Beerse, Belgium (March 30, 2026) – Johnson & Johnson today announced new long-term 52-week data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies, which assessed the efficacy and safety of ICOTYDE™ (icotrokinra), a first-in-class investigational targeted oral peptide designed to precisely block IL23R, in the treatment of patients with moderate to severe plaque psoriasis (PsO). The data are being presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting.
Icotrokinra robust efficacy reinforced by ICONIC-ADVANCE 1 and 2 findings
Icotrokinra achieved high levels of complete skin clearance up to Week 52 with no new safety signals.1
- In the icotrokinra treatment arms, rates of completely clear skin (PASI 100) increased from 41% to 49%, and 33% to 48%, from Week 24 to Week 52 in ADVANCE 1 and 2 respectively (N=311 and N=322).1,a,b
- Patients who switched from placebo to icotrokinra at Week 16 achieved similar rates of complete skin clearance by Week 52 (50% (N=141) and 43% (N=74) in ADVANCE 1 and 2, respectively) as those who were treated with icotrokinra for the full 52 weeks.1
- The icotrokinra adverse event (AE) profile through Week 52 was consistent with that observed through Weeks 16 and 24, and no new safety signal was identified through Week 52.1 Icotrokinra overall AE and infection rates were numerically lower than deucravacitinib through Week 24.1
“As the first IL-23 receptor targeted oral peptide, icotrokinra offers a combination of benefits in moderate to severe plaque psoriasis treatment,” said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health and ICONIC‑ADVANCE study investigator. “These one‑year results show how innovation is redefining care and delivering the lasting outcomes patients have been waiting for.”
ICONIC-LEAD data expands treatment options for adolescent patients
Icotrokinra demonstrated sustained skin clearance and a favourable safety profile, relative to placebo, in adolescents through Week 52 with no new safety signals identified.2,d
- Nearly 60% of adolescents treated with icotrokinra (N=44) achieved completely clear skin (57% PASI 100, 61% IGA 0) at Week 52.2
- In adolescents enrolled in ICONIC-LEAD and treated with icotrokinra (N=44), 86% achieved PASI 90 response at one year, with 92% maintaining that response from Week 24 to Week 52 (N=39).2
- AE incidence rates (per 100 patient years) for adolescents treated with icotrokinra were 238 (versus placebo, 521) at Week 16, with no increase through Week 52 (157 versus 182, respectively).2 In adolescents enrolled in ICONIC-LEAD through Week 52 (N=66), the most commonly observed AE was infection, occurring in 47% of patients.2
- Additional Week 52 data from ICONIC-LEAD were previously presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress.
“For the first time, patients 12 and older could have access to a novel therapy capable of delivering sustained skin clearance and an acceptable safety profile in a once-daily pill,” said Jennifer Soung, M.D., Director of Clinical Research at Southern California Dermatology and ICONIC‑LEAD study investigator. “Icotrokinra has the potential to become a transformative advance in plaque psoriasis treatment and expands what’s possible for this age group.”
“The icotrokinra one year data highlight the impact of targeted science in addressing real-world patient needs,” said Liza O’Dowd, M.D., Vice President, Immunodermatology and Respiratory Disease Areas Lead, Johnson & Johnson. “Across age groups, high‑impact disease sites, and in head‑to‑head trials, the results point to a new systemic therapy that can move the needle on treatment gaps in plaque psoriasis.”
Expert Insights
Dr Matthias Hoffmann,
Medical Doctor and Principal Investigator for the ICONIC ADVANCE 1 & 2 trials discusses this latest data.
Mark Graham,
EMEA Therapeutic Area Head, Immunology, discusses the psoriasis treatment landscape and Johnson & Johnson’s commitment to dermatology.
Editor’s Notes:
a. ICONIC-ADVANCE 1 & 2 are Phase 3 randomised controlled 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.1,3,4,5,6
b. 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 100 corresponds to an improvement of >=100% in PASI score from baseline.7
c. Drs. Soung and Stein Gold are paid consultants for Johnson & Johnson. They have not been compensated for any media work.
