MoonLake's sonelokimab HS trials sit completed with 52-week data still unreleased
VELA-1 and VELA-2 finished in June 2026, but the 52-week HiSCR75 readout MoonLake guided to Q2 2026 has not been disclosed as that window closed.
Executive Summary
- MoonLake ran two Phase 3 trials of sonelokimab against placebo in adults with moderate to severe hidradenitis suppurativa and told investors to expect 52-week data in the second quarter of 2026.
- Both trials have since moved to Completed status on the registry, meaning the underlying data exist, but the 52-week result MoonLake guided to has not surfaced publicly even as that quarter has closed.
- The company has already used earlier interim looks at this same long-term data to frame sonelokimab's competitive position ahead of a Type B meeting with the FDA and a planned BLA filing, so the mature 52-week numbers matter for what regulators and investors ultimately see.
- Sonelokimab enters an IL-17A field that already includes Novartis's secukinumab and UCB's bimekizumab in active hidradenitis suppurativa trials, and it differs from both by targeting IL-17F as well as IL-17A through a nanobody format rather than a conventional monoclonal antibody.
The trial and its endpoint
NCT06411899, one of two identically designed VELA trials, tested subcutaneous sonelokimab against placebo in 422 adults with moderate to severe hidradenitis suppurativa across ten countries. The primary endpoint was Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), a composite measure of at least a 75% reduction in inflammatory lesions without new draining tunnels or abscesses. The trial started in May 2024, reached its primary completion date on September 2, 2025, and moved to Completed status on June 8, 2026. NCT06411899A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaNCT06411899
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The guidance MoonLake gave
MoonLake told investors in a November 5, 2025 earnings release that it expected 52-week data from VELA-1 and VELA-2, describing an interim analysis at that time as showing continuous clinical improvement and competitive benefit for sonelokimab beyond the Week 16 primary endpoint. The company repeated that Q2 2026 guidance in subsequent updates through May 2026, holding the same April 1 to June 30 window across five separate disclosures. That window has now closed without the mature 52-week result reaching the public record. MoonLakeMoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data ...Nov 5, 2025
What the interim data showed
An earlier interim readout at Week 40 reported that 62% of sonelokimab-treated patients achieved HiSCR75, with up to 32% reaching HiSCR100, and up to 25% reaching inflammatory remission defined as complete resolution of abscesses, nodules and draining tunnels. Those figures set the bar the 52-week analysis will either extend or fail to hold: MoonLake's own framing treats durability past Week 16, not just the initial response, as the differentiating data point for its BLA package. MoonLakeMoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data ...Nov 5, 2025
Operational picture
Enrollment moved from 400 to 422 patients in May 2025, a 5.5% increase that sits inside the routine range for a registrational trial and carries no operational-risk signal. The trial's amendment history shows one endpoint-related counter change and no primary-completion-date churn, and the registry's own stability read labels it Stable. The primary completion date landed three months after the original target, a routine slip for a multi-country Phase 3 program rather than a pattern that threatens the readout. NCT06411899A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaNCT06411899
The competitive field
Sonelokimab is a bispecific nanobody targeting both IL-17A and IL-17F, distinct from Novartis's secukinumab, an IL-17A monoclonal antibody now in a Phase 4 hidradenitis suppurativa trial, and from UCB Pharma's bimekizumab, an IL-17A/IL-17F dual inhibitor already running Phase 3 hidradenitis suppurativa trials. The IL-17A-in-hidradenitis-suppurativa pairing has produced 6 successes among 8 resolved Phase 3 readouts historically, with a 14% Phase 3 failure rate across two terminated programs from two sponsors. Against that backdrop, a 52-week result that sustains or improves on the Week 40 interim figures would be the outcome that matters for whether sonelokimab's dual-target profile translates into a durability edge over single-target IL-17A antagonists already active in the same indication.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.