In a Phase 3 clinical trial, Icotrokinra demonstrated significant skin clearing in hard-to-treat scalp and genital psoriasis patients. At the 2025 Society for Investigative Dermatology (SID) Annual Meeting, the trial indicated that 66% of scalp psoriasis and 77% of genital psoriasis patients had clear or nearly clear skin after 16 weeks of treatment.
The trial included adult and adolescent participants (12 or older) who had at least moderate plaque psoriasis on skin areas of high impact. Primary objective was Investigator’s Global Assessment (IGA) rating of 0/1 (almost clear to clear skin) and ≥2-grade improvement on baseline at Week 16. 57% of the patients receiving once daily icotrokinra were successful at reaching the objective, as opposed to just 6% on placebo treatment (P<0.001). Rates of skin clearing were also extremely high in the patients with psoriasis of the scalp (66% with the scalp-specific Investigator’s Global Assessment (ss-IGA) rating 0/1 vs 11% on placebo, P<0.001) and for those with penogenital (genitalia) psoriasis (77% with a static Physician’s Global Assessment of Genitalia (sPGA-G) rating 0/1 vs 21% on placebo, P<0.001). In the smaller subgroup that had hand and/or foot psoriasis, there was a higher rate of nummeric Week 16 skin clearings with treatment by icotrokinra (42% with a hand and/or foot Physician’s Global Assessment (hf-PGA) rating 0/1), as compared to placebo (26%).
Icotrokinra had an acceptable safety profile with similar numbers of patients with adverse events (50% in the icotrokinra arm and 42% in the placebo arm) and serious adverse events (0.5% and 1.9%, respectively) up to Week 16. There were no new safety concerns. Icotrokinra (JNJ-2113) is the first-of-a-kind experimental oral peptide that is a selective IL-23 receptor inhibitor. It is being developed by Protagonist Therapeutics, Inc. and Johnson & Johnson.
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