ClinicalTrials.gov posted results on 7 November 2024 for a Phase 3 study of deucravacitinib in participants with active psoriatic arthritis. The trial enrolled 729 participants and reported Week 16 measurements including 169 participants meeting ACR20 with deucravacitinib versus 123 participants with placebo.

Background

The study evaluated deucravacitinib, also known by the brand name Sotyktu, for active psoriatic arthritis. It included participants who were naïve to biologic disease-modifying antirheumatic drugs or who had previously received a TNFα inhibitor. The listed interventions were deucravacitinib and apremilast, while the study summary described evaluation against placebo. A long-term extension period was intended to provide additional safety and efficacy information.

Trial design

This Phase 3 study, identified as NCT04908189, enrolled 729 participants with psoriatic arthritis and had an overall status of active, not recruiting. The study evaluated safety and efficacy in active PsA, with Week 16 measures covering ACR20, DAS28-CRP, HAQ-DI, PASI 75, SF-36 physical component score, and enthesitis resolution. The supplied record does not list primary-outcome entries.

Key results

At Week 16, 169 participants in the deucravacitinib group and 123 participants in the placebo group met ACR20. PASI 75 was reported for 63 participants receiving deucravacitinib and 23 participants receiving placebo. Among participants with enthesitis at baseline, enthesitis resolution was reported for 74 participants with deucravacitinib and 66 participants with placebo.

Mean DAS28-CRP change was -1.3133 with deucravacitinib, with a standard deviation of 1.17420, versus -0.9095 with placebo, with a standard deviation of 1.10470. Mean HAQ-DI change was -0.3103 versus -0.2219, respectively. SF-36 physical component score change was 6.194 with deucravacitinib and 4.262 with placebo.

The record included six ANCOVA analyses. Reported adjusted mean differences were -0.4743 with a 95% confidence interval of -0.6455 to -0.3031 and p=0.0001; -0.1126 with a 95% confidence interval of -0.1814 to -0.0438 and p=0.0013; and 2.042 with a 95% confidence interval of 0.98 to 3.105 and p=0.0002. Other analyses reported adjusted mean differences of 0.8, 0.0643 at Week 2, and 0.0085 at Week 4, with p-values of 0.2017, 0.0231, and 0.7865, respectively.

What this means

The posted Week 16 measurements showed higher reported counts for ACR20 and PASI 75 with deucravacitinib than with placebo, alongside greater mean changes in DAS28-CRP, HAQ-DI, and SF-36 physical component score. The record does not provide labels linking each ANCOVA analysis to a specific outcome, and it includes no adverse-event summary. These results describe the posted trial measurements but do not establish a regulatory decision.

Source

Source: ClinicalTrials.gov, registry results for the Phase 3 study “A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis,” posted 7 November 2024. Available at clinicaltrials.gov/study/NCT04908189.