BEERSE, Belgium (17 September, 2025) – Johnson & Johnson 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.1 These data were 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 paediatric patients 12 years of age and older (adolescents) with moderate to severe plaque psoriasis were 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 met the secondary endpoint by showing superiority to deucravacitinib at multiple timepoints in adult patients in the ICONIC-ADVANCE 1 and 2 studies.1,a
- Icotrokinra showed superior skin clearance rates vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24).1
- A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo groups, with no new safety signals identified.1 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 24,1 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 studyc the first head-to-head study seeking to demonstrate the superiority of an oral tablet, icotrokinra, compared to an injectable biologic, ustekinumab, versus placebo in psoriasis,3 representing an important step forward in psoriasis research.
Icotrokinra demonstrated sustained skin clearance and a favourable safety profile through Week 52 with no new safety signals identified in the ICONIC-LEADd drug withdrawal/re-retreatment study.2
- At Week 52, adult icotrokinra PASI 90 responders re-randomised to icotrokinra at Week 24 had superior maintenance of PASI 90 response versus those re-randomised to placebo (84% vs 21%; p<0.001).2,e
- 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
- ICONIC-LEAD Week 16 primary endpoint data was previously presented at the American Academy of Dermatology 2025 Congress.4
- Safety in ICONIC-LEAD participants with moderate-to-severe plaque psoriasis was consistent with that observed through Week 24.2 The safety profile of icotrokinra was shown to be favourable, relative to placebo, as previously established in the ICONIC-LEAD and ICONIC-TOTAL clinical studies.2,5
“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 favourable safety profile through 52 weeks,2 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 programme 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 significant skin clearance, a favourable 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.”
“Those living with psoriasis face many challenges beyond the physical manifestations,” said Dr Mark Graham, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “The latest results from our ICONIC clinical development programme demonstrate our commitment to continue driving new treatment options for patients so they can achieve better health outcomes and an improved quality of life.”
For further details and the full list of data presented at the 2025 EADV Congress, visit https://www.jnj.com/innovativemedicine/immunology/immunodermatology
Editor’s notes:
a. ICONIC- ADVANCE 1 and 2 are Phase 3 randomised clinical trials (RCTs) evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in 774 and 731 adult 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.1,6,7
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 head-to-head study seeking to demonstrate the superiority of an oral tablet, icotrokinra, compared to an injectable biologic, ustekinumab and placebo in moderate-to-severe plaque Pso.3
d. ICONIC-LEAD is a Phase 3 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.2,4,8
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.9
About the ICONIC Clinical Development Program
The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and paediatric 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 & Johson company.10
ICONIC-LEAD ( EudraCT: 2023-505120-59-00, 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.8,11
ICONIC-TOTAL ( EudraCT: 2023-505122-34-00, 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.12,13
Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 ( EudraCT:2023-505121-14; NCT06220604) 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.6,7,14 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis.3 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.15,16
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.17 It is estimated that 6.4 million people in Europe and more than 125 million people worldwide live with the disease.18,19 Nearly one-quarter of all people with plaque Pso have cases that are considered moderate-to-severe.19 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales.20 Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones.20 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.20 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.21 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.21,22
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,23 which underpins the inflammatory response in moderate-to-severe plaque Psoriais (Pso), ulcerative colitis (UC) and offers potential in other IL-23-mediated diseases.24,25 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.26,27 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.28
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 commercialise compounds derived from the research conducted pursuant to the agreement against a broad range of indications.29,30,31
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.3,15,16,32
ABOUT STELARA® (ustekinumab)
Ustekinumab is a fully human monoclonal antibody and is the first biologic treatment to selectively inhibit the IL-12 and IL-23 pathways.33,34 In the EU, ustekinumab is approved for the treatment of adult patients with moderate to severe Crohn’s Disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist.33 Ustekinumab is also approved for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a biologic.33 In addition to CD and UC, ustekinumab has been approved for the treatment of two further immune-mediated conditions in the EU: plaque psoriasis (Pso) and psoriatic arthritis (PsA).33
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.
