Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill
Johnson & Johnson (NYSE: JNJ) announced promising Phase 3 trial results for icotrokinra (JNJ-2113), a first-in-class investigational oral peptide for moderate-to-severe plaque psoriasis. The ICONIC-LEAD study, the first to simultaneously assess a systemic therapy in both adolescents and adults, showed remarkable efficacy in adolescent patients.
Key findings at Week 16 showed 84.1% of adolescent patients achieved clear or almost clear skin (IGA 0/1), compared to 27.3% for placebo. By Week 24, results improved further with 86.4% achieving IGA 0/1, and notably, 75% achieving completely clear skin (IGA 0).
The drug demonstrated a favorable safety profile, with 50% of adolescents experiencing ≥1 adverse event compared to 73% in the placebo group. The study involved 684 participants, including 66 adolescents, marking a significant advancement in psoriasis treatment options for younger patients.
Johnson & Johnson (NYSE: JNJ) ha annunciato risultati promettenti della fase 3 per icotrokinra (JNJ-2113), un peptide orale sperimentale di prima classe per la psoriasi a placche da moderata a grave. Lo studio ICONIC-LEAD, il primo a valutare simultaneamente una terapia sistemica sia negli adolescenti che negli adulti, ha mostrato un'efficacia notevole nei pazienti adolescenti.
I principali risultati alla settimana 16 hanno mostrato che l'84,1% dei pazienti adolescenti ha raggiunto una pelle chiara o quasi chiara (IGA 0/1), rispetto al 27,3% del gruppo placebo. Alla settimana 24, i risultati sono ulteriormente migliorati, con l'86,4% che ha raggiunto IGA 0/1 e, in particolare, il 75% ha ottenuto una pelle completamente chiara (IGA 0).
Il farmaco ha dimostrato un profilo di sicurezza favorevole, con il 50% degli adolescenti che ha sperimentato ≥1 evento avverso rispetto al 73% nel gruppo placebo. Lo studio ha coinvolto 684 partecipanti, di cui 66 adolescenti, segnando un significativo progresso nelle opzioni di trattamento per la psoriasi nei pazienti più giovani.
Johnson & Johnson (NYSE: JNJ) anunció resultados prometedores de un ensayo de fase 3 para icotrokinra (JNJ-2113), un péptido oral en investigación de primera clase para la psoriasis en placas de moderada a grave. El estudio ICONIC-LEAD, el primero en evaluar simultáneamente una terapia sistémica en adolescentes y adultos, mostró una eficacia notable en pacientes adolescentes.
Los hallazgos clave a las 16 semanas mostraron que el 84,1% de los pacientes adolescentes lograron una piel clara o casi clara (IGA 0/1), en comparación con el 27,3% del grupo placebo. A las 24 semanas, los resultados mejoraron aún más, con el 86,4% logrando IGA 0/1 y, notablemente, el 75% alcanzando una piel completamente clara (IGA 0).
El medicamento demostró un perfil de seguridad favorable, con el 50% de los adolescentes experimentando ≥1 evento adverso en comparación con el 73% en el grupo placebo. El estudio incluyó a 684 participantes, de los cuales 66 eran adolescentes, marcando un avance significativo en las opciones de tratamiento para la psoriasis en pacientes más jóvenes.
존슨 & 존슨 (NYSE: JNJ)은 중등도에서 중증의 판상 건선 치료를 위한 최초의 경구 펩타이드인 이코트로킨라(JNJ-2113)의 3상 시험에서 유망한 결과를 발표했습니다. ICONIC-LEAD 연구는 청소년과 성인 모두에서 체계적인 치료를 동시에 평가한 첫 연구로, 청소년 환자에서 주목할 만한 효능을 보여주었습니다.
16주 차 주요 결과에 따르면 84.1%의 청소년 환자가 깨끗하거나 거의 깨끗한 피부(IGA 0/1)를 달성했으며, 이는 위약군의 27.3%와 비교됩니다. 24주 차에는 결과가 더욱 개선되어 86.4%가 IGA 0/1을 달성했으며, 특히 75%가 완전히 깨끗한 피부(IGA 0)를 달성했습니다.
이 약물은 50%의 청소년이 ≥1개의 부작용을 경험한 반면, 위약군에서는 73%가 부작용을 경험하여 안전성 프로필이 유리함을 보여주었습니다. 이 연구에는 684명의 참가자가 포함되었으며, 이 중 66명이 청소년으로, 젊은 환자들을 위한 건선 치료 옵션에서 중요한 발전을 나타냅니다.
Johnson & Johnson (NYSE: JNJ) a annoncé des résultats prometteurs d'un essai de phase 3 pour l'icotrokinra (JNJ-2113), un peptide oral expérimental de première classe pour la psoriasis en plaques modéré à sévère. L'étude ICONIC-LEAD, la première à évaluer simultanément une thérapie systémique chez les adolescents et les adultes, a montré une efficacité remarquable chez les patients adolescents.
Les résultats clés à la semaine 16 ont montré que 84,1% des patients adolescents avaient atteint une peau claire ou presque claire (IGA 0/1), contre 27,3% pour le placebo. À la semaine 24, les résultats se sont encore améliorés avec 86,4% atteignant l'IGA 0/1, et notons que 75% ont atteint une peau complètement claire (IGA 0).
Le médicament a démontré un profil de sécurité favorable, avec 50% des adolescents ayant subi ≥1 événement indésirable contre 73% dans le groupe placebo. L'étude a impliqué 684 participants, dont 66 adolescents, marquant un progrès significatif dans les options de traitement de la psoriasis pour les jeunes patients.
