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Study on Guselkumab for Patients with Moderate-to-Severe Plaque Psoriasis

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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 a skin condition called moderate-to-severe plaque psoriasis. This condition causes red, scaly patches on the skin that can be itchy and painful. The study is testing a treatment called Guselkumab, which is given as an injection. Guselkumab is a type of protein that helps to reduce inflammation and improve the appearance of the skin. The study will also use a placebo, which looks like the treatment but does not contain any active medicine.

The purpose of the study is to find out if people who respond very well to Guselkumab can maintain control of their psoriasis with less frequent doses. Participants will receive injections of Guselkumab every 16 weeks over a period of time. The study will monitor how well the treatment works in keeping the skin clear and how long the effects last. Participants will be randomly assigned to different groups, and neither the participants nor the researchers will know who is receiving the actual treatment or the placebo.

The study will last until week 68, and participants will have regular check-ups to assess their skin condition. The main goal is to see how many people achieve a significant improvement in their psoriasis by the end of the study. This research aims to provide more information on how to effectively manage moderate-to-severe plaque psoriasis with Guselkumab.

The research process

The trial runs in 4 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 is confirmed to have moderate-to-severe plaque-type psoriasis. This is determined by a PASI score greater than 10 or affected body surface area greater than 10%, and a DLQI score greater than 10 at the start of the study.

  2. Step 2

    Initial treatment phase

    The patient begins treatment with guselkumab, administered as a subcutaneous injection. The dosage is 100 mg per injection.

    The initial phase involves regular administration of the medication to establish control over the psoriasis symptoms.

  3. Step 3

    Maintenance phase

    Once the initial treatment phase is completed, the patient enters the maintenance phase. During this phase, the treatment intervals are extended to every 16 weeks.

    The goal is to maintain control of the disease with these prolonged treatment intervals.

  4. Step 4

    Evaluation at week 68

    At week 68, the effectiveness of the treatment is evaluated. The primary measure of success is achieving an absolute PASI score of less than 3.

    This evaluation helps determine the long-term effectiveness of the treatment strategy.

Who can join the trial?

5 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have had plaque psoriasis for either 2 years or less, or more than 2 years. About 40% of participants should have had the disease for 2 years or less.
  • Must have moderate-to-severe plaque psoriasis, which means having a PASI score greater than 10 or more than 10% of the body affected, and a DLQI score greater than 10 at the start of the study. PASI score is a way to measure the severity of psoriasis, and DLQI score measures how much the skin condition affects daily life.
  • Must be a candidate for systemic treatment for psoriasis, which means treatment that affects the whole body, not just the skin.
  • If a woman, must either not be able to have children or, if able to have children, must use a highly effective method of birth control before the first dose of the study drug.
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Investigated drugs

Guselkumab is a medication used in this clinical trial to treat patients with moderate-to-severe plaque-type psoriasis. It works by targeting a specific protein in the immune system that contributes to the inflammation and overproduction of skin cells seen in psoriasis. The trial aims to evaluate if patients who respond exceptionally well to the treatment can maintain control of their disease with extended intervals between doses.

What is already known about the treatment

Guselkumab – Guselkumab is administered as an injection under the skin, typically every 16 weeks for patients who respond well to treatment. It is currently used in the medical field for treating moderate to severe plaque-type psoriasis, a chronic skin condition. The medication works by targeting a specific protein in the immune system called interleukin-23 (IL-23), which plays a role in inflammation and the overproduction of skin cells. Guselkumab is classified as a biologic therapy, specifically an interleukin inhibitor, and is well-documented in medical literature for its effectiveness in managing psoriasis symptoms.

Investigated diseases

Moderate to Severe Plaque Psoriasis – This is a chronic skin condition characterized by red, scaly patches that can appear on various parts of the body. The patches, known as plaques, are often itchy and can be painful. The disease occurs when skin cells multiply faster than normal, leading to a buildup of cells on the skin's surface. It typically progresses with periods of flare-ups and remissions. The severity can vary, with some individuals experiencing only mild symptoms, while others have more extensive and severe outbreaks. Environmental factors, stress, and certain medications can trigger or worsen the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508424-34-00Protocol codeCNTO1959PSO3012Estimated enrolment828 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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