Protagonist Reports Positive Phase 3 Data For Icotrokinra, Achieves High Skin Clearance In Teens With Plaque Psoriasis

Protagonist Therapeutics has published new promising data for icotrokinra (JNJ-2113), an investigational oral therapy developed in collaboration with Johnson & Johnson for moderate-to-severe plaque psoriasis (PsO). The data comes from a subgroup analysis of ICONIC-LEADa, the first Phase 3 registrational trial to assess the efficacy and safety of an oral-systemic PsO treatment in adolescents and adults. Results were presented at the 2025 World Congress of Pediatric Dermatology (WCPD).

Dinesh V. Patel, PhD, President and Chief Executive Officer at Protagonist, said in a statement, “"We are thrilled with the data from the Phase 3 ICONIC LEAD subgroup analysis, which suggests icotrokinra may provide a novel first-line treatment option for moderate-to-severe plaque psoriasis in adolescents who have not yet received an advanced injectable therapy. Icotrokinra offers a unique combination of complete skin clearance and a favourable safety profile in a once-daily pill that aligns with the needs and preferences of adolescent patients struggling with the challenges of psoriasis's visible and uncomfortable nature. The icotrokinra data demonstrate the potential to become a first-line therapy for plaque psoriasis."

In the adolescent subgroup, icotrokinra showed high levels of skin clearance, significantly outperforming placebo. By Week 16, 84.1% of adolescents on icotrokinra achieved clear or almost clear skin (IGA 0/1), and 70.5% achieved a PASI 90 score, compared to 27.3% and 13.6% in the placebo group. These response rates improved by Week 24, with 86.4% reaching IGA 0/1 and 88.6% achieving PASI 90. Notably, 75% had obvious skin (IGA 0), and 63.6% reached PASI 100, indicating full resolution of symptoms.

Icotrokinra also showed a favourable safety profile, with fewer adverse events (AEs) reported among adolescents taking the drug than those on a placebo (50% vs. 73%). No new safety concerns were identified, reinforcing icotrokinra's potential as a first-in-class, targeted IL-23 receptor blocker that could offer a convenient, oral alternative to injectable biologics for young patients with moderate-to-severe PsO.