 2023

Moderate to Severe Plaque Psoriasis

What is this study about?

This study is designed for children and teenagers between 6 and 17 years old who are living with moderate to severe plaque psoriasis. Psoriasis is a condition that causes red, scaly patches on the skin, and sometimes the joints. This particular study focuses on a medicine called apremilast, which is also known by its brand name, Otezla. It's a long-term study, meaning it will follow participants for an extended period to gather important information.

The main aim of this research is to get a really good understanding of the safety of apremilast when used by young people. This includes carefully recording any side effects that might happen, how often they occur, and how serious they are. The study also aims to see how well apremilast helps improve psoriasis symptoms in young people, looking for clear or almost clear skin. Beyond just skin improvement, the study will also monitor other important aspects of a child's health.

Throughout the study, the research team will regularly check participants' general health, including their weight and height to make sure they are growing well. They will also look at how puberty is progressing, and will ask questions about mood and feelings, specifically looking for any signs of depression or thoughts of self-harm. This comprehensive approach helps doctors understand the overall impact of apremilast on young people's health and development.

Key takeaways

A long-term study for young people (6-17) with moderate to severe psoriasis.
It aims to understand the safety and effectiveness of apremilast (Otezla) over time.
Researchers will monitor growth, puberty, and mood, as well as psoriasis symptoms.
All participants will receive the active medicine, apremilast.
Regular clinic visits and assessments will be part of the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to both boys and girls who are between 6 and 17 years old. The main health requirement is that they must have moderate to severe plaque psoriasis.

For most studies like this, participants need to meet certain other health criteria to make sure it's safe for them to take part and that the study results are clear. While the basic age and condition are listed, a doctor or nurse involved in the study would discuss all the detailed requirements with you and your child to see if they might be a good fit.

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.

Is my child between 6 and 17 years old?
Does my child have moderate to severe plaque psoriasis?
Has my child been taking Apremilast (Otezla) in a previous study?
Is my child able to attend regular clinic visits?
Am I, as a parent or guardian, able to give informed consent for my child to participate?

Answer every question to see your result.

What does participation involve?

If you and your child decide to take part, your child would continue to receive the study medicine, apremilast (Otezla), in tablet form. The dose might be 10mg, 20mg, or 30mg, depending on what the study doctor decides is best.

Throughout the study, your child will have regular check-ups at the study clinic. At these visits, the medical team will measure your child's height and weight to track their growth. They will also routinely check in about their general health, asking about any side effects they might be experiencing. Additionally, there will be specific questionnaires to understand their mood and feelings, and regular checks of their sexual maturity (puberty development). These assessments will happen at the start, every 52 weeks (about once a year), and also if your child needs to leave the study early. The overall duration means ongoing follow-up for the entire study.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as continuing to receive treatment for psoriasis under close medical supervision and contributing to a better understanding of treatments for other young people. However, like all medicines, apremilast can have side effects. The study team will routinely monitor these carefully. There's also the chance the medication might not work as well for your child, or they might experience side effects. You and your child are entirely free to withdraw from the study at any time, for any reason, without it affecting their medical care.

Locations (4)

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

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Unverified
Spain
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Unverified
Czechia
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Unverified
Belgium
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Unverified
Italy

Common questions

What is apremilast (Otezla)?

Apremilast (Otezla) is a medicine that helps to reduce inflammation in the body, which can improve symptoms of psoriasis.

Will my child get a placebo (dummy pill) in this study?

No, this is an 'open-label' study, which means all participants will receive the active medicine apremilast (Otezla), not a placebo.

How often will we need to visit the clinic?

You will have regular visits for check-ups, and some assessments like growth and puberty checks happen yearly, or if your child stops the study early. The exact schedule will be explained by the study team.

What happens if my child has side effects?

The study team will carefully monitor your child for any side effects at each visit, and you can contact them at any time if you have concerns. Their health and safety are the top priority.

What does a 'long-term extension study' mean?

It means this study is continuing to follow young people who may have already been taking apremilast in an earlier study, for a longer period, to gather more information over time.