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 PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints.8,9,10 ICONIC-LEAD enrolled 66 adolescent patients.2
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 & Johnson company.11
- ICONIC-LEAD (EUCT: 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.8,9
- ICONIC-TOTAL (EUCT: 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
- ICONIC-ADVANCE 1 (EUCT:2023-505121-14; NCT06143878) and ICONIC-ADVANCE 2 (EUCT: 2023-507039-39-00) (NCT06220604), are RCTs to evaluate the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque Pso.3,4,5,6
- ICONIC-ASCEND (EUCT: 2024-515706-77-00) (NCT06934226) is an RCT to evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis.14,15
ICONIC-PsA 1 (EUCT: 2023-509239-19-00) (NCT06878404) and ICONIC-PsA 2 (EUCT: 2024-517284-23-00) (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis; ICONIC-UC (EUCT: 2025-521381-10-00) (NCT071196748) in moderately to severely active ulcerative colitis; and ICONIC-CD (EUCT: 2025-521382-27-00) (NCT7196722) in moderately to severely active Crohn’s disease.16,17,18,19,20,21,22,23
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.24 It is estimated that 6.4 million people in Europe and more than 125 million people worldwide live with the disease.25,26 Nearly one-quarter of all people with plaque Pso have cases that are considered moderate-to-severe.26 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales.27 Plaques may appear red in lighter skin or more of a purple, grey or dark brown colour in patients with darker skin tones.27 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.27 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.27 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. 28,29
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first-in-class targeted oral peptide designed to precisely block the IL-23 receptor30, which underpins the inflammatory response in moderate-to-severe Pso, ulcerative colitis (UC) and offers potential in other IL-23-mediated diseases.31,32 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells.33,34 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.35
Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson.35 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.36,37,38
Icotrokinra is also being studied the Phase 2b ANTHEM-UC (EUCT: 2023-504673-20-00) study in moderately to severely active ulcerative colitis.39
ABOUT JOHNSON & JOHNSON
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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.
Media contact:
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Lpeeter8@its.jnj.com
Investor contact:
Lauren Johnson
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CP-572937
March 2026
1 J&J Data on file (RF-501224). Stein Gold L. et al. Durability of response with icotrokinra, a targeted oral peptide, in adults with moderate-to-severe plaque psoriasis: One-year results from the Phase 3, placebo- and active comparator-controlled ICONIC-ADVANCE 1 & ICONIC ADVANCE 2 trials. Accessed March 2026.
2 J&J Data on file (RF-501231). Soung J. et al. Durability of icotrokinra (targeted oral peptide) effects in adolescents with moderate-to-severe plaque psoriasis: One-year results from the ICONIC-LEAD study. European Medicines Agency. Updated TREMFYA Summary of Product Characteristics. Accessed April 2025.
3 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. EUCT 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. Euclinicaltrials.eu.
4 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 March 2026.
5 A Phase 3 Multicenter, Randomized, 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. EUCT number: 2023-507039-39-00. Available at: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-507039-39-00. Accessed March 2026.
6 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.
7 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 March 2025.
8 EUclinicatrials.eu. Study on the Effectiveness and Safety of JNJ-77242113 for Treating Moderate to Severe Plaque Psoriasis in Adults. EUCT 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 March 2026.
9 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 March 2026.
10 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
11 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 March 2026.
12 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. EUCT 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.
13 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 March 2026.
14 EUclinicaltrials.eu. Study on the Effectiveness and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab for Patients with Moderate to Severe Plaque Psoriasis. EUCT number: 2024-515706-77-00. Available at: https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-jnj-77242113-compared-to-placebo-and-ustekinumab-for-patients-with-moderate-to-severe-plaque-psoriasis/. Accessed March 2026.
15 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 NCT06934226. Available at: https://clinicaltrials.gov/study/NCT06934226?term=iconic-ascend&rank=1. Accessed September 2025.
16 EUclinicaltrials.eu. A Study of the Efficacy and Safety of JNJ-77242113 in Biologic-naïve Participants with Active Psoriatic Arthritis. EUCT number: 2023-509239-19-00. Available at: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-509239-19-00. Accessed March 2026.
17 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 March 2026.
18 EUclinicaltrials.eu. A Study of the Efficacy and Safety of JNJ-77242113 in Biologic-experienced Participants with Active Psoriatic Arthritis. EUCT number: 2024-517284-23-00. Available at: https://euclinicaltrials.eu/ctis-public/view/2024-517284-23-00?lang=en. Accessed March 2026.
19 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 March 2026.
20 EUclinicaltrials.eu. Efficacy and Safety of Icotrokinra in Adult and Adolescent Participants with Moderately to Severely Active Ulcerative Colitis. EUCT number: 2025-521381-10-00. Available at: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-521381-10-00. Accessed March 2026.
21 Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. https://clinicaltrials.gov/study/NCT07196748. Accessed March 2026.
22 EUclinicaltrials.eu. Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s Disease. EUCT number: 2025-521382-27-00. Available at: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-521382-27-00. Accessed March 2026.
23 Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn’s Disease (ICONIC-CD). Identifier NCT07196722. https://clinicaltrials.gov/study/NCT07196722. Accessed March 2026.
24 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed March 2026.
25 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 March 2026.
26 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed March 2026.
27 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/. Accessed March 2026.
28 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed March 2026.
29 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed March 2026.
30 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.
31 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.
32 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
33 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 March 2026.
34 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.
35 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 March 2026.
36 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 March 2026.
37 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 March 2026.
38 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 March 2026.
39 EUclinicaltrials.gov. A Phase 2b Multicenter, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis. EUCT number: 2023-504673-20-00. Available at: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-504673-20-00. Accessed March 2026.