Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill
Johnson & Johnson (NYSE: JNJ) reported Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra, a once-daily oral peptide that selectively blocks the IL-23 receptor. The study met its primary endpoint with clinical response rates of 63.5% at 400 mg versus 27% for placebo (p<0.001); 200 mg and 100 mg showed 58.1% and 54.7% response rates. At Week 12 the 400 mg group achieved clinical remission 30.2% (p=0.006), symptomatic remission 46.0%, and endoscopic improvement 36.5% (p=0.002). Safety profiles and serious adverse event rates were similar to placebo through Week 12. Based on these data JNJ has initiated Phase 3 ICONIC-UC and ICONIC-CD programs and submitted an NDA in July 2025 for icotrokinra in plaque psoriasis.
Johnson & Johnson (NYSE: JNJ) ha riportato i risultati della Settimana 12 dello studio di fase 2b ANTHEM-UC su icotrokinra, una peptidica orale assunta una volta al giorno che blocca selettivamente il recettore IL-23. Lo studio ha raggiunto l'obiettivo primario con tassi di risposta clinica del 63,5% a 400 mg rispetto al 27% del placebo (p<0,001); 200 mg e 100 mg hanno mostrato tassi di risposta del 58,1% e 54,7%. Alla Settimana 12 il gruppo 400 mg ha ottenuto remissione clinica 30,2% (p=0,006), remissione sintomatica 46,0% e miglioramento endoscopico 36,5% (p=0,002). I profili di sicurezza e i tassi di eventi avversi gravi sono stati simili al placebo fino alla Settimana 12. Sulla base di questi dati JNJ ha avviato i programmi di Fase 3 ICONIC-UC e ICONIC-CD e ha presentato una NDA nel luglio 2025 per icotrokinra nella psoriasi a placche.
Johnson & Johnson (NYSE: JNJ) informó resultados de la Semana 12 del estudio de fase 2b ANTHEM-UC de icotrokinra, una peptídico oral de una dosis diaria que bloquea selectivamente el receptor IL-23. El estudio cumplió el objetivo primario con tasas de respuesta clínica del 63,5% a 400 mg frente al 27% con placebo (p<0,001); 200 mg y 100 mg mostraron tasas de respuesta del 58,1% y 54,7%. En la Semana 12, el grupo de 400 mg logró remisión clínica del 30,2% (p=0,006), remisión sintomática 46,0% y mejora endoscópica 36,5% (p=0,002). Los perfiles de seguridad y las tasas de eventos adversos graves fueron similares al placebo hasta la Semana 12. Con base en estos datos, JNJ ha iniciado los programas de Fase 3 ICONIC-UC e ICONIC-CD y presentó una NDA en julio de 2025 para icotrokinra en la psoriasis en placas.
Johnson & Johnson (NYSE: JNJ)은 icotrokinra의 위크 12 주 결과를 발표했습니다. 이는 IL-23 수용체를 선택적으로 차단하는 하루에 한 번 복용하는 경구 펩타이드입니다. 연구는 주요 평가변수를 충족했으며 400 mg에서 임상 반응률이 63.5%로 위약 27% 대비(p<0.001); 200 mg 및 100 mg는 각각 58.1%, 54.7%의 반응률을 보였습니다. Week 12에서 400 mg 그룹은 임상 관해 30.2% (p=0.006), 증상 관해 46.0%, 내시경적 개선 36.5% (p=0.002)를 달성했습니다. 안전성 프로파일과 심각한 이상반응 비율은 Week 12까지 위약과 비슷했습니다. 이러한 데이터를 바탕으로 JNJ는 Phase 3 ICONIC-UC 및 ICONIC-CD 프로그램을 시작했고, 2025년 7월에 플라크성 건선에 대해 icotrokinra의 NDA를 제출했습니다.
