SSGJ-608 highly effective for moderate-to-severe plaque psoriasis with comparable efficacy across two dosing regimens

Plaque psoriasis is a chronic inflammatory skin condition impacting millions globally, often requiring systemic therapies for moderate-to-severe cases. Current treatments, while effective, can have varying response rates and require optimized dosing strategies. SSGJ-608, a highly specific anti-interleukin-17A monoclonal antibody, has shown promising preliminary efficacy. This phase 3 trial aimed to confirm its effectiveness and compare two distinct dosing regimens in a larger patient cohort, addressing the need for refined treatment protocols and improved patient outcomes.

A multicenter, randomized, open-label, phase 3 trial enrolled 770 patients with moderate-to-severe plaque psoriasis. Patients were randomized (1:1) to receive subcutaneous injections of SSGJ-608 80mg every two weeks (Q2W) after a 160mg starting dose at week 0 (608A group), or SSGJ-608 160mg every four weeks (Q4W) (608B group) for 12 weeks. Efficacy was assessed by PASI75 and sPGA 0 or 1 response rates at week 12 as co-primary endpoints, with PASI90, PASI100, and sPGA 0 as secondary endpoints. Safety was also evaluated.

At week 12, both SSGJ-608 dosing regimens demonstrated high and comparable efficacy. > The proportions of patients achieving PASI75 were 92.7% in the 80mg Q2W group and 95.1% in the 160mg Q4W group, while sPGA 0/1 response rates were 80.3% and 79.0%, respectively. Secondary endpoints also showed robust responses: PASI90 rates were 81.0% (Q2W) vs. 82.3% (Q4W), PASI100 rates were 49.4% vs. 47.5%, and sPGA 0 rates were 49.4% vs. 47.3%. Notably, SSGJ-608 achieved high clinical response rates at week 12 even in the subgroup of patients previously treated with anti-IL-17 therapy. The most common treatment-emergent adverse events (TEAEs) included hypertriglyceridemia, upper respiratory tract infection, hyperuricemia, increased alanine aminotransferase, and hypercholesterolemia. Both groups exhibited a favorable safety profile with no new safety signals identified.