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Study of sonelokimab injection in adults with active psoriatic arthritis who have not received biological DMARDs treatment before

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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 inflammation in people who have psoriasis. The study will test a new medication called sonelokimab, which is given as a subcutaneous injection under the skin. This medicine works by blocking specific proteins in the body that cause inflammation.

The purpose of this research is to determine how well sonelokimab works compared to placebo in treating people with active psoriatic arthritis who have not previously used biological medications. The study will compare two different ways of giving sonelokimab against placebo treatment.

Participants will receive either sonelokimab injections or placebo for 16 weeks. The medication dose will be 60 milligrams, given every four weeks. Throughout the study, doctors will monitor the participants' symptoms, particularly focusing on how their joint pain and inflammation respond to the treatment. The study will also track any changes in participants' ability to perform daily activities and their overall well-being.

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 visit and assessment

    You will undergo initial assessment to confirm your eligibility for the study if you have psoriatic arthritis for at least 6 months

    Your doctor will verify that you have at least 3 tender joints and 3 swollen joints

    You must have at least one psoriatic plaque of 2 cm or more, or nail changes consistent with psoriasis

  2. Step 2

    Assignment to treatment group

    You will be randomly assigned to one of three groups:

    Group 1: Sonelokimab 60 mg with induction regimen

    Group 2: Sonelokimab 60 mg without induction regimen

    Group 3: Placebo (inactive substance)

  3. Step 3

    Treatment administration

    You will receive subcutaneous injections (under the skin)

    The treatment will be given every 4 weeks

    The study will continue for at least 16 weeks to evaluate the primary results

  4. Step 4

    Monitoring and assessment

    Regular evaluations will check your joint pain and swelling

    Your psoriasis symptoms will be monitored

    Blood tests and other safety assessments will be performed

    Your ability to perform daily activities will be evaluated

    X-rays will be taken to check joint damage

  5. Step 5

    Final assessment

    At week 16, your response to treatment will be evaluated

    The main measurement will be a 50% improvement in arthritis symptoms (ACR50)

    Your psoriasis improvement will be assessed if you had skin involvement at the start

    Overall health status and quality of life measurements will be taken

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must have confirmed psoriatic arthritis with symptoms present for at least 6 months
  • 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 patch of 2 cm or larger, or nail changes from psoriasis, or documented history of plaque psoriasis
  • Must test negative for rheumatoid factor and anti-cyclic citrullinated peptide (proteins found in blood that can indicate certain types of arthritis)
  • Must have been taking stable doses of anti-inflammatory medications (NSAIDs) for at least 4 weeks with inadequate symptom control, or have documented inability to take these medications
  • Must have tried at least one conventional disease-modifying medication (such as methotrexate, sulfasalazine, or leflunomide) for at least 12 weeks with inadequate response, or have documented inability to take these medications
  • Must have at least one bone erosion on hand and feet X-rays OR elevated levels of C-reactive protein (a marker of inflammation in blood)
  • Women who can become pregnant must use effective birth control during the study and for 8 weeks after the last treatment
  • Men must use condoms when sexually active with partners who can become pregnant during the study and for 8 weeks after the last treatment, unless surgically sterile
  • Must be able to follow the study protocol and schedule
  • Must be able to understand and sign informed consent documents

Who cannot join the trial?

15 criteria

  • Age below 18 or above 75 years old
  • Previous treatment with sonelokimab (the study medication)
  • Known allergic reactions to biological medications
  • Active or chronic infections, including tuberculosis and hepatitis B or C
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Pregnant or breastfeeding women
  • Significant heart problems or uncontrolled high blood pressure
  • Severe kidney or liver disease
  • Other inflammatory arthritis conditions besides psoriatic arthritis
  • Major surgery planned during the study period
  • Participation in another clinical trial within 30 days before this study
  • Active substance abuse or mental health conditions that could interfere with study participation
  • Use of prohibited medications, including certain immunosuppressive drugs (medications that weaken the immune system)
  • Unstable psoriatic arthritis requiring immediate change in treatment
  • Live vaccines received within 12 weeks before starting the study
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Investigated drugs

Sonelokimab is a new biological medication that is being studied for treating psoriatic arthritis. It is given as an injection under the skin (subcutaneously) to patients who have never received biological disease-modifying antirheumatic drugs (DMARDs) before. This medication works by targeting specific components of the immune system that are involved in causing joint inflammation and skin symptoms in psoriatic arthritis. A Placebo is used in this study as a comparison treatment. It is an inactive substance that looks identical to the real medication but contains no active ingredients. This helps researchers determine how effective the actual medication is by comparing results between patients who receive the real medication and those who receive the placebo.

What is already known about the treatment

Sonelokimab - A novel biologic medication administered through subcutaneous injection that is currently being investigated in Phase 3 clinical trials for the treatment of psoriatic arthritis in patients who haven't previously received biological disease-modifying antirheumatic drugs (DMARDs). The drug belongs to the class of biological response modifiers and works by targeting specific inflammatory pathways involved in psoriatic arthritis. This investigational treatment is being studied with different dosing regimens, including a 60 mg dose given every 4 weeks, with and without an initial induction period, to evaluate its efficacy and safety in improving joint symptoms and overall disease activity in patients with active psoriatic arthritis.

Investigated diseases

Psoriatic arthritis - A chronic inflammatory joint condition that typically develops in people who have psoriasis. The condition causes joint pain, stiffness, and swelling that can affect any part of the body, particularly the fingers, toes, wrists, ankles, and lower back. It often results in joints becoming tender and swollen, with some people experiencing reduced range of motion. The condition can vary in severity, with some people having mild symptoms while others experience more persistent joint problems. The inflammation can also affect surrounding tendons and ligaments, causing additional discomfort and reduced mobility.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516213-20-00Protocol codeM1095-PSA-301Estimated enrolment1 162 patientsSponsorMoonLake Immunotherapeutics AG

sourced from the EU Clinical Trials Register and site verification

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