Headlines in Dermatology | Psoriasis

First Off: Johnson & Johnson Submits Application to EMA for Oral Icotrokinra in Psoriasis

Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for what could be the first-ever approval of icotrokinra, a first-in-class investigational targeted oral peptide for the treatment of moderate-to-severe plaque psoriasis in people aged 12 and up, the Company reports.

Icotrokinra is designed to block the interleukin (IL)-23 receptor.

The filing is based on data from four Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and adolescents 12 and older with moderate-to-severe psoriasis, demonstrating significant skin clearance and a favorable safety profile in a once-daily tablet (as previously established in the ICONIC-LEAD and ICONIC-TOTAL clinical studies). Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib (Sotyktu, BMS) in moderate-to-severe psoriasis. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.

Supporting Data

Data submitted to the EMA as part of the application include:

Results from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of an Investigator’s Global Assessment (IGA) score of 0/1 (Clear or Almost Clear skin) Psoriasis Area and Severity Index (PASI) 90 compared to placebo at Week 16.
A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated adolescents treated with once-daily icotrokinra achieved higher rates of Clear or Almost Clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.
Data from the Phase 3 ICONIC-TOTAL study, presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.
Results from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile, met co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe psoriasis.
Long-term data from the ICONIC development program, including at least 52 weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting.

In addition, Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCEND study, the first head-to-head study seeking to demonstrate the superiority of an oral tablet, icotrokinra, compared to an injectable biologic, ustekinumab, and placebo.