Johnson & Johnson’s icotrokinra demonstrates superiority in plaque psoriasis trials, setting stage for market disruption

New clinical trial data from Johnson & Johnson suggests that icotrokinra results could mark a major shift in plaque psoriasis treatment, demonstrating strong efficacy and a favorable safety profile. The investigational oral drug has outperformed current treatment options in key Phase 3 study results, with nearly half of patients achieving completely clear skin at 24 weeks.

Presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, these findings introduce the possibility of an oral therapy that rivals injectable biologics, potentially altering how moderate-to-severe plaque psoriasis treatment is approached. With regulatory approval pending, the latest trial outcomes provide a compelling case for icotrokinra’s future role in dermatology.

What Do the Latest Icotrokinra Phase 3 Results Reveal?

The Phase 3 study, ICONIC-LEAD, evaluated the efficacy of icotrokinra, a first-in-class targeted oral peptide designed to block the IL-23 receptor. The results revealed that 65% of patients achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin), while 50% recorded a 90% improvement in their Psoriasis Area and Severity Index (PASI 90) at 16 weeks. By 24 weeks, 74% of patients had IGA 0/1, and 65% achieved PASI 90, demonstrating continued improvement. Nearly half of patients reached complete skin clearance, with 46% achieving IGA 0 and 40% reaching PASI 100.

In addition to efficacy, safety remains a critical factor in systemic plaque psoriasis treatment. The trial reported no new safety signals, with adverse event rates in the icotrokinra and placebo groups remaining comparable at 49%. These findings suggest that icotrokinra’s mechanism of selectively blocking IL-23 may provide a more targeted approach without the broader immunosuppressive risks associated with some biologics.

How Does Icotrokinra Compare to Existing Plaque Psoriasis Treatments?

The latest Phase 3 study results indicate that icotrokinra is not only effective but also superior to deucravacitinib, a widely prescribed treatment for plaque psoriasis treatment. The ICONIC-ADVANCE 1&2 trials confirmed that icotrokinra met all co-primary endpoints, achieving significantly higher rates of skin clearance at both 16 and 24 weeks compared to deucravacitinib.

The strong efficacy data positions icotrokinra as a potential first-line systemic therapy, offering patients an alternative to injectable biologics. With its once-daily oral formulation, the drug presents a convenient treatment option for individuals seeking to avoid injections while maintaining high efficacy levels.

Could Icotrokinra Replace Injectable Biologics?

Following the success of the ICONIC-ADVANCE trials, Johnson & Johnson has initiated the ICONIC-ASCEND study, marking the first head-to-head trial comparing an oral psoriasis treatment to an injectable biologic. The study will assess whether icotrokinra can outperform ustekinumab, an established IL-23 inhibitor.

If the results confirm icotrokinra’s superiority, the drug could shift market dynamics by offering patients a non-injectable alternative with comparable or enhanced efficacy. This development may influence treatment guidelines, physician prescribing patterns, and even insurance coverage policies, potentially positioning icotrokinra as a preferred option in plaque psoriasis treatment.

What Are the Implications for the Plaque Psoriasis Market?

The success of icotrokinra in Phase 3 study trials could have a significant impact on the multi-billion-dollar psoriasis treatment market. Biologic drugs currently dominate this space, but the introduction of a highly effective oral therapy could disrupt established prescribing trends.

For Johnson & Johnson, icotrokinra represents a major opportunity to strengthen its presence in dermatology. The company’s investment in a first-in-class IL-23 receptor-blocking peptide underscores its strategic focus on developing innovative solutions that address both efficacy and convenience for patients.

With the potential for regulatory approvals in the near future, analysts are closely monitoring icotrokinra’s progress. The upcoming ICONIC-ASCEND results will be critical in determining whether the drug can challenge the dominance of biologic injections and reshape the landscape of plaque psoriasis treatment.

What’s Next for Icotrokinra?

As Johnson & Johnson advances the clinical development of icotrokinra, further studies will evaluate its application beyond plaque psoriasis treatment. Ongoing trials are exploring its effectiveness in conditions such as ulcerative colitis and psoriatic arthritis, where IL-23 plays a key role in disease progression.

With a strong safety profile, superior efficacy compared to existing oral treatments, and the potential to rival biologics, icotrokinra is emerging as a transformative therapy. If approved, it could become the first oral IL-23 inhibitor available for systemic plaque psoriasis treatment, setting a new standard for managing moderate-to-severe cases.

A New Era for Plaque Psoriasis Treatment?

The icotrokinra results from Phase 3 study trials indicate that the investigational drug has the potential to revolutionize plaque psoriasis treatment. By combining high efficacy with the convenience of an oral formulation, it offers a promising alternative to both traditional systemic therapies and injectable biologics.

As Johnson & Johnson progresses toward regulatory filings and the initiation of head-to-head biologic comparisons, the industry awaits further validation of icotrokinra’s superiority. If the drug continues to demonstrate strong results, it may redefine how moderate-to-severe psoriasis is treated, offering patients an effective and accessible treatment option.