Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies
Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study
Robust findings continue to demonstrate the potential of icotrokinra to disrupt the treatment paradigm to set a new standard for treating patients with moderate-to-severe plaque psoriasis
SPRING HOUSE, Pa. (September 17, 2025) – Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies which assessed the superiority of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, compared to deucravacitinib in patients with moderate-to-severe plaque psoriasis. These data are being presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress.1 Additionally, new long-term 52-week data from the Phase 3 ICONIC-LEAD study investigating icotrokinra in adults and pediatric patients 12 years of age and older (adolescents) with moderate-to-severe plaque psoriasis will be presented as a late-breaking abstract at EADV.2
Icotrokinra met both co-primary endpoints compared to placebo at Week 16 with similar adverse event rates and showed superiority to deucravacitinib at multiple timepoints in adult patients in the ICONIC-ADVANCE 1 and 2 studiesa
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Icotrokinra showed superior skin clearance vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24).1
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Icotrokinra demonstrated similar adverse event rates (AEs) to placebo, with no new safety signals identified. Icotrokinra AE rates were numerically lower vs deucravacitinib through Week 24.1
“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 and ICONIC-ADVANCE study investigator.b “With significantly higher response rates seen as early as Week 16 and increasing at Week 24, this novel targeted oral peptide treatment has the potential to be an appealing new option for patients with moderate-to-severe plaque psoriasis.”
Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCEND study,c the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, in psoriasis, representing an important step forward in psoriasis research.
Icotrokinra demonstrated sustained skin clearance and a favorable safety profile through Week 52 with no new safety signals identified in the ICONIC-LEADd drug withdrawal/re-retreatment study
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At Week 52, adult icotrokinra PASI 90 responders re-randomized to icotrokinra at Week 24 had superior maintenance of PASI 90 response versus those re-randomized to placebo (84% vs 21%; p<0.001).2, e
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At Week 52, 86% of adolescents who received icotrokinra for the full 52 weeks and 77% of those switched from placebo to icotrokinra at Week 16 achieved PASI 90 response.2
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ICONIC-LEAD Week 16 primary endpoint data was previously presented at the American Academy of Dermatology 2025 Congress.3
“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 and ICONIC-LEAD study investigator.b “With a substantial proportion of adults and adolescents achieving clear or almost clear skin while maintaining a favorable safety profile through 52 weeks, icotrokinra could be a compelling new therapeutic option that aligns with both patient and provider goals for an oral treatment once approved.”
“We’re excited to see the icotrokinra Phase 3 ICONIC program continue to deliver robust and clinically meaningful head-to-head and long-term results,” said Liza O’Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Areas Lead, Johnson & Johnson Innovative Medicine. “A novel oral therapy that can provide complete skin clearance, a favorable safety profile and the simplicity of a once daily pill may offer an important new option that could increase the use of systemic treatments among patients with moderate-to-severe plaque psoriasis.”
For further details and the full list of data presented at the 2025 EADV Congress, visit https://innovativemedicine.jnj.com/focus-areas/immunology/immudermatology-newsroom
Editor’s notes:
a. ICONIC- ADVANCE 1 and 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque PsO with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints.
b. Drs. Soung and Stein Gold are paid consultants for Johnson & Johnson. They have not been compensated for any media work.
c. ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.4
d. ICONIC-LEAD is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque PsO, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients 12 years of age and older.
e. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness. PASI 90 means a 90% reduction in baseline PASI score.
About the ICONIC Clinical Development Program
The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and pediatric patients 12 years of age and older 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 & Johnson company.5
ICONIC-LEAD ( NCT06095115) is a 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 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.14 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, including ICONIC-ASCEND; the ICONIC-PSA 1 and ICONIC-PSA 2 studies in 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.
Footnotes
1 Stein Gold, L et al. Icotrokinra Demonstrated Superior Responses Compared with Placebo and Deucravacitinib in the Treatment of Moderate-to-Severe Plaque Psoriasis : Results Through Week 24 of the Phase 3 ICONIC-ADVANCE 1&2 Studies. Oral presentation (Presentation FC01.1G) at the European Academy of Dermatology and Venereology Congress (EADV). September 2025.
2 Soung, J et al. Maintenance of Response with Icotrokinra, a Targeted Oral Peptide, for the Treatment of Moderate-to-Severe Psoriasis : Randomized Treatment Withdrawal in Adults (weeks 24-52) and Continuous Treatment in Adolescents (Through Week 52) From the Phase 3, ICONIC-LEAD Trial. Late-breaking research oral presentation (Presentation #D1T01.2B) at the European Academy of Dermatology and Venereology Congress (EADV). September 2025.
3 Bissonnette, R et al. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results Through Week 24 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-LEAD Trial. Late-breaking research presentation (Abstract #66708) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.
4 Clinicaltrials.gov. A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. https://clinicaltrials.gov/study/NCT06934226?term=iconic-ascend&rank=1. Accessed July 2025.
5 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: https://www.accesswire.com/791174/protagonist-announces-advancement-of-jnj-2113-across-multiple-indications. Accessed July 2025.
6 Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. https://classic.clinicaltrials.gov/ct2/show/NCT06095115. Accessed July 2025.
7 Clinicaltrials.gov. A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. https://classic.clinicaltrials.gov/ct2/show/NCT06095102. Accessed July 2025.
8 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10. Accessed July 2025.
9 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. https://clinicaltrials.gov/study/NCT06220604. Accessed July 2025.
10 Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. https://clinicaltrials.gov/study/NCT06878404
11 A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. https://clinicaltrials.gov/study/NCT06807424
12 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed July 2025.
13 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed July 2025.
14 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/. Accessed July 2025.
15 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed July 2025.
16 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed July 2025.
17 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.
18 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.
19 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
20 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.
21 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease. Accessed July 2025.
22 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed July 2025.
23 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed July 2025.
24 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed July 2025.