Johnson & Johnson (NYSE: JNJ) hat vielversprechende Ergebnisse der Phase-3-Studie für Icotrokinra (JNJ-2113) bekannt gegeben, ein neuartiges orales Peptid zur Behandlung von moderater bis schwerer Plaque-Psoriasis. Die ICONIC-LEAD-Studie, die erste, die eine systemische Therapie sowohl bei Jugendlichen als auch bei Erwachsenen gleichzeitig bewertet, zeigte bemerkenswerte Wirksamkeit bei jugendlichen Patienten.
Wichtige Ergebnisse in der Woche 16 zeigten, dass 84,1% der jugendlichen Patienten eine klare oder nahezu klare Haut (IGA 0/1) erreichten, verglichen mit 27,3% in der Placebo-Gruppe. In Woche 24 verbesserten sich die Ergebnisse weiter, wobei 86,4% IGA 0/1 erreichten und bemerkenswerterweise 75% eine völlig klare Haut (IGA 0) erreichten.
Das Medikament zeigte ein günstiges Sicherheitsprofil, da 50% der Jugendlichen ≥1 unerwünschte Ereignis erlebten, während es in der Placebo-Gruppe 73% waren. An der Studie nahmen 684 Teilnehmer teil, darunter 66 Jugendliche, was einen bedeutenden Fortschritt bei den Behandlungsmöglichkeiten für Psoriasis bei jüngeren Patienten darstellt.
- High efficacy rates with 84.1% achieving clear/almost clear skin at Week 16
- Superior safety profile compared to placebo (50% vs 73% adverse events)
- First-in-class oral treatment showing promising results for adolescents
- Continued improvement in efficacy through Week 24 (75% achieving completely clear skin)
- None.
Insights
The Phase 3 ICONIC-LEAD results for icotrokinra represent a potentially significant advancement in J&J's immunodermatology portfolio. The data showing
What makes icotrokinra particularly noteworthy is its novel mechanism as a first-in-class oral peptide targeting the IL-23 receptor pathway. This differentiates it from J&J's existing injectable IL-23 inhibitor Tremfya (guselkumab) and provides a strategic complement rather than a cannibalization risk. The once-daily oral administration addresses a significant unmet need, as current IL-23 inhibitors require injections, creating a meaningful advantage for patient convenience and compliance—especially critical in the adolescent population.
The favorable safety profile, with fewer adverse events than placebo (
This development strengthens J&J's competitive position against emerging oral psoriasis treatments like BMS's deucravacitinib, while offering a potentially preferable safety profile compared to JAK inhibitors. The impressive clearance rates position icotrokinra as a potential first-line systemic therapy that could expand the treatable market beyond current biologic users.
These ICONIC-LEAD results represent a clinically meaningful advancement for adolescent psoriasis treatment. The
The simultaneous enrollment of adolescents and adults in this Phase 3 trial reflects an important evolution in dermatology research, potentially accelerating pediatric access to advanced therapies. Adolescents with moderate-to-severe psoriasis currently have FDA-approved systemic options compared to adults, making this development particularly significant.
From a mechanism perspective, selectively targeting the IL-23 receptor through an oral peptide represents a novel approach. Current IL-23 inhibitors are monoclonal antibodies requiring injection, which can present adherence challenges, especially in younger populations. The favorable safety profile—with lower adverse event rates than placebo—is particularly noteworthy as safety concerns often limit systemic therapy use in adolescents.
The oral administration route eliminates injection-related barriers while potentially offering efficacy comparable to biologics—addressing a critical treatment gap. If approved, icotrokinra would provide dermatologists a compelling first-line systemic option for adolescents with moderate-to-severe disease who often struggle with the psychological and social impacts of visible skin disease during a vulnerable developmental period.
ICONIC-LEAD is the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis to assess safety and efficacy of a systemic therapy in adolescents and adults simultaneously
In the study,
Response rates continued to improve through Week 24 where
"Data from the Phase 3 ICONIC LEAD subgroup analysis demonstrate impressive efficacy rates, showing the promise of this novel therapeutic option in the treatment of adolescents with moderate-to-severe plaque psoriasis who've often not yet received an advanced therapy," said Lawrence Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, and Professor of Pediatrics and Medicine (Dermatology), at the University of
Icotrokinra demonstrated a favorable safety profile. At Week 16,
"Adolescents living with moderate to severe plaque psoriasis shouldn't have to wait for effective treatments options that have the potential to deliver completely clear skin, which is the driving force for studying this younger population as part of the pivotal ICONIC program," said Liza O'Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. "These data underscore the promise of next-generation therapies and the potential for icotrokinra to offer adolescents with moderate-to-severe plaque psoriasis the unique combination of a favorable safety profile and complete skin clearance in a once-daily pill."
Editor's notes:
a. 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.
b. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease.2
c. 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.3 PASI 90 corresponds to an improvement of >=
d. Dr. Lawrence Eichenfield is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
About the ICONIC Clinical Development Program
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.4
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.5
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.6
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.7,8 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. will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.
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.9 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.10 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.11 On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale.11 On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color.12 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.12 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.12 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.12,13
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,14 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.15,16 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.17 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.18
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.19,20,21
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.
Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or 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. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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1 Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025. |
2 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.04.104. Accessed April 2025. |
3 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 April 2025. |
4 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 April 2025. |
5 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 April 2025. |
6 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 April 2025. |
7 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 April 2025. |
8 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 April 2025. |
9 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed April 2025. |
10 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed April 2025. |
11 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed April 2025. |
12 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed April 2025. |
13 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed April 2025. |
14 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. |
15 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. |
16 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. |
17 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. |
18 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 April 2025. |
19 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 April 2025. |
20 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 April 2025. |
21 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 April 2025. |
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FAQ
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