Late-stage data also showed that Johnson & Johnson’s icotrokinra was superior to Bristol Myers Squibb’s Sotyktu at clearing skin and easing symptom severity in patients with plaque psoriasis.
Johnson & Johnson is stepping up to challenge Bristol Myers Squibb in plaque psoriasis, with a recent late-stage readout positioning its investigational IL-23 receptor blocker icotrokinra to become a “new standard of treatment” in the indication, according to the pharma.
Over the weekend, J&J announced that topline findings from the Phase III ICONIC-ADVANCE 1 & 2 trials show that icotrokinra not only bested placebo at achieving skin clearance and improving symptom severity but also had superior outcomes to BMS’ oral TYK2 blocker Sotyktu, which won the FDA’s approval in September 2022.
J&J is developing icotrokinra through a licensing collaboration with Protagonist Therapeutics. Signed in 2017, the deal gave the biotech $50 million upfront plus $940 in potential milestones for the oral peptide IL-23 receptor antagonist in inflammatory bowel disease and other indications.
Meanwhile, in a late-breaking abstract Saturday at the 2025 annual meeting of the American Academy of Dermatology, J&J also unveiled data from its Phase III ICONIC-LEAD study, which showed that 65% of icotrokinra-treated patients with moderate-to-severe plaque psoriasis achieved clear or almost-clear skin at 16 weeks, versus 8% of placebo comparators. At the same time point, half of patients in the icotrokinra arm saw a 90% improvement in the severity of disease symptoms, as compared with 4% in the placebo arm.
Skin clearance in the icotrokinra group persisted and showed continued improvement through 24 weeks of follow-up, according to J&J’s news release. Safety findings were comparable between the icotrokinra and placebo arms—adverse events occurred in 49% of participants in either group.
In a note to investors on Sunday, analysts at Guggenheim Partners said that they were “impressed” with icotrokinra’s efficacy, while the safety profile “appears very reasonable.” The company has previously estimated annual peak sales of $5 billion or more, with Guggenheim adding that “the profile emerging for the product certainly seems to support that view.”
The decision to test icotrokinra against other established drugs in this space, according to the Guggenheim analysts, points to “the confidence the team has in icotrokinra.”
J&J now plans to launch the Phase III ICONIC-ASCEND trial, which will directly pit icotrokinra against its own blockbuster antibody Stelara, an injectable biologic.
Designed to be taken orally, icotrokinra is a peptide therapy that targets and selective inhibits the IL-23 receptor, a key player in the pathologic inflammation seen in diseases such as plaque psoriasis and ulcerative colitis. For the latter indication, J&J is running the Phase IIb ANTHEM-UC study of icotrokinra.
In plaque psoriasis, icotrokinra will again go up against BMS’ Sotyktu, which has distinguished itself from other therapies in this space with its relatively clean safety profile. Last month, BMS released long-term data for the drug, touting a safety profile that remained consistent through five years and more than 5,000 patient-years of follow-up.