Johnson & Johnson (NYSE : JNJ) a communiqué les résultats de la Semaine 12 de l'étude de phase 2b ANTHEM-UC d'icotrokinra, une peptide orale administrée une fois par jour qui bloque sélectivement le récepteur IL-23. L'étude a atteint son objectif primaire avec des taux de réponse clinique de 63,5% à 400 mg contre 27% pour le placebo (p<0,001); 200 mg et 100 mg ont montré des taux de réponse de 58,1% et 54,7%. À la Semaine 12, le groupe 400 mg a atteint une rémission clinique de 30,2% (p=0,006), une rémission symptomatique de 46,0% et une amélioration endoscopique de 36,5% (p=0,002). Les profils de sécurité et les taux d'événements indésirables graves étaient similaires au placebo jusqu'à la Semaine 12. Sur la base de ces données, JNJ a lancé les programmes de phase 3 ICONIC-UC et ICONIC-CD et a déposé une NDA en juillet 2025 pour l'icotrokinra dans le psoriasis en plaques.
Johnson & Johnson (NYSE: JNJ) hat die Ergebnisse der Woche 12 der Phase-2b-Studie ANTHEM-UC von Icotrokinra gemeldet, einem einmal täglich einzunehmenden oralen Peptid, das den IL-23-Rezeptor selektiv blockiert. Die Studie erreichte den primären Endpunkt mit klinischen Ansprechraten von 63,5% bei 400 mg gegenüber 27% Placebo (p<0,001); 200 mg und 100 mg zeigten 58,1% bzw. 54,7%. In Woche 12 erreichte die 400-mg-Gruppe klinische Remission von 30,2% (p=0,006), symptomatische Remission 46,0% und endoskopische Verbesserung 36,5% (p=0,002). Sicherheitsprofile und Raten schwerer unerwünschter Ereignisse waren bis Woche 12 ähnlich wie Placebo. Basierend auf diesen Daten hat JNJ Phase-3-Programme ICONIC-UC und ICONIC-CD eingeleitet und im Juli 2025 eine NDA für Icotrokinra bei Plaque-Psoriasis eingereicht.
Johnson & Johnson (NYSE: JNJ) أعلنت نتائج الأسبوع 12 من دراسة المرحلة 2b ANTHEM-UC لـ icotrokinra، وهو ببتيد فموي يتم تناوله مرة واحدة يوميًا ويعمل على حجب مستقبل IL-23 بشكل انتقائي. أظهرت الدراسة استيفاء الهدف الأساسي بمعدلات استجابة سريرية تبلغ 63.5% عند 400 mg مقابل 27% للدواء الوهمي (p<0,001)؛ وظهر لدى 200 mg و100 mg معدل استجابة قدره 58.1% و54.7%. في الأسبوع 12، حقق مجموعة 400 mg إحالة سريرية بنسبة 30.2% (p=0.006)، وإحالة عرضية 46.0%، وتحسناً منظارياً 36.5% (p=0.002). كانت ملفات السلامة ومعدلات الأحداث الضارة الخطيرة متماثلة مع placebo حتى الأسبوع 12. وبناءً على هذه البيانات، بدأت JNJ برامج المرحلة 3 ICONIC-UC وICONIC-CD وقدمت NDA في يوليو 2025 لـ icotrokinra لعلاج الصدفية اللويحية.
强生公司 (NYSE: JNJ) 报告了 ANTHEM-UC 2b 期研究的 Week 12 结果，关于 icotrokinra，一种每日口服肽药物，选择性阻断 IL-23 受体。研究达到主要终点，400 mg 组临床应答率为 63.5%，对比安慰剂 27%（p<0.001）；200 mg 和 100 mg 的应答率分别为 58.1% 和 54.7%。Week 12 时，400 mg 组实现临床缓解 30.2%（p=0.006），症状缓解 46.0%，内镜改善 36.5%（p=0.002）。安全性谱和严重不良事件率在 Week 12 前后与安慰剂相似。基于这些数据，JNJ 已启动 Phase 3 ICONIC-UC 与 ICONIC-CD 计划，并于 2025 年 7 月就 icotrokinra 在斑块型银屑病提交了 NDA。
- Primary endpoint met: clinical response at Week 12 across all doses
- Icotrokinra 400 mg: clinical response 63.5% versus placebo 27% (p<0.001)
- 400 mg endoscopic improvement 36.5% at Week 12 (p=0.002)
- 400 mg clinical remission 30.2% at Week 12 (p=0.006)
- Safety profile through Week 12 similar to placebo
- Phase 3 ICONIC-UC and ICONIC-CD programs initiated; NDA submitted July 2025
- 100 mg clinical remission non-significant (21.9% p=0.092)
- 100 mg endoscopic improvement non-significant (26.6% p=0.072)
- 200 mg clinical remission borderline (24.2% p=0.054) indicating mixed dose-response
Insights
Icotrokinra met Phase 2b endpoints in UC with clear dose response and no excess early safety signal.
