Picankibart Phase III Trial Reports Week 16 Clearance and Week 52 Durability

Key Takeaways

• At week 16, both co-primary endpoints favored picankibart over placebo in Chinese adults with moderate to severe plaque psoriasis.
• All key secondary endpoints also improved, and efficacy was maintained through week 52 with both 100 mg and 200 mg every-12-week dosing.
• No new safety signal was observed, and the trial was limited to Chinese participants without an active comparator.

In Chinese adults with moderate to severe plaque psoriasis, 80.3% on 200 mg picankibart reached PASI 90 at week 16 versus 2.0% on placebo in the CLEAR-1 phase III trial. The second co-primary endpoint also favored active treatment at week 16, showing a similar pattern across the two prespecified measures. Picankibart, an interleukin-23p19 inhibitor, was compared with placebo during the initial treatment period before crossover dosing began.

CLEAR-1 was a multicenter, randomized, double-blinded, placebo-controlled phase III trial in Chinese patients aged 18 to 75 years with moderate to severe plaque psoriasis. One group received subcutaneous picankibart 200 mg at weeks 0, 4, 8, 20, 32, and 44. A second group received 200 mg at weeks 0, 4, and 8, then 100 mg at weeks 20, 32, and 44. The placebo group was treated at weeks 0, 4, and 8, then crossed to picankibart 200 mg at weeks 16, 20, 24, 32, and 44. The co-primary endpoints were PASI 90 and static Physician’s Global Assessment clear or almost clear status at week 16.

At week 16, 80.3% of the 200 mg group achieved PASI 90, compared with 2.0% of placebo recipients. Static Physician’s Global Assessment clear or almost clear status was reached by 93.5% in the 200 mg group and 13.1% with placebo. All key secondary endpoints also improved significantly versus placebo, with two-sided P < .0001 across those comparisons. These results came from the placebo-controlled portion before crossover treatment began in the control arm. Together, the week 16 findings showed clear separation across the prespecified randomized endpoints.

Efficacy was maintained through week 52 with both the 100 mg and 200 mg doses. Week 16 skin clearance was sustained through week 52 with every-12-week dosing using either dose. Both maintenance regimens followed the every-12-week schedule described after the initial induction doses. No new safety signal was observed during the reported follow-up.