Trial results for a Phase 2 study evaluating deucravacitinib (Sotyktu) for hidradenitis suppurativa (HS) were posted on ClinicalTrials.gov on 2026-05-29. The study was terminated, and initial data indicated that the placebo arm showed a greater median reduction in inflammatory lesions (-9.0) compared to the deucravacitinib arm (-2.0).
Background
Deucravacitinib (Sotyktu) was being investigated for the treatment of hidradenitis suppurativa (HS), a chronic inflammatory skin condition.
Trial design
The terminated Phase 2 study (NCT05997277) enrolled 7 participants with hidradenitis suppurativa (HS). This randomized, double-blind, parallel-group, proof-of-concept study aimed to evaluate the safety and efficacy of deucravacitinib compared to placebo. Participants were intended to receive deucravacitinib 6 mg orally twice daily for 16 weeks, following a 4-week screening period and preceding a 4-week follow-up period.
Key results
The trial reported median changes from baseline in the number of inflammatory lesion counts at Week 16:
- In the Deucravacitinib group, the median change from baseline was -2.0 inflammatory lesions.
- In the Placebo group, the median change from baseline was -9 inflammatory lesions.
What this means
The termination of this Phase 2 study with a limited enrollment of 7 participants means that comprehensive efficacy data for deucravacitinib in hidradenitis suppurativa is not available from this trial. The reported median changes in inflammatory lesion counts at Week 16 show that the placebo group experienced a numerically greater reduction (-9 inflammatory lesions) compared to the deucravacitinib group (-2.0 inflammatory lesions). This early termination and the observed numerical difference suggest that the study did not demonstrate a positive signal for deucravacitinib over placebo for this specific outcome in the small number of participants evaluated. Further research would be needed to assess the potential of deucravacitinib for hidradenitis suppurativa.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05997277, titled "Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS)", were posted on 2026-05-29 on clinicaltrials.gov.