China-based Innovent Biologics (HKG: 1801) has announced the first subject dosing in the Phase III CLEAR study for its picankibart (IBI112), a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection, in moderate-to-severe plaque psoriasis. This marks a significant advancement in the development of innovative treatments for this chronic skin condition.
Phase III CLEAR Study Design
The multicenter, randomized, double-blind, placebo-controlled Phase III study (clinicaltrials.gov, NCT05645627) is designed to evaluate the efficacy and safety of picankibart in patients with moderate to severe plaque psoriasis. The study plans to enroll approximately 500 subjects with moderate to severe plaque psoriasis. After a 4-week screening period, eligible subjects will be randomized in a 2:2:1 ratio to one of three groups: picankibart group 1 (initial dose of 200mg and subsequently 200mg every 12 weeks), picankibart group 2 (initial dose of 200mg and subsequently 100mg every 12 weeks), or a placebo group. The research period is expected to last 68 weeks. The CLEAR study is the first Phase III clinical study of IL-23 class innovative drugs in China.
Mechanism of Action and Clinical Data
Picankibart specifically binds to the IL-23p19 subunit, thereby preventing IL-23 from binding to cell surface receptors, resulting in the inhibition of the IL-23 receptor-mediated signaling pathway. Preclinical data have demonstrated that picankibart has a clear target and well-elucidated mechanism of action, along with significant anti-inflammatory effects. Furthermore, good safety and tolerability have been demonstrated in the Phase I clinical study and confirmed in the completed Phase II clinical study, showing long-dose intervals and long-term efficacy advantages.-Fineline Info & Tech
