SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) reported new Phase 3 data showing its investigational oral therapy icotrokinra achieved superior skin clearance compared to deucravacitinib in patients with moderate-to-severe plaque psoriasis. The findings, from the ICONIC-ADVANCE 1 and 2 studies, were presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress.
In the head-to-head trials, icotrokinra met both primary endpoints, demonstrating significantly higher response rates at Weeks 16 and 24 versus deucravacitinib, while maintaining adverse event rates comparable to placebo. No new safety concerns were identified.
Complementary long-term data from the ICONIC-LEAD study, also presented at EADV, showed that icotrokinra sustained high levels of skin clearance through 52 weeks in both adult and adolescent patients. At Week 52, 84% of adults who remained on icotrokinra maintained a PASI 90 response compared to 21% on placebo. Among adolescents, 86% on continuous icotrokinra and 77% who switched from placebo achieved PASI 90 by Week 52.
“These head-to-head data clearly demonstrate superior complete skin clearance rates for icotrokinra compared to deucravacitinib,” said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health. “With higher response rates seen as early as Week 16 and increasing at Week 24, this novel oral peptide treatment has the potential to be an appealing new option for patients with moderate-to-severe plaque psoriasis.”
Johnson & Johnson also initiated ICONIC-ASCEND, the first Phase 3 trial to compare an oral therapy directly against an injectable biologic, ustekinumab, in psoriasis.
“The long-term data from ICONIC-LEAD continue to demonstrate the potential of icotrokinra to address the need for a novel targeted oral psoriasis treatment,” said Jennifer Soung, M.D., Director of Clinical Research at Southern California Dermatology.
Company executives said icotrokinra, if approved, could redefine treatment options by offering patients the efficacy of systemic therapy with the convenience of a once-daily oral pill.
“We’re excited to see the icotrokinra program continue to deliver robust and clinically meaningful results,” said Liza O’Dowd, M.D., Vice President, Immunodermatology and Respiratory Disease Areas Lead at Johnson & Johnson Innovative Medicine. “A novel oral therapy that combines complete skin clearance with a favorable safety profile may provide a valuable new option for patients and physicians.”
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