Johnson & Johnson (J&J) said that the Phase 3 ICONIC-LEAD trial of icotrokinra (JNJ-2113) in the treatment of plaque psoriasis has met the co-primary endpoints.
Icotrokinra is a targeted oral peptide that selectively blocks the interleukin-23 (IL-23) receptor. It was jointly discovered and is being developed under a licensing and collaboration agreement between Protagonist Therapeutics and Johnson & Johnson.
The ICONIC-LEAD trial assessed JNJ-2113 in adults and adolescents aged 12 years of age and older with moderate to severe plaque psoriasis (PsO).
According to the results, the oral peptide met the co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) 0/1 scores at week 16.
Icotrokinra, which was administered daily once, showed significant skin clearance in adults and adolescents with moderate to severe plaque psoriasis. Results also continued to improve through week 24, said Johnson & Johnson.
Safety data were consistent with previous Phase 2 trials, FRONTIER 1 and FRONTIER 2, with similar rates of treatment-emergent adverse events (TEAEs) between icotrokinra and placebo.
Furthermore, the positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA 0/1 at week 16, outperforming placebo.
Comprehensive data from both the ICONIC-LEAD and ICONIC-TOTAL studies will be submitted to health authorities for review.
Johnson & Johnson innovative medicine immunodermatology disease area lead vice president Liza O’Dowd said: “We are excited to see impressive Phase 3 results with once-daily icotrokinra treatment aligned with our Phase 2 study of this first-in-class targeted oral peptide that selectively blocks the IL-23 receptor.
“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 ongoing studies in the Phase 3 ICONIC programme include ICONIC-ADVANCE 1 and 2, which are evaluating the safety and efficacy of JNJ-2113 versus placebo and deucravacitinib in moderate-to-severe plaque psoriasis.
Additionally, the Phase 3 ICONIC-PsA programme, investigating icotrokinra in psoriatic arthritis, is set to begin in early 2025.
The Phase 3 ICONIC clinical development programme for JNJ-2113 in moderate-to-severe plaque psoriasis began in Q4 2023 with two studies, ICONIC-LEAD and ICONIC-TOTAL.
