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A study to evaluate the long-term safety and effectiveness of sonelokimab in patients with psoriatic arthritis

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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 individuals living with psoriatic arthritis, a type of inflammatory arthritis that often affects both the skin and the joints. The purpose of this study is to evaluate the long-term safety and effectiveness of a medication called sonelokimab. This treatment is administered through a subcutaneous injection, which is a method of delivering medication into the fatty layer of tissue just beneath the skin.

During the course of this research, participants will receive regular doses of the study drug to observe how it affects the body over an extended period. Medical professionals will monitor various aspects of health, including vital signs such as blood pressure and heart rate, as well as electrocardiogram results, which are tests that record the electrical activity of the heart. Additionally, regular blood tests will be performed to check hematology and clinical chemistry, which are used to examine the components of the blood and the chemical balance in the body.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation

    Participation in this study involves receiving sonelokimab, which is the test medication being evaluated for the treatment of psoriatic arthritis, a type of arthritis that causes joint swelling and pain alongside skin issues.

    The medication is administered as a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

    The dose for this injection is 120 mg (milligrams).

  2. Step 2

    Safety monitoring

    Regular monitoring is conducted to track the safety and tolerability of the medication.

    This includes checking for adverse events, which are any unexpected or unwanted medical occurrences or side effects during treatment.

    vital signs, such as blood pressure and heart rate, are recorded, along with an electrocardiogram (ecg), which is a test that records the electrical activity of the heart.

    laboratory parameters, including hematology (tests checking blood cells) and clinical chemistry (tests checking chemicals in the blood), are reviewed to ensure organ function and overall health remain stable.

Who can join the trial?

11 criteria

  • The doctor believes that you are likely to benefit from joining this open-label extension (a phase of a study where both the doctor and the patient know which treatment is being used) study.
  • You must have already taken the final doses of the medication in the previous part of this study and completed your end-of-treatment (the final scheduled visit after finishing all doses) visit at the 52-week mark.
  • Your last dose of the study medication in the previous study must have been taken no more than 8 weeks before starting this new part of the study.
  • Women who are not pregnant or breastfeeding and are not at risk of becoming pregnant can participate.
  • Women who are able to become pregnant must agree to use very effective contraception (methods used to prevent pregnancy, such as birth control) during the study and for at least 8 weeks after the last dose.
  • Women who can become pregnant must have a negative pregnancy test one week before the first dose of this study.
  • Women who can become pregnant must not donate oocytes (female reproductive cells, also known as eggs) during the study or for 8 weeks after the last dose.
  • Men who cannot have children through surgery must agree to use a condom if they are sexually active with a partner who can become pregnant during the study and for 8 weeks after the last dose.
  • Men must agree not to donate sperm (male reproductive cells) during the study and for at least 8 weeks after the last dose.
  • The doctor must decide that you are able to follow the study rules, attend all scheduled visits, and take the medication correctly.
  • You must be able to understand the study details and provide informed consent (a signed document showing you understand the risks and benefits before agreeing to participate).

Who cannot join the trial?

5 criteria

  • You cannot join if you met any of the rules that required you to stop participating in the previous study, known as the parental study.
  • You cannot join if you are currently using or plan to use any prohibited treatments, which are specific medicines for psoriatic arthritis (an inflammatory condition affecting both the skin and joints) or other conditions that are not allowed in this study.
  • You cannot join if you plan to take part in another interventional study, which is a clinical trial where a person receives a specific treatment, drug, or medical device.
  • You cannot join if you were unblinded during the previous study, meaning you or your doctor learned whether you were receiving the actual medicine or a placebo (a substance with no active medicine).
  • You cannot join if you did not follow the rules of the previous study, which is referred to as noncompliance. This includes failing to follow the study plan or other major mistakes as decided by the doctor.
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Investigated drugs

Sonelokimab is an injection given under the skin that is being tested to see how well it works and how safe it is for people living with psoriatic arthritis over a long period of time.

What is already known about the treatment

Sonelokimab - This medication is given as an injection under the skin and is currently being studied in late-stage clinical trials to determine its long-term safety and effectiveness. It is used to treat psoriatic arthritis, a condition that causes joint pain and swelling. This drug works by targeting and blocking a specific protein in the body that triggers inflammation, thereby reducing the immune system's attack on the joints. It is classified as an anti-inflammatory biological therapy.

Investigated diseases

Psoriatic arthritis - This is a type of inflammatory arthritis that affects some people who have the skin condition known as psoriasis. It occurs when the immune system attacks the joints and the skin. The condition often causes swelling, pain, and stiffness in one or more joints. It can also affect the tendons, which are the tissues that connect muscles to bones. Over time, the inflammation may lead to changes in the shape of the joints or limited movement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522471-28-00Protocol codeM1095-PSA-303Estimated enrolment1 560 patientsSponsorMoonLake Immunotherapeutics AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).