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Study of sonelokimab and risankizumab in adults with psoriatic arthritis who did not respond well to previous TNF inhibitor treatment

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What is this trial about?

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

This study focuses on psoriatic arthritis, a condition that causes joint pain and swelling along with skin symptoms. The research compares two medications: sonelokimab and risankizumab, which are given by injection under the skin. Some participants will receive placebo instead of active medication. The purpose is to determine how well sonelokimab works in treating people with psoriatic arthritis who have not responded well to previous treatments.

During the study, participants will receive either sonelokimab at different doses, risankizumab, or placebo through subcutaneous injection. The medications work by targeting specific proteins in the body that cause inflammation. The main focus will be on checking if sonelokimab helps reduce joint symptoms after 16 weeks of treatment.

The study will monitor how the medications affect both joint pain and skin symptoms associated with psoriatic arthritis. Participants will have regular check-ups to assess their response to treatment and to monitor their overall health. The medications being tested are designed to help reduce inflammation and improve symptoms in people whose condition has not improved enough with other treatments called TNF-alpha inhibitors.

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 assessment

    Your eligibility for the study will be evaluated based on specific criteria, including being at least 18 years old and having psoriatic arthritis for 6 months or longer

    You must have moderate to severe active disease with 3 or more tender and swollen joints

    You need to have active plaque psoriasis or nail changes related to psoriasis

    Previous treatment with 1 or 2 TNF inhibitors that didn't work well enough or caused side effects is required

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of four treatment groups

    You may receive either sonelokimab 60 mg, sonelokimab 120 mg, risankizumab, or placebo

    All medications will be given by subcutaneous injection (under the skin)

  3. Step 3

    Treatment period

    The main evaluation period lasts for 16 weeks

    During this time, you will receive the assigned treatment according to a specified schedule

    Regular assessments will track changes in your joint symptoms and psoriasis

  4. Step 4

    Safety monitoring

    Throughout the study, your health will be monitored through regular checks of:

    Blood pressure and heart rate

    Blood tests

    Body weight

    Heart activity (ECG)

    Any side effects that may occur

  5. Step 5

    Study completion

    The study is expected to run until December 2026

    Your participation will help evaluate how well the medications work for treating psoriatic arthritis

    The main goal is to see if 50% improvement in arthritis symptoms is achieved after 16 weeks of treatment

Who can join the trial?

11 criteria

  • Must be at least 18 years old at the time of signing consent
  • Must have confirmed psoriatic arthritis diagnosed for at least 6 months before screening
  • Must have moderate to severe active disease with at least 3 tender joints and 3 swollen joints
  • Must have active plaque psoriasis with at least one psoriatic plaque of 2 cm or larger, or nail changes from psoriasis, or documented history of plaque psoriasis
  • Must test negative for rheumatoid factor (a blood protein) and anti-cyclic citrullinated peptide (antibodies linked to rheumatoid arthritis) during screening
  • Must have been taking stable doses of NSAIDs (anti-inflammatory medications) for at least 4 weeks with inadequate symptom control, or have documented intolerance to NSAIDs
  • Must have previously received 1 or 2 TNFα inhibitors (specific type of biological medication) for at least 3 months with inadequate response, or stopped due to side effects
  • Women must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for 21 weeks after the last treatment
  • Men must agree to use condoms when sexually active with partners who could become pregnant during the study and for 8 weeks after the last treatment, unless surgically sterile
  • Must be able to follow the study schedule and medication requirements reliably
  • Must be able to understand and sign informed consent documents

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years old
  • Previous treatment with sonelokimab (the study medication)
  • Active or chronic infections, including tuberculosis or hepatitis B or C
  • History of cancer within the past 5 years
  • Pregnancy or breastfeeding
  • Significant heart, liver, or kidney disease
  • Current treatment with other biological medications (medications that target the immune system)
  • Major surgery planned during the study period
  • Participation in another clinical trial within the past 30 days
  • Uncontrolled high blood pressure
  • Active skin conditions other than psoriasis that could interfere with evaluation
  • History of substance abuse within the past 6 months
  • Mental health conditions that could affect study participation
  • Known allergies to study medication components
  • Use of live vaccines within 12 weeks before starting the study
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Investigated drugs

  • Sonelokimab

    is a medication being studied for treating psoriatic arthritis. It is given as an injection under the skin (subcutaneously) to help reduce joint inflammation and symptoms in patients who haven't responded well to previous treatments. This medication works by targeting specific proteins in the body that cause inflammation.

  • Risankizumab

    is used as an active reference medication in this trial. It is also given as an injection under the skin and is already approved for treating psoriatic arthritis. It works by blocking a specific protein in the body that causes inflammation, helping to reduce joint pain and swelling.

What is already known about the treatment

  • Sonelokimab

    A novel injectable medication administered subcutaneously (under the skin) that is currently being investigated in Phase 3 clinical trials for the treatment of psoriatic arthritis, particularly in patients who have not responded well to or cannot tolerate TNF-α inhibitors. This biological medication belongs to the class of targeted immunotherapy drugs and works by modulating specific components of the immune system involved in inflammation. The drug is being studied in two different dosage strengths (60 mg and 120 mg) to evaluate its effectiveness in reducing joint symptoms and inflammation associated with psoriatic arthritis, with measurements based on standardized ACR50 response criteria.

  • Risankizumab

    An approved biological medication administered via subcutaneous injection that serves as an active reference comparator in clinical trials for psoriatic arthritis treatments. It belongs to the class of interleukin-23 (IL-23) inhibitors and works by blocking a specific protein that causes inflammation in the body. This medication is already established in medical practice for treating various inflammatory conditions and is used as a benchmark to evaluate the effectiveness of new treatments in development.

Investigated diseases

Psoriatic Arthritis - A chronic inflammatory condition that affects joints and typically occurs in people with psoriasis. The disease causes joints to become painful, swollen, and stiff, most commonly affecting fingers, toes, wrists, knees, ankles, or lower back. It can develop slowly or appear suddenly, and symptoms may vary from mild to severe. The condition often causes joints to feel warm to the touch and can lead to reduced range of motion. Some people may experience periods where symptoms improve or worsen over time.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516219-25-00Protocol codeM1095-PSA-302Estimated enrolment600 patientsSponsorMoonLake Immunotherapeutics AG

sourced from the EU Clinical Trials Register and site verification

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