Sonelokimab, a novel IL-17A- and IL-17F-inhibiting nanobody for the treatment of moderate-to-severe hidradenitis suppurativa: a global, randomized, double-blind, placebo-controlled phase 2 clinical trial (MIRA)
In brief
Sonelokimab brings HS response rates to 35% to 43%, versus 15% with placebo
In this randomized phase 2 trial, 35% of patients on the 240 mg dose and 43% on 120 mg achieved the trial's HS Clinical Response 75 measure at week 12, compared with 15% on placebo. Responses rose or held through week 24, with no new safety signals; larger, longer phase 3 trials will test durability and safety.
- Journal
- Journal of the American Academy of Dermatology (Q1)
- Published
- 1 October 2026
- Study design
- Phase 2 randomized trial (exploratory)
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Alexa B Kimball, Falk G Bechara, Martina L Porter, Errol Prens, Gregor B E Jemec, James G Krueger, et al.
- PMID
- 42822776
- DOI
- 10.1016/j.jaad.2026.09.099
Why clinicians should know about it
- Picked for Dermatology (paper of the day, 3 October 2026): Phase 2 RCT of sonelokimab in hidradenitis suppurativa
Abstract
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic disabling and debilitating inflammatory disease with limited therapeutic options. OBJECTIVE: To present the primary results of the phase 2 MIRA trial, which evaluated the efficacy and safety of the IL-17A- and IL-17F-inhibiting nanobody sonelokimab in adults with moderate-to-severe HS. METHODS: MIRA was a 24-week global, randomized, prospective, parallel-group, double-blind, placebo-controlled trial. Eligible patients were randomized (2:2:2:1) to receive subcutaneous sonelokimab 120 mg, sonelokimab 240 mg, placebo, or adalimumab (active reference arm). The primary endpoint was the proportion of patients achieving HS Clinical Response 75 (HiSCR75) versus placebo at week 12 using non-responder imputation in an intention-to-treat population. RESULTS: Two hundred thirty-four patients were randomized (sonelokimab 120 mg, n=67; sonelokimab 240 mg, n=66; placebo, n=68; adalimumab active reference arm, n=33). The primary endpoint of HiSCR75 was met for both sonelokimab doses (120 mg: 43%, P<0.001; 240 mg: 35%, P=0.007) versus placebo (15%). Responses increased or were maintained through week 24. No new safety signals were identified. LIMITATIONS: MIRA was a 24-week study; ongoing phase 3 trials will assess longer-term efficacy and safety. CONCLUSIONS: Sonelokimab demonstrated high levels of clinical response in patients with moderate-to-severe HS and was well tolerated.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.