Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Phase 2 Completed 207 enrolled MoonLake Immunotherapeutics AG

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.

Timeline

Start: 2022-12-13
Primary completion: 2023-09-05
Completion: 2024-01-15

Outcome

Met primary endpoint

paper The primary endpoint of American College of Rheumatology (ACR) 50 at week 12 was met for SLK 60-mg and 120-mg WI PMID 41053449 ↗

release “The ARGO trial (M1095-PSA-201), which enrolled 207 patients, met its primary endpoint” moonlaketx.com ↗

Publications

Results McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF. Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. Nat Med. 2025 Dec;31(12):4160-4171. doi: 10.1038/s41591-025-03971-6. Epub 2025 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	—	—
Subject	M1095	Protein / enzyme biologic	60 mg	Subcutaneous
Subject	M1095	Protein / enzyme biologic	120 mg	Subcutaneous