Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and ≥120 kg body weight; ADJUST - Phase 4 – efficacy, A randomised, double-blind, controlled, parallel group, multi-centre trial

This research, called ADJUST, is looking into a treatment called Brodalumab (also known as Kyntheum) for adults with moderate to severe plaque psoriasis who weigh 120 kg or more. We want to see if adjusting the dose of Brodalumab can lead to better skin clearing compared to the standard dose. Participants will receive either the adjustable dose or the standard dose over 52 weeks. The main goal is to find out if at least 90% of the skin’s psoriasis clears up by week 40. This study is in its final phase (Phase 4), meaning the treatment is already approved but we are gathering more information about its use in specific groups.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Leo Pharma A/S

Enrolment target

352

Start

06 Jun 2024

Moderate-to-severe plaque psoriasis and a body weight ≥120 kg.

What is this study about?

This study is investigating a medicine called Brodalumab, which is already approved to treat a skin condition called plaque psoriasis. Psoriasis makes patches of skin red, flaky, and itchy. This particular study is for people who have moderate to severe plaque psoriasis and weigh 120 kilograms (about 18 stone 12 pounds) or more.

The main aim of the ADJUST study is to see if giving a flexible, or 'adjustable', dose of Brodalumab works better than the usual, standard dose. We want to know if this adjustable dose helps clear up the psoriasis more effectively for people in this weight group. We'll be looking at how much the psoriasis improves, focusing on whether 90% or more of the skin affected by psoriasis clears up, over a period of 52 weeks.

By running this study, we hope to understand if a different way of giving Brodalumab could be more beneficial for some patients with psoriasis, especially those who are heavier. This kind of research helps doctors decide the best way to use treatments for different people. While Brodalumab is already available, this study helps us fine-tune its use.

Key takeaways

Tests Brodalumab, an existing psoriasis medicine.
Focuses on people with moderate to severe psoriasis who weigh 120 kg or more.
Compares an adjustable dose against the standard dose.
Aims for at least 90% skin clearing by week 40.
Lasts 52 weeks with regular health checks.
Helps understand the best way to use Brodalumab for some patients.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You should have moderate to severe plaque psoriasis, which means your psoriasis is quite widespread or affects important areas of your body.

Another important requirement is that you must weigh 120 kilograms (about 18 stone 12 pounds) or more. This study is specifically designed to look at how Brodalumab works in people within this weight range.

Both men and women can take part. There may be other specific health checks or conditions that make someone unsuitable for the study, but these will be discussed in detail by the study team.

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 moderate to severe plaque psoriasis?
Do you weigh 120 kilograms (about 18 stone 12 pounds) or more?
Are you able to attend regular study appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned by chance to receive either the adjustable dose of Brodalumab or the standard dose. It's 'double-blind,' meaning neither you nor your study doctor will know which treatment you are getting. You might also receive a placebo, which looks just like the study drug but contains no active medicine, to help us compare the effects fairly. You will be taking the study medication for 52 weeks.

Throughout the study, you'll have regular visits to the clinic. At these visits, doctors and nurses will assess your psoriasis, including how much of your skin is affected and how severe it is. They will also check other areas like your genitals if they are affected by psoriasis. You'll answer questionnaires about how psoriasis affects your daily life. These assessments will happen at specific times, such as Week 40 and Week 52. There will be follow-up appointments and monitoring to check your health and how the treatment is working.

Potential risks and benefits

Participating in research can offer potential benefits, such as receiving close medical attention and access to a potential new dosing strategy for your psoriasis that might be more effective for you. However, there are also potential risks, including side effects from the medication, which will be fully explained before you decide to join. As with all medical studies, there's always a chance the treatment might not work for you, or you could receive a placebo and your psoriasis may not improve. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

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Unverified
Czechia
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Unverified
Hungary
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Unverified
Italy
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Unverified
Germany
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Unverified
Belgium
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Unverified
Spain
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Unverified
Greece
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Unverified
Poland
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Unverified
France

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition that causes red, scaly, and sometimes itchy patches on your skin.

What is Brodalumab (Kyntheum)?

Brodalumab, also known as Kyntheum, is a specific type of medication used to treat moderate to severe plaque psoriasis.

What is a 'flexible' or 'adjustable' dose?

It means the amount of medicine you receive might be changed based on how your body is responding, rather than always being the same dose.

Why is weight important for this study?

Researchers want to understand if a different dosing strategy for Brodalumab works better for people who weigh 120 kg or more, as medication doses can sometimes be affected by body weight.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the adjustable dose, the standard dose, or a placebo, to keep the results fair and unbiased.