Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

OptIMMize-1: A Randomized, Active-controlled, Efficacy Assessor-blinded Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

This study, called OptIMMize-1, is researching new medicines (risankizumab and ABBV-066) for young people aged 6 to under 18 who have plaque psoriasis that is moderate to severe. It compares these new medicines to a treatment already in use called Stelara (ustekinumab). The main goal is to see how much the skin patches improve after 16 weeks and if the skin becomes clear or almost clear. Researchers will also check how safe the medicines are and how the body handles them. This is a Phase 3 study, meaning it's a larger study to confirm the benefits and safety before a medicine might be made widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

Start

14 Jul 2023

Plaque Psoriasis.

What is this study about?

Imagine your skin has red, scaly patches – that's plaque psoriasis. For young people, it can be really tough. This study, called OptIMMize-1, is looking into new ways to help. Researchers want to find out how safe and effective two new medicines, risankizumab and ABBV-066, are for children and teenagers between 6 and under 18 years old who have moderate to severe plaque psoriasis. They are comparing these new medicines to a treatment that doctors already use, called Stelara.

The main aim of the study is to see if these new medicines can significantly clear up the skin patches and reduce the problems caused by psoriasis. They'll measure how much the skin improves after 16 weeks of treatment. They will also be looking closely at how these medicines affect the young people's quality of life, like how their psoriasis impacts their daily activities and how much itching they experience. This isn't just about skin; it's about helping young people feel better overall.

Studies like this are really important. They help doctors understand which treatments work best for different people and if new treatments are safer or more effective than what’s currently available. By taking part, young people could help advance medical knowledge and potentially help others with psoriasis in the future.

Key takeaways

Targets young people aged 6 to under 18 with moderate to severe plaque psoriasis.
Compares two new medicines (risankizumab, ABBV-066) to an existing treatment (Stelara).
Aims to see how much skin clears up and if daily life improves.
It's a Phase 3 study, a key step for new medicines.
Participation involves regular clinic visits and medication.

Who may be eligible?

This study is looking for children and teenagers with moderate to severe plaque psoriasis. This means their psoriasis affects a noticeable part of their body and significantly impacts their life.

Participants must be between 6 and under 18 years old. Both boys and girls can take part in this study.

There might be other health requirements or previous medication history that could affect whether someone can join. If you're interested, the study team will ask detailed questions to see if you meet all the specific criteria.

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 between 6 and under 18 years old?
Do you have plaque psoriasis?
Is your psoriasis considered moderate to severe?
Are you generally in good health otherwise?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either one of the new study medicines (risankizumab or ABBV-066) or an existing treatment (Stelara). You wouldn't get to choose which one you receive; it's decided randomly, like flipping a coin. You wouldn't know which treatment you are getting, and neither would the doctors assessing your skin, to help make the results fair.

Taking part would involve regular visits to the clinic for check-ups, assessments of your skin, and to receive your medication. The study team would also track how you're feeling and how your psoriasis is affecting your life, using questionnaires. There would be a main treatment period, and then a re-treatment phase for some participants. The total duration of your involvement in the study would be explained by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving expert medical care and access to new treatments before they are widely available. Your psoriasis might improve significantly. However, there are also potential risks, including side effects from the medication you receive, which will be fully explained to you. The treatment you get might also not work as well as hoped. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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
Spain
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Unverified
Poland

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition that causes red, scaly patches on the skin, often on the elbows, knees, scalp, and lower back.

What does 'moderate to severe' mean for psoriasis?

It means the psoriasis affects a significant area of the body or has a big impact on a person's daily life, causing a lot of discomfort or embarrassment.

What is a 'Phase 3' study?

Phase 3 is an important step in testing new medicines. It involves a larger number of people to confirm how effective and safe a new treatment is before it can be considered for wider use.

Will I know which medicine I am getting?

No, in this type of study, neither you nor the doctors assessing your skin will know which particular medicine you are receiving. This helps make the study results as fair and unbiased as possible.

What does it mean if the study says 'active-controlled'?

It means the new medicines are being compared against an active medicine that is already approved and used for treating psoriasis, rather than against a dummy treatment (placebo).