Phase III LATITUDE-PsO-3001 and -3002 trials: Zasocitinib in moderate-to-severe plaque PsO

Results from the randomized, multicenter, phase III LATITUDE-PsO-3001 (NCT06088043) and LATITUDE-PsO-3002 (NCT06108544) trials, evaluating zasocitinib in patients with moderate-to-severe plaque psoriasis (PsO), were presented by Melinda Gooderham at the European Academy of Dermatology and Venereology (EADV) 2026 Congress, September 30 – October 3, 2026, Vienna, AT. In LATITUDE-PsO-3001, patients (N = 693) were randomized 3:1:1 to receive zasocitinib, apremilast, or placebo. In LATITUDE-PsO-3002, patients (N = 1,108) were randomized 2:1:1 to receive zasocitinib, apremilast, or placebo. In both studies, patients receiving placebo were reassigned to receive zasocitinib if they were achieving below ≥75% reduction in Psoriasis Area and Severity Index (PASI75) from Week 16 onward. The co-primary endpoints were the proportion of patients attaining a static Physician’s Global Assessment (sPGA) score of 0/1 and PASI75 at Week 16. 

Key data: Zasocitinib improved efficacy outcomes vs apremilast and placebo at all timepoints assessed in both LATITUDE-PsO-3001 (zasocitinib, n = 416; apremilast, n = 137; placebo, n = 140) and LATITUDE-PsO-3002 (zasocitinib, n = 555; apremilast, n = 276; placebo, n = 277). At Week 16, a greater proportion of patients receiving zasocitinib vs apremilast achieved a PASI75 response in LATITUDE-PsO-3001 (75.7% vs 37.2%; p < 0.001) and LATITUDE-PsO-3002 (71.4% vs 33.0%; p < 0.001); significant improvements in response were observed from Week 4 in LATITUDE-PsO-3002 (p < 0.001). At Week 16, 71.4% vs 32.1% of patients receiving zasocitinib vs apremilast attained sPGA 0/1 in LATITUDE-PsO-3001 (p < 0.001) and 69.2% vs 29.7% of patients did so in LATITUDE-PsO-3002 (p < 0.001); significant improvements in response were observed from Week 4 in both LATITUDE-PsO-3001 (p < 0.01) and -3002 (p < 0.001). Improvements with zasocitinib vs apremilast were maintained through Week 24 in both trials (both p < 0.001). In a pooled safety analysis, 69.3% of patients receiving zasocitinib experienced any treatment-emergent adverse event (TEAE), including serious adverse events (SAEs) in 3.6% of patients through Week 24.  

Key learning: In the LATITUDE-PsO-3001 and -3002 trials, zasocitinib demonstrated significant improvements in disease activity at Week 24 vs apremilast in patients with moderate-to-severe plaque PsO, with no new safety signals identified. Zasocitinib will be assessed further in additional phase III studies (NCT06550076 and NCT06973291).