Sonelokimab delivers deep skin clearance and improves the quality of life in HS patients

The interleukin-17A/F (IL-17A/F)-targeting nanobody sonelokimab demonstrated high efficacy in patients with moderate-to-severe hidradenitis suppurativa (HS) over 40 weeks. Approximately 30% of patients achieved complete clearance across studies, accompanied by marked improvements in patient-reported disease burden.

Hidradenitis suppurativa (HS) remains one of the most therapeutically challenging conditions in dermatology, with a clear need for novel treatment options. Sonelokimab is a tri-specific nanobody that binds IL-17A and IL-17F and incorporates an anti-albumin moiety to prolong systemic exposure. As Prof. Alexa Kimball (Beth Israel Deaconess Medical Center, MA, USA) explained, the small molecular size of nanobodies may confer enhanced tissue penetration, favourable pharmacokinetics, and potentially improved safety compared with conventional monoclonal antibodies [1]. These properties previously translated into positive phase 2 results in HS, as well as in psoriasis and psoriatic arthritis [2].

The replicate phase 3 VELA-1 (NCT06411899) and VELA-2 (NCT06411379) trials randomised 838 adults with moderate-to-severe HS in a 2:1 ratio to sonelokimab or placebo. The primary endpoint, Hidradenitis Suppurativa Clinical Response by at least 75% (HiSCR75) at week 16, was achieved by approximately one-third of sonelokimab-treated patients, compared with 18%–25% in the placebo group. The current interim analysis extended follow-up to week 40 and included monthly maintenance dosing.

At week 40, 62% of patients achieved HiSCR75 across both trials, while 74%–79% reached HiSCR50. Deeper responses were also observed, with HiSCR90 achieved by 36%–40% of patients and complete clearance (HiSCR100) by approximately 30% of the pooled population. Lesion-specific analyses demonstrated reductions of 71–75% in inflammatory nodules, 72–79% in abscesses, and 60–69% in draining tunnels.

Patient-reported outcomes mirrored these clinical improvements. At baseline, 59% of patients were classified as having “very severe” disease according to the Hidradenitis Suppurativa Quality of Life (HiSQOL) measure; by week 40, 63% had improved to “mild or none.”

Tolerability remained favourable. Although the full 52-week safety data are pending, week 16 results showed serious treatment-emergent adverse events in 2.5% of sonelokimab-treated patients. The most common adverse events were nasopharyngitis (8.6%) and oral candidiasis (7.3%). Follow-up to week 52 is ongoing, alongside a long-term extension of the VELA programme and a separate trial in adolescents (12–17 years). Notably, up to 43% of patients experienced a marked reduction in pain.

With monthly dosing, biologic-comparable HiSCR100 rates of approximately 30%, and consistent improvements in quality of life, sonelokimab represents a promising option for the long-term management of moderate-to-severe HS.

Kimball A. Sonelokimab in moderate-to-severe hidradenitis suppurativa: 40-week results from the phase III VELA-1 and VELA-2 trials. S034: Late-breaking Research Session 2. AAD 2026, 27–31 March, Denver, CO, USA.
Sayed CJ, et al. J Am Acad Dermatol 2025;93(3) Suppl. AB2221.