Johnson & Johnson's Oral IL-23R Antagonist Icotrokinra Outperforms BMS’s Sotyktu in Phase 3 Trials for Moderate-to-Severe Plaque Psoriasis

In the field of psoriasis treatment, a new competition is quietly unfolding. Johnson & Johnson (J&J) recently announced that its orally-administered IL-23 receptor blocker, Icotrokinra, achieved remarkable results in Phase III clinical trials. It is expected to become the new standard for psoriasis treatment and directly challenge Bristol-Myers Squibb's (BMS) Sotyktu.

Clinical Manifestations of Icotrokinra: Significant Efficacy, Good Safety

According to the announcement by J&J, Icotrokinra not only outperformed the placebo in the phase III clinical trials ICONIC-ADVANCE 1 & 2 but also surpassed BMS's Sotyktu on key indicators. This outcome positions Icotrokinra as a promising new option for psoriasis treatment.

In another key trial, ICONIC-LEAD, presented at the 2025 American Academy of Dermatology Annual Meeting, the efficacy data of Icotrokinra was particularly impressive: Among patients with moderate to severe psoriasis receiving Icotrokinra treatment, 65% achieved clear or almost clear skin within 16 weeks, compared to only 8% in the placebo group. Additionally, 50% of patients in the Icotrokinra group achieved a 90% improvement in disease symptom severity within 16 weeks, compared to only 4% in the placebo group. This data indicates that Icotrokinra has a significant advantage in improving psoriasis symptoms.

Meanwhile, the skin clearance effect in the Icotrokinra group continued to improve over the 24-week follow-up period, demonstrating good persistence. In terms of safety, the incidence of adverse events was comparable between the Icotrokinra and placebo groups, both at 49%, showing good tolerability.

In contrast, in the POETYK PsA-2 Phase III clinical trial of BMS's Sotyktu for psoriatic arthritis, 54.2% of patients in the treatment group showed at least a 20% improvement in symptoms and signs within 16 weeks, compared to 39.4% in the placebo group, with a statistically significant treatment difference (p-value of 0.0002). Despite Sotyktu's remarkable achievements in the field of psoriasis treatment, the emergence of Icotrokinra undoubtedly presents a new challenge.

The development of Icotrokinra began in 2017, when Johnson & Johnson (J&J) entered into a collaboration with Protagonist Therapeutics, acquiring the rights to develop this oral peptide IL-23 receptor antagonist. Under the agreement, Protagonist Therapeutics received a $50 million upfront payment and is eligible for up to $940 million in potential milestone payments.

Icotrokinra is an oral peptide therapy capable of targeting and selectively inhibiting the IL-23 receptor. The IL-23 receptor plays a crucial role in the pathological inflammation associated with diseases such as psoriasis and ulcerative colitis. In addition to research on psoriasis, Johnson & Johnson is also conducting the Phase IIb ANTHEM-UC study of Icotrokinra for ulcerative colitis.

J&J Plans to Further Conduct Phase III ICONIC-ASCEND Trial, Directly Comparing Icotrokinra with Its Blockbuster Antibody Drug Stelara (an Injectable Biologic). This Trial Will Further Validate the Potential of Icotrokinra in the Psoriasis Treatment Field.

Johnson & Johnson previouslyIt was previously estimated that the annual peak sales of Icotrokinra could exceed $5 billion.

The emergence of Icotrokinra has undoubtedly introduced new dynamics into the field of psoriasis treatment. Since its approval in September 2022, BMS's Sotyktu has secured a position in the market due to its relatively favorable safety profile. However, Icotrokinra not only demonstrates advantages in efficacy but also matches Sotyktu in terms of safety. This competition will not only drive innovation in psoriasis treatment but also provide patients with more options.