A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

The primary objective is to evaluate the long-term safety and tolerability of subcutaneous sonelokimab in patients with psoriatic arthritis.

• The secondary objective is to describe the long-term efficacy of the investigated treatment.

This study involves 612 participants diagnosed with psoriatic arthritis. The study population consists of both male and female patients, including individuals categorized as vulnerable. Participants are within the age ranges designated by codes 3 and 4. Selection is based on the investigator's determination that individuals are expected to benefit from participation. Inclusion requires that subjects have completed the end-of-treatment visit of the parental study and received their final dose within a specific timeframe prior to the first dose of this open-label extension. Female participants must be of nonchildbearing potential or adhere to strict contraception requirements, including a negative pregnancy test. Male participants must utilize barrier methods and refrain from sperm donation during the study and for a designated period following the final administration of sonelokimab. All subjects must demonstrate the ability to adhere to the protocol and provide informed consent.

This Phase 3, multicenter, open-label extension study is designed to evaluate the long-term safety, tolerability, and efficacy of sonelokimab administered via subcutaneous injection in individuals with psoriatic arthritis. The study includes participants who have completed the end-of-treatment visit of the parental study and received their final dose of study treatment no more than 8 weeks prior to the first dose in this extension. The primary objectives are to monitor treatment-emergent adverse events, serious adverse events, and adverse events of special interest, as well as to assess changes in vital signs, electrocardiogram results, and laboratory parameters including hematology and clinical chemistry. Study participation involves a sequence of clinical visits to ensure adherence to the protocol and medication intake. Early termination may occur based on investigator judgment regarding a participant's ability to adhere to the visit schedule or protocol requirements.

The experimental treatment consists of sonelokimab, administered as an injection. The dosage is 120 mg delivered via subcutaneous route.

The clinical trial is designed to evaluate the long-term efficacy and safety of sonelokimab in participants diagnosed with psoriatic arthritis. Assessment of efficacy and safety involves the monitoring of treatment-emergent adverse events and serious adverse events. Additionally, the protocol includes the evaluation of adverse events of special interest and any events leading to study withdrawal.

Clinical parameters for assessment include vital signs, electrocardiogram results, and abnormal laboratory parameters, specifically involving hematology and clinical chemistry.