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Study on Adjustable Brodalumab Dosage for Patients with Moderate-to-Severe Plaque Psoriasis Weighing 120 kg or More

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called brodalumab in individuals with moderate-to-severe plaque psoriasis, a skin condition that causes red, scaly patches. The study is specifically for those who weigh 120 kg or more. Brodalumab is administered as a solution for injection using a pre-filled syringe. The trial will compare two different dosing regimens of brodalumab: an adjustable dose and a standard dose. There is also a placebo group involved in the study.

The purpose of the study is to evaluate how well the adjustable dosing regimen of brodalumab works compared to the standard dosing regimen in reducing the symptoms of psoriasis. Participants will receive treatment over a period of 52 weeks. Throughout the study, the effectiveness of the treatment will be assessed by observing changes in the severity and extent of psoriasis symptoms.

Participants will be monitored regularly to track their progress and any changes in their condition. The study aims to determine if the adjustable dosing regimen can provide better control of psoriasis symptoms compared to the standard dosing regimen. This information could help improve treatment options for individuals with moderate-to-severe plaque psoriasis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of brodalumab or a placebo. The medication is provided as a solution for injection in a pre-filled syringe.

    The initial dosage is 210 mg of brodalumab, administered once a week for the first three weeks.

  2. Step 2

    Adjustment phase

    After the initial phase, the dosage may be adjusted based on the response to the treatment.

    The goal is to compare the effects of an adjustable dosage regimen with a standard treatment regimen.

  3. Step 3

    Maintenance phase

    Following the adjustment phase, the treatment continues with the maintenance dosage.

    The standard maintenance dosage is 210 mg every two weeks.

  4. Step 4

    Evaluation phase

    The primary goal is to achieve a 90% reduction in the Psoriasis Area and Severity Index (PASI) score by Week 40.

    Secondary goals include achieving a static Physician’s Global Assessment (sPGA) score of 0 or 1 and a PASI 100 response by Week 52.

  5. Step 5

    Completion of trial

    The trial is expected to last for 52 weeks.

    The final assessments will be conducted to evaluate the overall effectiveness and impact on quality of life.

Who can join the trial?

6 criteria

  • You must have signed and dated a form that shows you agree to participate in the study before any study-related procedures begin.
  • You need to be between 18 and 74 years old at the time of the screening.
  • You should have been diagnosed with chronic plaque psoriasis for at least 6 months before joining the study. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • Your body weight must be at least 120 kg at the time of screening.
  • You must have moderate-to-severe plaque psoriasis, which means that the psoriasis affects at least 10% of your body surface area (BSA) and you have a Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and baseline. PASI is a tool used to measure the severity of psoriasis.
  • You should not have any signs of active or hidden tuberculosis, which is a serious lung infection, according to the local standard of care for patients starting a biologic treatment. Biologic treatment is a type of medication that targets specific parts of the immune system.

Who cannot join the trial?

4 criteria

  • Having a body weight of less than 120 kg (about 265 pounds).
  • Not having moderate-to-severe plaque psoriasis, which is a skin condition that causes red, scaly patches on the skin.
  • Being under the age of 18 or over the age of 65.
  • Being part of a vulnerable population, which means needing special protection or care.
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Investigated drugs

Brodalumab is a medication used in this clinical trial to treat moderate-to-severe plaque psoriasis. It works by blocking certain proteins in the body that can cause inflammation and lead to the symptoms of psoriasis. The trial is comparing two different ways of using this medication: an adjustable dosage regimen and a standard treatment regimen. The goal is to see which method is more effective in reducing psoriasis symptoms in patients who weigh 120 kg or more.

What is already known about the treatment

Brodalumab – Brodalumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe plaque psoriasis, particularly in individuals weighing 120 kg or more. The medication works by blocking a specific protein in the body that contributes to inflammation and the rapid growth of skin cells, which are characteristic of psoriasis. Brodalumab is classified as a monoclonal antibody, targeting the interleukin-17 receptor to help reduce the symptoms of psoriasis.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition that causes the rapid growth of skin cells, leading to the formation of scales and red patches that can be itchy and sometimes painful. It is the most common form of psoriasis and typically appears as raised, inflamed, and scaly patches on the skin. These patches, or plaques, are often found on the elbows, knees, scalp, and lower back, but they can appear anywhere on the body. The condition can vary in severity, with some individuals experiencing only minor patches, while others may have more extensive skin involvement. The progression of plaque psoriasis can be unpredictable, with periods of remission and flare-ups. Factors such as stress, infections, and certain medications can trigger or worsen the symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509668-11-00Protocol codeLP0160-1329Estimated enrolment384 patientsSponsorLeo Pharma A/S

sourced from the EU Clinical Trials Register and site verification

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