VELA: Phase 3 Data Suggest Sonelokimab Effective for HS, With Alexa Kimball, MD, MPH
New late-breaking data presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting suggest sonelokimab may deliver sustained clinical and quality-of-life improvements for adults with moderate-to-severe hidradenitis suppurativa (HS).1,2
These findings resulted from the phase 3 VELA-1 and VELA-2 trials. In an on-site interview, VELA trial investigator Alexa Kimball, MD, MPH, of Harvard Medical School, discussed the broader implications of these findings, including how higher response thresholds like Hidradenitis Suppurativa Clinical Response (HiSCR) 75 may help redefine treatment goals and expectations in HS management.
“What was great to see in the data…is that the efficacy seems to be quite have a very high slope at the beginning of treatment and then continues to improve over time through Week 40 with hidradenitis suppurativa,” Kimball expressed.
838 individuals were assessed in the global VELA program, with investigators utilizing the more stringent HiSCR 75 as their primary endpoint, reflecting at least a 75% reduction in patients’ abscess and inflammatory nodule count without worsening of abscesses or draining tunnels. Kimball et al found, by Week 40, approximately 62% of those on sonelokimab attained HiSCR75, with up to 32% achieving complete lesion clearance (HiSCR100).
These findings were described as consistent across both analyses, suggesting a high level of durable disease control with the drug’s use. Additional measures of HS severity and symptom burden also demonstrated meaningful improvement, Kimball and colleagues found. Up to 77% of those evaluated achieved at least a 55% reduction in International HS Severity Scoring System (IHS4-55), and approximately a quarter reached inflammatory remission. Such outcomes point to substantial reductions in inflammatory activity.
Notably, Kimball and coauthors’ clinical gains were accompanied by notable improvements in the patient-reported outcomes seen in the VELA program. Quality-of-life scores, as determined by the HS Quality of Life (HiSQOL) instrument, were found to have risen significantly through the 40-week mark, with many individuals on the drug transitioning from severe baseline impairment to mild or no impact.
Additionally, the investigators noted improvements across key functional and emotional domains, including mobility, pain, and mood. Kimball and colleagues also found up to 43% of subjects reported clinically meaningful reductions in their level of pain, and roughly two-thirds achieved meaningful improvements in Dermatology Life Quality Index (DLQI) scores.
The safety profile of this medication was shown to be consistent with earlier findings, with Kimball et al finding no new safety signals over 40 weeks of treatment.
Kimball’s institution received grants from Abbvie, Admirx, Anapyts Bio, Aristea, Bristol Myers Squibb, Chemocentryx, Eli Lilly, Incyte, Janssen, MoonLake, Novartis, Pfizer, Prometheus, UCB; Sonoma Bio. Kimball received consulting fees from Abbvie, Alumis, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Moonlake Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, UCB; Target RWE, Ventyx; and serves on the board of directors of Almirall.
References
MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting. MoonLake. March 28, 2026. Accessed March 30, 2026. https://www.globenewswire.com/news-release/2026/03/28/3264203/0/en/MoonLake-announces-Week-40-Results-from-its-Phase-3-Clinical-Trials-of-Sonelokimab-in-Hidradenitis-Suppurativa-at-the-2026-AAD-Annual-Meeting.html.
Kimball A. Sonelokimab in moderate-to-severe HS: long-term results through week 40 of two phase 3 trials. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.