The drug produced a clinical response of
These facts point to a Phase
Icotrokinra met the primary endpoint of clinical response at all three doses, with
These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis
At Week 12, patients treated with 400 mg of icotrokinra once-daily achieved a clinical response rate of
Across multiple secondary endpoints, in the 400 mg icotrokinra group, significantly greater proportions of patients achieved clinical remission, symptomatic remission and endoscopic improvement at Week 12 compared to placebo. Both the 200 mg and 100 mg once-daily dosing groups also showed meaningful improvements in these secondary endpoints relative to placebo. All icotrokinra doses demonstrated higher rates of symptomatic remission compared to placebo as early as Week 4.1
|
At Week 12: |
Icotrokinra 400 mg |
Icotrokinra 200 mg |
Icotrokinra 100 mg |
Placebo |
|
Clinical remissionb |
p=0.006 |
p=0.054 |
p=0.092 |
11.1 % |
|
Symptomatic remissionc |
p<0.001 |
p=0.005 |
p<0.001 |
19 % |
|
Endoscopic improvementd |
p=0.002 |
p=0.007 |
p=0.072 |
14.3 % |
Similar proportions of participants reported adverse events and serious adverse events through Week 12 across all icotrokinra dose groups and the placebo group.1
"Ulcerative colitis can bring unpredictable and often debilitating symptoms that make even simple daily activities a challenge for many patients," said Maria T. Abreu, M.D., Executive Director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai in
Based on results from the Phase 2b ANTHEM-UC study, Johnson & Johnson has initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderately to severely active Crohn's disease.2,3 Icotrokinra is also being studied in the pivotal Phase 3 ICONIC program in moderate-to-severe plaque psoriasis and the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis. A New Drug Application (NDA) was submitted to the
"Icotrokinra marks the next chapter in our history of innovation in inflammatory bowel disease, building on our deep scientific expertise in the IL-23 pathway to develop targeted solutions that address the complexity of disease biology and meet the real-world needs of patients," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "We look forward to initiating our Phase 3 investigation of icotrokinra in UC, with the aim of delivering meaningful improvements to patients living with this debilitating disease."
Editor's notes:
a. Clinical response was defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
b. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0 or 1.
c. Symptomatic remission per Mayo score was defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
d. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1.
e. Dr. Abreu is a paid consultant for Johnson & Johnson. She has not been compensated for any media work.
About ANTHEM-UC
ANTHEM-UC (NCT06049017) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally.4
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.5
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,6 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.7,8 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.9 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.10
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.11,12,13
Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis; 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.
Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.
Follow us at @JNJInnovMed.
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 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.
References:
1 Abreu M., et al. Icotrokinra, a targeted oral peptide that selectively blocks IL-23 receptor activation, in moderately to severely active ulcerative colitis: week 12 results from the phase 2b, randomized, double-blind, placebo-controlled, treat-through, dose-ranging ANTHEMUC trial. Oral presentation OP206 at United European Gastroenterology Week (UEGW) 2025. October 2025.
2 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 October 2025.
3 Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease. Identifier NCT07196722. https://clinicaltrials.gov/study/NCT07196722. Accessed October 2025.
4 Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1. Accessed February 2025.
5 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed April 2024.
6 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.
7 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.
8 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
9 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.
10 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 November 2024.
11 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 November 2024.
12 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 November 2024.
13 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 November 2024.
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FAQ
What were the ANTHEM-UC Week 12 clinical response rates for icotrokinra (JNJ)?
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