MoonLake Immunotherapeutics
For the period ended Nov 4, 2026. Filed Nov 4, 2026.
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Nov 4, 2026 · Filed Nov 4, 2026
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EX-99.1 · About the S-OLARIS trial
About the S-OLARIS trial
The S-OLARIS trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60 mg administered subcutaneously in adult patients with active axSpA. The trial recruited 26 patients. The primary endpoint is the change from baseline (CfB) in 18F-NaF SUVmax signals at Week 12 in the sacroiliac joints and spine as detected by PET. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., Assessment of SpondyloArthritis International Society), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also features an innovative exploratory peripheral blood and tissue biomarker program. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in psoriatic arthritis, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513498-36-00 at https://euclinicaltrials.eu.
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