MoonLake screens first patient in Phase 2 study of sonelokimab

MoonLake Immunotherapeutics announced that the first subject has been screened in the United States, in a Phase 2 clinical study of the Nanobody sonelokimab in patients with active psoriatic arthritis. The global, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of different doses of sonelokimab compared to placebo, with adalimumab as an active reference arm, in approximately 200 patients with active PsA. The primary endpoint of the study is the American College of Rheumatology 50 response defined as the percentage of participants achieving greater than or equal to50% improvement in signs and symptoms of disease from baseline, compared to placebo. The study will also include a range of secondary endpoints reflecting the heterogeneous and multi-faceted nature of the disease, including the assessment of skin clearance, disability, enthesitis, pain, as well as other levels of ACR response Recruitment is on-going, with the first sites being initiated in Europe and in the United States. Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: "We are very pleased to have begun the ARGO study of the Nanobody sonelokimab in the treatment of psoriatic arthritis. In this study we have set high thresholds for outcomes across joint and skin domains of this multi-faceted disease, as we seek to evaluate the potential of sonelokimab’s IL-17A and IL-17F inhibition, small size and albumin-binding properties to significantly improve treatment outcomes for patients with inflammatory conditions."