Positive results from ICONIC-Lead Phase III trial of icotrokinra (JNJ-2113) for moderate to severe plaque psoriasis

The Phase III study met its co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) of 0/1 response at week 16 and response rates continued to improve through week 24 Once daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. At week 16, nearly two-thirds (64.7%) of patients treated with icotrokinra achieved IGA scores of 0/1 (clear or almost clear skin), and 49.6% achieved PASI 90, compared to 8.3% and 4.4% on placebo, respectively. Further increases in response rates continued to be observed at week 24, with 74.1% of patients treated with icotrokinra achieving IGA scores of 0/1, and 64.9% achieving PASI 90.  Safety data was found to be consistent with the Phase II FRONTIER 1 and 2 studies. A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo, with 49.3% and 49.1% of participants experiencing a treatment emergent adverse event (TEAE) at week 16.

Furthermore, positive topline results from the Phase III ICONIC-TOTAL study showed once daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo. Comprehensive results from ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at upcoming medical congresses and will be shared with health authorities in planned submissions.|

“We are excited to see impressive Phase III results with once-daily icotrokinra treatment aligned with our Phase II study of this first-in-class targeted oral peptide that selectively blocks the IL-23 receptor,” said Liza O’Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. “The majority of people living with moderate-to-severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies. Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis.”

Other studies in the Phase III ICONIC clinical development program are ongoing, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will evaluate the safety and efficacy of icotrokinra compared with both placebo and deucravacitinib in moderate-to-severe plaque PsO. The Phase III ICONIC-PsA program which will investigate icotrokinra in psoriatic arthritis will be initiated in the beginning of 2025.