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Study on Proactive Drug Monitoring with Secukinumab, Ixekizumab, or Guselkumab for Patients with Moderate-to-Severe Psoriasis

Verified siteRegistered drugNo placebo
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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 treatment of moderate-to-severe psoriasis, a skin condition that causes red, itchy, and scaly patches. The study will use three different medications: secukinumab, ixekizumab, and guselkumab. These medications are known as biologics, which are treatments made from living organisms or their cells. They are administered as a solution for injection, either in a pre-filled pen or syringe.

The purpose of the study is to compare two approaches to using these biologics: proactive therapeutic drug monitoring (TDM) and routine care. Proactive TDM involves regularly checking the levels of the drug in the body to adjust the dose if necessary, while routine care follows the standard dosing schedule without such monitoring. The study will last for 18 months, during which participants will receive one of the biologics and be monitored for their response to the treatment.

Throughout the study, participants will have regular check-ups every three months to assess their skin condition and overall health. The main goal is to see if proactive TDM is as effective as routine care in maintaining control over psoriasis symptoms. Participants will also be monitored for any side effects or changes in their condition, such as new or worsening joint pain, which can sometimes occur with psoriasis. The study aims to provide valuable information on the best way to use these biologics for treating moderate-to-severe psoriasis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will have already been diagnosed with moderate-to-severe psoriasis and treated with one of the specified medications for at least six months.

    The patient will have signed a consent form before any study procedures begin.

  2. Step 2

    Treatment administration

    The patient will continue receiving their current medication, which could be one of the following: secukinumab, ixekizumab, or guselkumab.

    These medications are administered as a solution for injection using either a pre-filled pen or syringe.

  3. Step 3

    Monitoring and assessments

    The patient's condition will be monitored through regular assessments every three months over an 18-month period.

    The primary goal is to maintain disease control, measured by a specific score called PASI, which evaluates the severity of psoriasis.

  4. Step 4

    Evaluation of treatment effectiveness

    The study will assess changes in the patient's PASI score from the start of the study to the end of the 18-month period.

    Additional evaluations will include quality of life assessments using tools like DLQI_R and SF-36, which measure the impact of psoriasis on daily life.

  5. Step 5

    Monitoring side effects

    The study will track any new symptoms or worsening of existing conditions, such as arthritis.

    Any serious side effects or reactions to the medication will be documented.

  6. Step 6

    Cost and satisfaction analysis

    The study will analyze the cost of treatment and the patient's satisfaction with the medication using specific questionnaires.

    The effectiveness of the treatment in terms of cost and patient satisfaction will be evaluated.

Who can join the trial?

4 criteria

  • Adults aged 18 years or older can participate.
  • You must have a documented diagnosis of **psoriasis**, which is a skin condition, confirmed by a qualified skin doctor (dermatologist).
  • You should have been receiving treatment with one of the following medications for at least 6 months: **secukinumab**, **ixekizumab**, or **guselkumab**. These are specific medicines used to treat psoriasis.
  • You need to sign a written consent form, which is a document that shows you agree to take part in the study and understand what it involves, before any study activities begin.

Who cannot join the trial?

8 criteria

  • Patients who do not have moderate-to-severe psoriasis cannot participate. Psoriasis is a skin condition that causes red, itchy, and scaly patches.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have other significant health conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of allergic reactions to the study medications cannot participate.
  • Patients who have used certain medications recently that might interfere with the study cannot participate.
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Investigated drugs

  • Secukinumab

    is a medication used in the treatment of moderate to severe psoriasis. It works by targeting a specific protein in the immune system that contributes to the inflammation and skin symptoms associated with psoriasis. In this trial, secukinumab is being evaluated to see if monitoring its levels in the blood can help maintain better disease control compared to standard care.

  • Ixekizumab

    is another treatment option for moderate to severe psoriasis. It functions by blocking a protein that plays a key role in the inflammatory process of psoriasis. The trial is investigating whether proactive monitoring of ixekizumab can provide similar or better results in managing psoriasis symptoms compared to routine treatment practices.

  • Guselkumab

    is a biologic medication used for treating moderate to severe psoriasis. It targets a specific part of the immune system to reduce inflammation and improve skin conditions. The study aims to determine if regular monitoring of guselkumab levels can help achieve sustained control of psoriasis symptoms as effectively as the usual care methods.

What is already known about the treatment

  • Secukinumab

    Secukinumab is administered as an injection under the skin. It is currently used in the treatment of moderate-to-severe psoriasis and is well-documented in medical literature. The medication works by blocking a specific protein in the immune system called interleukin-17A, which plays a role in inflammation and the development of psoriasis. It is classified as a biologic medication, specifically a monoclonal antibody.

  • Ixekizumab

    Ixekizumab is given as an injection under the skin. It is used to treat moderate-to-severe psoriasis and is recognized in medical literature for its effectiveness. The drug targets and inhibits interleukin-17A, a protein involved in inflammatory processes that contribute to psoriasis. It belongs to the class of biologic medications known as monoclonal antibodies.

  • Guselkumab

    Guselkumab is administered via injection under the skin. It is indicated for the treatment of moderate-to-severe psoriasis and is well-established in medical literature. The medication works by blocking interleukin-23, a protein that contributes to inflammation and the development of psoriasis. It is classified as a biologic medication, specifically a monoclonal antibody.

Investigated diseases

Psoriasis – Psoriasis is a chronic skin condition characterized by the rapid growth of skin cells, leading to thick, red, scaly patches on the skin. It is an autoimmune disorder, meaning the body's immune system mistakenly attacks healthy skin cells. The disease can vary in severity, with some individuals experiencing only minor patches, while others may have widespread lesions. Psoriasis can also affect the joints, leading to a condition known as psoriatic arthritis. The progression of 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 ID2023-509637-39-00Estimated enrolment210 patientsSponsorUniversitair Ziekenhuis Gent

sourced from the EU Clinical Trials Register and site verification

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