ClinicalTrials.gov posted results on 9 September 2026 for a completed Phase 2 study evaluating adalimumab and sonelokimab in adults with active moderate to severe hidradenitis suppurativa. At week 12, 36.4% of participants in the adalimumab group achieved HiSCR75, compared with 43.3% with sonelokimab 120 mg and 14.7% with placebo.

Background

The study evaluated sonelokimab, administered subcutaneously, against placebo in adults with moderate to severe hidradenitis suppurativa. Adalimumab was included as an intervention in the trial. The stated purpose was to assess clinical efficacy and safety for sonelokimab in this condition.

Trial design

This completed Phase 2 study, identified as NCT05322473, enrolled 234 participants with hidradenitis suppurativa. The listed interventions were sonelokimab, also called m1095, and adalimumab. Reported Part A groups included placebo, sonelokimab 120 mg, sonelokimab 240 mg, and adalimumab. The supplied record did not include primary-outcome entries.

Key results

At week 12, the percentage achieving HiSCR75 was 14.7% with placebo, 43.3% with sonelokimab 120 mg, 34.8% with sonelokimab 240 mg, and 36.4% with adalimumab. For HiSCR50, the corresponding percentages were 27.9%, 65.7%, 53.0%, and 57.6%.

The least-squares mean change from baseline in IHS4 at week 12 was −7.91 with placebo, with a standard error of 2.11; −19.32 with sonelokimab 120 mg, standard error 2.10; −14.55 with sonelokimab 240 mg, standard error 2.10; and −15.46 with adalimumab, standard error 2.97.

Cochran-Mantel-Haenszel analyses reported odds ratios of 4.823 (95% CI, 2.055 to 11.316; p=0.001), 3.133 (95% CI, 1.35 to 7.27; p=0.007), 4.998 (95% CI, 2.389 to 10.455; p=0.001), and 2.907 (95% CI, 1.419 to 5.956; p=0.003). Mixed-model repeated-measures analyses reported least-square mean differences of −11.42 (95% CI, −17.0 to −5.83; p=0.001) and −6.64 (95% CI, −12.24 to −1.04; p=0.02).

What this means

The posted results showed higher response percentages and larger numerical IHS4 reductions with both sonelokimab doses than with placebo at week 12. Adalimumab produced a HiSCR75 response of 36.4% and an IHS4 least-squares mean change of −15.46. The record supplied no adverse-event summary, so it does not establish comparative safety.

Source

Source: ClinicalTrials.gov, registry results for the completed Phase 2 evaluation of sonelokimab and adalimumab in active moderate to severe hidradenitis suppurativa, posted 9 September 2026. Available at clinicaltrials.gov/study/NCT05322473.