Socrodeucitinib in moderate-to-severe plaque PsO: Phase II trial results

Results from a randomized, double-blind, placebo-controlled, phase II trial (CTR20232241) evaluating socrodeucitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis (PsO) were published in the Journal of the European Academy of Dermatology and Venereology by Han et al. Patients were randomized to receive socrodeucitinib 6 mg (n = 42) or 12 mg (n = 43) once daily (QD), or placebo (n = 40). The primary endpoint was the proportion of patients achieving ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI75) at Week 12. 

Key data: At Week 12, significantly more patients receiving socrodeucitinib 6 mg (28.6%; p < 0.05) and 12 mg (72.1%; p < 0.001) achieved PASI75 vs placebo (7.5%). A greater proportion of patients receiving socrodeucitinib 12 mg vs placebo achieved PASI90 (46.5% vs 0%; p < 0.001) and PASI100 (11.6% vs 0%; p = 0.027). A greater proportion of patients achieved a static Physician's Global Assessment (sPGA) score of 0 or 1 in the socrodeucitinib 6 mg (33.3%; p = 0.011) and 12 mg (65.1%; p < 0.001) groups vs placebo (10.0%). Adverse events (AEs) were reported in 76.2%, 88.4%, and 70.0% of patients in the socrodeucitinib 6 mg, 12 mg, and placebo groups, respectively. The most frequently reported treatment-related AE (TRAE) was upper respiratory tract infection (URTI; 4.8%, 9.3%, and 5.0% in the 6 mg, 12 mg, and placebo groups, respectively). 

Key learning: Socrodeucitinib demonstrated significantly greater improvements in PsO severity vs placebo with a well-tolerated safety profile in patients with moderate-to-severe plaque PsO. The results support further evaluation of the 12 mg QD dose in a larger, ongoing phase III trial (NCT06672393).