Learn more at https://www.jnj.com/innovativemedicine/emea/ Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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September 2025
Media contact:
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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 #XX) at the European Academy of Dermatology and Venereology Congress (EADV). September 2025.
3 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. Available at:
https://clinicaltrials.gov/study/NCT06934226?term=iconic-ascend&rank=1. Accessed September 2025.
4 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.
5 Gooderham, M et al. Treatment of Plaque Psoriasis Involving High-Impact Areas with Icotrokinra, a Targeted Oral Peptide That Selectively Binds the Interleukin-23–Receptor: Results Through Week 16 of the Phase 3, Randomised, Double-blind, Placebo-Controlled ICONIC-TOTAL Trial. Late-breaking research presentation (Abstract #XX) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.
6 Health Research Authority. A Phase 3 Multicentre, Randomised, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis - ICONIC-ADVANCE 1. EudraCT number: 2023-505121-14. Available at:
https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/77242113pso3002-study-comparing-different-treatments-in-moderate-to-severe-plaque-psoriasis/. Accessed September 2025.
7 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Available at:
https://clinicaltrials.gov/study/NCT06220604. Accessed September 2025.
8 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 September 2025.
9 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at:
https://www.everydayhealth.com/psoriasis/living-with/how-the-pasi-index-works. Accessed September 2025.
10 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 September 2025
11 Clinicatrials.Eu. Study on the Effectiveness and Safety of JNJ-77242113 for Treating Moderate to Severe Plaque Psoriasis in Adults. EudraCT number: 2023-505120-59-00. Available at:
https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-jnj-77242113-for-treating-moderate-to-severe-plaque-psoriasis-in-adults/. Accessed September 2025.
12 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. Available at:
https://classic.clinicaltrials.gov/ct2/show/NCT06095102. Accessed September 2025.
13 Health Research Authority. A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas. EudraCT number: 2023-505122-34. Available at:
https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/77242113pso3003-study-of-treatment-for-plaque-psoriasis-involving-special-areas-iconic-total/. Accessed September 2025.
14 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 September 2025.
15 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. Available at:
https://clinicaltrials.gov/study/NCT06878404. Accessed September 2025.
16 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. Available at:
https://clinicaltrials.gov/study/NCT06807424. Accessed September 2025.
17 National Psoriasis Foundation. About Psoriasis. Available at:
https://www.psoriasis.org/about-psoriasis. Accessed September 2025.
18 University College Dublin. HPOS: UCD study recruits thousands with aim of predicting cases of psoriatic arthritis. Available at:
https://www.ucd.ie/newsandopinion/news/2023/october/26/hposucdstudyrecruitsthousandswithaimofpredictingcasesofpsoriaticarthritis. Accessed September 2025.
19 National Psoriasis Foundation. Psoriasis Statistics. Available at:
https://www.psoriasis.org/content/statistics. Accessed September 2025.
20 National Psoriasis Foundation. Plaque Psoriasis. Available at:
https://www.psoriasis.org/plaque/. Accessed September 2025.
21 National Psoriasis Foundation. Life with Psoriasis. Available at:
https://www.psoriasis.org/life-with-psoriasis/. Accessed September 2025.
22 National Psoriasis Foundation. High Impact Sites. Available at:
https://www.psoriasis.org/high-impact-sites/. Accessed September 2025.
23 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study
24 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.
25 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
26 Fourie A, et al. JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans. Sci Rep. 2024; 14(1), 17515.
https://doi.org/10.1038/s41598-024-67371-5. Accessed September 2025.
27 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.
28 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 September 2025.
29 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 September 2025.
30 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 September 2025.
31 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 September 2025.
32 ClinicalTrials.gov.NCT06049017 (ANTHEM-UC) A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Available at:
https://clinicaltrials.gov/study/NCT06049017. Accessed September 2025.
33 European Medicines Agency. Updated STELARA Summary of Product Characteristics. Available at:
Stelara, INN-ustekinumab. Accessed September 2025.
34 Benson, JM, et al. Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. MAbs. 2011 3(6):535-545.