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- Presentation
Pipeline of Emerging Hidradenitis Suppurativa Therapies in Phase 2 and 3 Trials
Description
The presentation reviewed the rapidly expanding pipeline of hidradenitis suppurativa (HS) therapies, emphasizing phase 2 and phase 3 trials and the growing number of studies over the past several years. It highlighted JAK inhibitors such as povorcitinib, upadacitinib, and topical ruxolitinib, noting generally meaningful improvements in abscess/inflammatory nodule counts and HiSCR response rates, with ongoing pediatric and adult phase 3 programs. It also covered IL-17 targeting sonelokimab, which showed promising phase 2 and early phase 3 results with improvements in HiSCR, draining tunnels, and higher response thresholds, including adolescent studies and long-term extensions. Additional mechanisms discussed included IL-1 blockade with lutikizumab, which showed dose-dependent efficacy but also safety concerns; BTK inhibition with remibrutinib, which showed encouraging early efficacy in phase 2 and is now in phase 3; and IL-36 inhibition with spesolimab, which had mixed results and no clear phase 3 success. Finally, the talk briefly mentioned other emerging approaches such as IL-1 pathway modulators, anti-NET therapy, interferon blockade, and dual-target biologics, concluding that HS research is rapidly advancing and offers substantial hope for improved future treatments.
View moreConclusions
- The hidradenitis suppurativa therapeutic pipeline is expanding rapidly, with a sharp increase in clinical trials and a sense that the field is entering an especially active period.
- Several JAK inhibitors, especially povorcitinib and upadacitinib, show meaningful improvements in HS lesion counts and HiSCR responses, supporting continued phase 3 development.
- Topical ruxolitinib appears promising for mild-to-moderate HS, with high response rates in early studies and ongoing larger trials to confirm benefit.
- Sonelokimab, an IL-17A/F-targeting nanobody, has shown encouraging efficacy in phase 2 and phase 3 studies, including improvements in HiSCR and draining tunnels.
- Lutikizumab, an IL-1 alpha/beta inhibitor, demonstrated signal of efficacy after anti-TNF failure, with stronger results at some dosing schedules and acceptable early safety overall.
- Remibrutinib, a selective BTK inhibitor, produced favorable phase 2 outcomes in HiSCR and draining tunnel reduction and is now being tested in larger phase 3 trials.
- Spesolimab did not clearly meet its primary phase 3 endpoint for HS, suggesting IL-36 blockade may have limited overall efficacy in this disease despite some improvements in secondary outcomes like tunnels and pain.
- Although many agents show benefit, the most consistent gains appear to be in inflammatory lesion counts, HiSCR thresholds, and draining tunnel improvement rather than complete remission.
- Safety data across the pipeline are generally manageable so far, but ongoing trials are important to better define adverse events for long-term and broader use.
- The growing number of ongoing studies and off-label options suggests that patients with HS may soon have more targeted and potentially more effective treatment choices than before.
- Future progress will likely come from both additional pathway-specific drugs and dual-target therapies designed for refractory disease.
- Kirby et al., JAAD, 2024.
- Ackerman et al., JAAD, 2025.
- Porter et al., JAAD, 2026.
- Porter et al., JAAD, 2026.
- MoonLake Immunotherapeutics news release, September 28, 2025.
- MoonLake Immunotherapeutics news release, November 5, 2025.
- Alavi et al., BJD, 2024.