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.
1Initial 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
2Treatment 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)
3Treatment 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
4Safety 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
5Study 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 Study?
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 Study?
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
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.
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.
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