Picankibart Shows Skin Clearance in Plaque Psoriasis: Analysis
Key Takeaways
- Picankibart met both co-primary endpoints in the phase III CLEAR-1 trial, with significantly higher PASI 90 and sPGA 0/1 response rates than placebo at Week 16.
- Clinical responses were maintained through Week 52 using every-12-week maintenance dosing with either 100 mg or 200 mg, with no new safety signals reported.
- The study was conducted exclusively in Chinese patients and did not include an active comparator, limiting generalizability.
A phase III study published in the Journal of the American Academy of Dermatology found that picankibart, an investigational interleukin (IL)-23p19 inhibitor, produced high rates of skin clearance with durable efficacy through 52 weeks in adults with moderate-to-severe plaque psoriasis.
The multicenter, randomized, double-blind, placebo-controlled CLEAR-1 trial enrolled Chinese adults aged 18 to 75 years who received picankibart 200 mg throughout treatment, picankibart 200 mg followed by 100 mg maintenance dosing, or placebo with crossover to active treatment after Week 16. Primary endpoints included achievement of at least 90% improvement in Psoriasis Area and Severity Index (PASI 90) and static Physician's Global Assessment (sPGA) scores of 0/1 at Week 16.
Ongoing Maintenance Dosing Sustaines Responses Through One Year
At Week 16, 80.3% of patients receiving picankibart 200 mg achieved PASI 90 compared with 2.0% in the placebo group. Additionally, 93.5% of treated patients achieved sPGA 0/1 versus 13.1% with placebo. All key secondary endpoints favored picankibart, which showed improvements across efficacy measures (all two-sided P < 0.0001). Clinical responses were maintained through Week 52 with both the 100-mg and 200-mg every-12-week maintenance regimens. Investigators also reported no new safety signals during one year of follow-up.
The authors noted that sustained complete or near-complete skin clearance with reduced-frequency dosing remains an important treatment goal for patients with moderate-to-severe plaque psoriasis.
Cited limitations included enrollment exclusively in Chinese participants and the absence of an active comparator.
Source
Gao Y, et al. Journal of the American Academy of Dermatology. 2026. Doi:10.1016/j.jaad.2026.04.001