Phase 3 VELA Study Findings Suggest Sonelokimab Effective for HS

MoonLake Immunotherapeutics has announced week 16 results from the phase 3 VELA-1 and VELA-2 trials of its registrational global program in patients with moderate-to-severe hidradenitis suppurativa (HS).1

These new data highlight the efficacy and safety of sonelokimab for moderate-to-severe HS. HS, a chronic, painful skin condition that typically begins in early adulthood, is known to leads to recurrent scarring, inflammatory lesions, and a profound dip in patients' quality of life.1

Sonelokimab was assessed during the phase 3 VELA-1 and VELA-2 studies. In June 2023, topline findings from the MIRA trial showed that the study met its primary endpoint at 12-weeks for Hidradenitis Suppurativa Clinical Response (HiSCR) 75. This endpoint is a higher measure of one's HS clinical response compared to the HiSCR50 measure. Both the VELA-1 and 2 studies were designed by investigators with HiSCR75 as the primary endpoint.

HiSCR75 was defined as ≥ 75% reduction in abscess and inflammatory nodule counts, without any rise in the presence of abscesses or draining tunnels from the point of baseline. Secondary endpoints included the proportions of patients reaching HiSCR50, a Dermatology Quality of Life Index (DLQI) improvement of > 4 points among study subjects with baseline scores above 4, and other outcomes.

These additional outcomes assessed included attaining at least a 55% International HS Severity Scoring System reduction (IHS4-55), a shift from baseline in participants' HS-specific Quality of Life (HiSQOL), and an improvement of 3 or more points in subjects' worst pain Numerical Rating Scale (NRS) among those with baseline pain scores ≥3.

There were 838 patients involved as study subjects in these 2 identically-designed trials, with a comparison being made between a 120 mg dose of sonelokimab and a placebo. The primary readout took place at the 16-week mark. Past this point, all subjects were given the 120 mg dose of sonelokimab up to the 48-week mark, with a final evaluation taking place at Week 52, followed by an open-label extension lasting up to 2 years.

The study's protocol mirrored that of the phase 2 MIRA study, which had determined the optimal dosing for patients with HS.2 Across this combined phase 3 program, the investigative team concluded that all primary and secondary endpoints achieved statistical significance (P <.001), including both lesion-related and patient-reported outcomes (PROs). In 1 notable conclusion, the team observed HiSCR75 responses as early as Week 4 and continued to improve through the 16-week mark.1

In a pre-specified interim analysis, investigators noted that participants initially randomized to placebo who shifted to sonelokimab at the 16-week mark were shown to have comparable responses to those treated from the point of baseline by Week 20. The investigators found at Week 16 that 34.8% of subjects from VELA-1 and 35.9% of those in VELA-2 who were given sonelokimab attained HiSCR75.

This was compared with 17.5% in the VELA-1 placebo arm and 25.6% in the VELA-2 placebo arm. Both of these studies, therefore, were found to have met their primary endpoint given these statistically significant improvements. VELA-1 and 2 investigators noted the consistent meeting of secondary endpoints. Sonelokimab demonstrated significant improvement in HiSQOL scores at the 16-week mark (P <.001) in both studies.

It was also noted that around 30% of subjects experienced at least a 3-point worst pain NRS score reduction (P ≤.002). Additionally, the investigators concluded that 60% of participants attained a DLQI improvement of 4 points at minimum, indicating roughly a 20 percentage-point advantage over those in the placebo arms (P ≤.001). They also identified significant HiSCR50 and IHS4-55 improvements.

Lastly, the research team found safety profile of sonelokimab showed consistency with prior research, adding that there was a lack of new safety concerns.1 They highlighted a lack of new signals particularly in areas of particular concern for IL-17A and F inhibitor therapies, including eczema, hepatic events, suicidal ideation and behavior, inflammatory bowel disease, or major adverse cardiovascular events (MACE).

References

1. MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab. Moon Lake Immunotherapeutics AG. September 28, 2025. https://www.globenewswire.com/news-release/2025/9/28/3157370/0/en/MoonLake-Immunotherapeutics-reports-on-week-16-results-of-the-VELA-Phase-3-hidradenitis-suppurativa-program-with-the-Nanobody-sonelokimab.html.

2. Phase 2 MIRA primary analysis trial results (12-week) for MoonLake’s Nanobody® sonelokimab in hidradenitis suppurativa to be presented at a late-breaking session at the European Academy of Dermatology and Venereology Congress. Moon Lake Immunotherapeutics AG. October 4, 2023. Accessed September 29, 2025. https://ir.moonlaketx.com/news-releases/news-release-details/phase-2-mira-primary-analysis-trial-results-12-week-moonlakes.