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A Study of Guselkumab and Ciclosporin in Patients with Early Psoriatic Arthritis Transitioning from Skin to Joint Disease

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 study involves people who have skin psoriasis and are experiencing joint pain that may be an early sign of psoriatic arthritis, a condition where the immune system causes inflammation in the joints along with skin symptoms. The study will test whether treatment with guselkumab, also known by its code name CNTO 1959, can help improve these early joint symptoms. Guselkumab is given as an injection under the skin. Some participants will receive ciclosporin, a medicine that suppresses the immune system and is taken by mouth as a capsule. The study aims to find out if treatment can lead to improvement in both symptoms and inflammation seen on ultrasound scans by week 24, specifically looking at whether joint pain goes away and whether inflammation in the joints and tendons decreases.

During the study, participants will be randomly assigned to receive one of the treatments and will be followed for up to 52 weeks. The main focus at week 24 is to see how many people no longer have joint pain and show improvement in inflammation of the joints and tendons as measured by ultrasound imaging. Ultrasound is a type of scan that uses sound waves to create pictures of the inside of the body, allowing doctors to see inflammation in joints, tendons, and the areas where tendons attach to bone called entheses. The study will also track whether people develop full psoriatic arthritis by week 52, how well their skin psoriasis improves, and how their daily activities and quality of life are affected.

Throughout the study, doctors will use various measures to assess joint pain, skin symptoms, and inflammation. X-rays will be used to check for any changes in the joints over time. Participants will complete questionnaires about their pain, physical function, and how psoriasis and joint symptoms affect their daily life. The study will compare the effects of the different treatments to determine which approach is most effective in preventing or delaying the progression from early joint symptoms to full psoriatic arthritis while also treating the skin condition.

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

    Initial treatment phase

    Upon joining the trial, you will begin receiving one of the assigned treatments. The trial compares two different approaches to managing your condition.

    You may receive either guselkumab (a biological medication given as an injection under the skin) or ciclosporin (a medication taken by mouth). The specific medication, dose, and frequency will be determined by the trial protocol.

    The guselkumab injection contains 100 milligrams per milliliter and is administered under the skin using a pre-filled syringe.

    This initial treatment phase will continue as you progress through the trial assessments.

  2. Step 2

    Week 24 assessment

    At week 24, you will undergo a comprehensive evaluation to measure the trial's main outcomes.

    Your joint pain will be assessed using a pain scale (ranging from 0 to 10) and a count of tender joints. The goal is to determine if your joint pain has resolved, defined as a pain score of 1 or less out of 10 and having 1 or fewer tender joints.

    You will also have an ultrasound examination to evaluate inflammation in your joints, tendons, and the areas where tendons attach to bone. This examination helps measure changes in inflammation compared to when you started the trial.

    The ultrasound will examine 42 different areas including the joints in your hands, wrists, knees, and feet, as well as specific tendons and attachment points.

    Your skin condition will be evaluated to determine the extent of improvement in your psoriasis, measured using a scoring system called PASI.

    You will complete questionnaires about your daily function, quality of life, and how the condition affects you.

  3. Step 3

    Continuation of treatment until week 52

    After the week 24 assessment, you will continue with the assigned treatment.

    During this period, ongoing monitoring will occur to track your condition and any changes in symptoms.

  4. Step 4

    Week 52 final assessment

    At week 52, you will undergo a final comprehensive evaluation.

    The ultrasound examination will be repeated to measure changes in inflammation in your joints and tendons compared to earlier assessments.

    Your joint pain will be assessed again using the same pain scale and tender joint count to determine if pain resolution has been maintained or achieved.

    Your skin condition will be evaluated again to measure the degree of psoriasis improvement.

    You will have X-rays taken of your joints to assess any structural changes, including joint erosions or narrowing of joint spaces. These will be compared to X-rays taken at the beginning of the trial.

    You will complete the same questionnaires about daily function, quality of life, and disease impact.

    The medical team will assess whether you have developed active psoriatic arthritis during the trial period.

Who can join the trial?

9 criteria

  • You must be an adult who is 18 years of age or older.
  • You must be able to understand all the requirements of the study and be willing to follow them throughout the entire research period.
  • You must voluntarily agree to participate in the study and sign a document called an informed consent, which is a form that explains the study and confirms you agree to take part.
  • You must be willing and able to follow all procedures that are required during this study.
  • You must have skin psoriasis, which is a skin condition that causes red, scaly patches. This can be either moderate to severe, or mild if it affects sensitive areas such as your face, palms, soles, nails, or genital area. A doctor who specializes in skin conditions and has experience with psoriasis must have diagnosed you.
  • You must not have any signs of active arthritis, which means joint inflammation, dactylitis, which means swelling of entire fingers or toes, enthesitis, which means inflammation where tendons or ligaments attach to bones, or inflammatory back pain at the time you join the study.
  • You must not have received any systemic treatment for psoriasis in the last 6 months. Systemic treatment means medications that work throughout your whole body, including pills or injections that affect your immune system.
  • You must have peripheral arthralgia, which means pain in the joints of your arms or legs that doctors suspect could be related to early joint problems associated with psoriasis.
  • You must have at least 2 out of 4 specific findings on an ultrasound, which is an imaging test that uses sound waves to look inside your body. These findings include signs of inflammation or damage in your joints, tendons, or the places where tendons attach to bones that suggest early joint involvement related to psoriasis.

Who cannot join the trial?

4 criteria

  • The specific exclusion criteria (reasons why you cannot participate in this study) have not been provided in the available study information.
  • If you are interested in participating, the study team will need to review your complete medical history to determine if you meet all requirements for participation.
  • Generally, clinical trials have specific rules about who can and cannot join to ensure the safety of participants and the accuracy of results.
  • The study doctor will discuss with you whether you are suitable for this research study during your initial evaluation.
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Investigated drugs

Guselkumab is a medication that works with your immune system to reduce inflammation in your body. In this trial, it is being tested to see if it can help prevent joint problems in people with psoriasis who are starting to have early signs of joint disease but don't yet have full psoriatic arthritis. The medicine is given to reduce pain and swelling in the joints before the condition gets worse.

What is already known about the treatment

Guselkumab – Guselkumab is a medication given as an injection under the skin that works by blocking a specific protein in the body called interleukin-23, which plays a key role in causing inflammation in conditions like psoriatic arthritis and psoriasis. This medication is currently approved and widely used in medical practice for treating moderate to severe plaque psoriasis and active psoriatic arthritis in adults. In this clinical trial, researchers are studying whether Guselkumab can help prevent the progression from skin disease to joint disease in patients who have early signs of psoriatic arthritis but haven't yet developed full symptoms, by reducing inflammation in the joints and surrounding tissues. The drug belongs to a class of medications called interleukin inhibitors or biologic disease-modifying drugs, which target specific parts of the immune system to reduce harmful inflammation.

Investigated diseases

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and occurs in people who have psoriasis, a skin disease. The disease causes joint pain, stiffness, and swelling that can affect any part of the body, including fingertips and spine. In subclinical psoriatic arthritis, patients experience joint pain and tenderness but do not yet meet the full criteria for diagnosis of the condition. The inflammation affects not only the joints but also the entheses, which are the sites where tendons and ligaments attach to bone. Over time, the condition can progress from subclinical arthralgia to fully developed psoriatic arthritis with more pronounced joint involvement. The disease can cause progressive joint damage if the inflammatory process continues unchecked.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523551-54-00Protocol codeARRESTEstimated enrolment100 patientsSponsorAzienda Sanitaria Universitaria Friuli Centrale

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