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Efficacy and Safety of oral TYK2 Inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis: A phase II, randomised, double-blinded, placebo-controlled trial.
Source: innocarepharma.com
Quote:
The study results demonstrated that ICP-488 is highly effective in treating psoriasis patients at both 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for moderate-to-severe psoriasis patients.
A total of 129 psoriasis patients were randomized into three groups to receive once daily oral doses of ICP-488 at 6 mg, 9 mg, or placebo for twelve weeks. The primary endpoint was the percentage of subjects who achieved at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score (PASI 75) at week 12.
At week 12, the percentage of patients achieving PASI 75 was significantly superior in the ICP-488 6 mg QD group (77.3%) and the 9 mg QD group (78.6%) than that of the placebo group (11.6%) (P<0.0001); the percentages of subjects achieving PASI 90 and sPGA of 0 (clear) or 1 (almost clear) were also significantly higher in the ICP-488 6 mg QD group (36.4%, 70.5%) and 9 mg QD group (50.0%, 71.4%) compared to the placebo group (0%, 9.3%)(P<0.0001). All treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) and were mild or moderate.
Source: innocarepharma.com