Johnson & Johnson announced positive topline results from the ICONIC-LEAD Phase 3 trial of icotrokinra (JNJ-2113), a first-in-class, once-daily oral peptide targeting the IL-23 receptor, for moderate to severe plaque psoriasis (PsO) in adults and adolescents. The study met its co-primary endpoints at week 16, demonstrating significant skin clearance as measured by Psoriasis Area and Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) of 0/1.
Efficacy and Safety Outcomes
In the ICONIC-LEAD trial, 64.7% of patients treated with icotrokinra achieved IGA scores of 0/1 (clear or almost clear skin) at week 16, compared to 8.3% on placebo. Additionally, 49.6% of patients on icotrokinra achieved PASI 90, versus 4.4% on placebo. Response rates continued to improve through week 24, with 74.1% of patients on icotrokinra reaching IGA 0/1 and 64.9% achieving PASI 90. The safety profile was consistent with previous Phase 2 studies, with similar rates of adverse events (AEs) observed between the icotrokinra (49.3%) and placebo (49.1%) groups at week 16.
ICONIC-TOTAL Study Results
Positive topline results were also reported from the Phase 3 ICONIC-TOTAL study, where once-daily icotrokinra met the primary endpoint of IGA 0/1 at week 16 compared to placebo. This trial focused on patients with moderate psoriasis affecting specific areas such as the scalp, genitals, hands, and feet.
Expert Commentary
"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," 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."
Ongoing Clinical Development
The Phase 3 ICONIC clinical development program includes ongoing studies such as ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which are evaluating the safety and efficacy of icotrokinra compared to both placebo and deucravacitinib in moderate-to-severe plaque PsO. Furthermore, the Phase 3 ICONIC-PsA program, investigating icotrokinra in psoriatic arthritis, is scheduled to begin in early 2025.
About Plaque Psoriasis
Plaque psoriasis is a chronic, immune-mediated disease characterized by the overproduction of skin cells, leading to inflamed, scaly plaques that can be itchy and painful. It affects an estimated eight million Americans and over 125 million people worldwide. Approximately one-quarter of individuals with plaque psoriasis experience moderate to severe forms of the condition. Plaques can appear anywhere on the body, but are most commonly found on the scalp, knees, elbows, and torso. The condition can significantly impact a person's quality of life, affecting emotional health, relationships, and overall well-being.
About Icotrokinra (JNJ-2113)
Icotrokinra is an investigational, targeted oral peptide designed to selectively block the IL-23 receptor, which plays a key role in the inflammatory response associated with moderate-to-severe plaque psoriasis and other IL-23-mediated diseases. It binds to the IL-23 receptor with high affinity and demonstrates potent, selective inhibition of IL-23 signaling in human T cells. Icotrokinra was jointly discovered and is being developed under a license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc.
