MoonLake Immunotherapeutics has commenced three new clinical trials to investigate the efficacy of sonelokimab, a Nanobody® targeting IL-17A and IL-17F, in adolescent hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP), and axial spondyloarthritis (axSpA). These trials build upon existing studies in adult HS and psoriatic arthritis (PsA), expanding the potential therapeutic applications of sonelokimab.
The newly initiated trials include the Phase 3 VELA-TEEN trial in adolescent HS, the Phase 2 LEDA trial in PPP, and the Phase 2 S-OLARIS trial in axSpA. These trials aim to address significant unmet needs in dermatology and rheumatology, where current treatment options are limited or inadequate.
VELA-TEEN: Adolescent Hidradenitis Suppurativa
The Phase 3 VELA-TEEN trial is an open-label, single-arm study designed to assess the pharmacokinetics, safety, and tolerability of sonelokimab in 30-40 adolescents aged 12-17 with moderate-to-severe HS. Participants will receive 120mg of sonelokimab subcutaneously every two weeks until week six, followed by every four weeks from week eight onwards. The primary endpoint focuses on safety and tolerability over 24 weeks. Secondary endpoints include the proportion of patients achieving HiSCR75, a higher clinical response measure, as well as changes in the International Hidradenitis Suppurativa Severity Score System (IHS4) and improvements in quality of life as measured by the Children’s Dermatology Life Quality Index (CDLQI).
Amy S. Paller, MD, Principal Investigator of the trial, emphasized the unmet medical needs of adolescents with HS, stating, "Adolescents with HS face substantial unmet medical needs and are a critically underserved patient population. The VELA-TEEN trial marks a significant advancement in HS treatment. By prioritizing early intervention, we hope to alter the disease course, reduce tissue destruction, and prevent permanent damage."
Topline data for the primary and secondary endpoints, including HiSCR75, are expected in 2026. MoonLake plans to combine data from the VELA-TEEN trial with data from the Phase 3 VELA program in adults with moderate-to-severe HS to support a single Biologics License Application (BLA).
LEDA: Palmoplantar Pustulosis
The Phase 2 LEDA trial will evaluate the efficacy and safety of sonelokimab in approximately 30 adult patients with PPP. Participants will receive 120mg of sonelokimab subcutaneously. The primary endpoint is the percent change from baseline in the Palmoplantar Psoriasis Area and Severity Index (ppPASI). Secondary endpoints include the proportion of patients achieving ppPASI75, indicating at least a 75% improvement in the ppPASI. The trial also incorporates a biomarker-controlled translational research program.
Mark Lebwohl, MD, commented on the need for advanced therapies for PPP, stating, "Palmoplantar pustulosis is a chronic, recurrent inflammatory condition affecting the palms and soles, marked by aggressive pustule eruptions, skin destruction, and severe pain... It is exciting to see studies with innovative technologies like nanobodies to address this urgent medical need."
Topline data for the primary endpoint are expected in 2025.
S-OLARIS: Axial Spondyloarthritis
The Phase 2 S-OLARIS trial is an open-label study investigating sonelokimab in approximately 25 patients with active axSpA. Participants will receive 60mg of sonelokimab subcutaneously. The primary endpoint is the change from baseline at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine, assessed using PET in combination with MRI imaging. The trial will also evaluate established clinical disease activity outcomes, scores related to physical function, and patient-reported outcomes. An exploratory peripheral blood and tissue biomarker program is also included.
Professor Xenofon Baraliakos commented on the innovative design of the trial, stating, "Integrating cutting-edge imaging techniques like MRI-PET with clinical outcomes, as being used in the S-OLARIS trial, offers a promising path forward... Our goal must be to develop more effective treatments that can improve long-term outcomes, reduce disease progression, and enhance the quality of life for all axSpA patients."
Topline data for the primary endpoint are expected in early 2026.
These trials represent a significant expansion of MoonLake's clinical program for sonelokimab, which now includes ten independent trials across a range of dermatology and rheumatology indications. Data readouts are anticipated in 2025 and 2026, potentially paving the way for new treatment options for these debilitating inflammatory diseases.
