Johnson & Johnson (NYSE: JNJ) today announced promising new results from the Phase 3 ICONIC-TOTAL study evaluating icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide designed to selectively block the IL-23 receptor. The study included adults and adolescents (12 years and older) with moderate plaque psoriasis (PsO), even with as little as 1% body surface area involvement, focusing on high-impact skin sites.
At the 2025 Society for Investigative Dermatology (SID) Annual Meeting, data showed that 57% of patients treated once daily with icotrokinra achieved the study’s primary endpoint: an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin) with a ≥2-grade improvement from baseline at Week 16, compared to just 6% on placebo (P<0.001).¹
High Clearance Rates in Challenging Areas
Icotrokinra demonstrated particularly strong results in hard-to-treat areas:
- Scalp psoriasis: 66% of patients achieved a scalp-specific IGA (ss-IGA) score of 0/1 vs. 11% on placebo (P<0.001).
- Genital psoriasis: 77% reached a static Physician’s Global Assessment of Genitalia (sPGA-G) score of 0/1 vs. 21% on placebo (P<0.001).
- Hand/foot psoriasis: In a smaller subset, 42% achieved a hand and/or foot PGA (hf-PGA) score of 0/1 vs. 26% on placebo at Week 16.
“While plaque psoriasis can affect any part of the body, high-impact sites like the scalp, genitals, hands, and feet are particularly challenging to treat, often affecting mobility, self-care, and intimacy,” said Dr. Melinda Gooderham, MSc, MD, FRCPC, SKiN Centre for Dermatology, Queen’s University, and ICONIC-TOTAL investigator. “These findings show impressive clearance rates in these sensitive areas and highlight icotrokinra’s potential as a novel therapeutic option that aligns with patient needs and preferences.”
Favorable Safety Profile
Icotrokinra was well-tolerated, with similar rates of adverse events in the icotrokinra and placebo groups (50% vs. 42%) and low rates of serious adverse events (0.5% vs. 1.9%) through Week 16. No new safety concerns were identified.¹
“When psoriasis affects sensitive areas, it can profoundly impact a patient’s quality of life,” said Dr. Liza O’Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. “These new results build on the strong scalp psoriasis data from ICONIC-LEAD and reinforce icotrokinra’s potential to transform the treatment landscape in moderate-to-severe plaque psoriasis, offering patients both skin clearance and the convenience of a once-daily oral therapy.”
The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and adolescent individuals with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.5
ICONIC-LEAD (NCT06095115) is a randomized controlled trial (RCT) to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.6
ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.7
Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.8,9 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.10,11
About Plaque Psoriasis
Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.12 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.13 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.14 On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale.14 On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color.15 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.15 Living with plaque PsO can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life.15 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.15,16
About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,17 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.18,[19] Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.20 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.21
Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.22,23,24
Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
