Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis
Rhea-AI Summary
Johnson & Johnson (NYSE: JNJ) reported Week 28 Phase 2b ANTHEM-UC results for icotrokinra in moderately to severely active ulcerative colitis on Oct 27, 2025.
Key outcomes at Week 28 for the 400 mg once-daily dose: clinical remission 31.7% vs placebo 9.5%, endoscopic improvement 38.1% vs placebo 11.1%, and clinical response 66.7% vs placebo 25.4%. All tested doses (100 mg, 200 mg, 400 mg) favored icotrokinra over placebo for response, remission, endoscopic and histologic-endoscopic mucosal improvement.
Adverse event and serious adverse event rates were reported as similar across icotrokinra and placebo through Week 28. Phase 3 programs (ICONIC-UC and ICONIC-CD) are underway; an NDA for plaque psoriasis was submitted in July 2025.
Positive
- Clinical remission 31.7% at Week 28 versus placebo 9.5%
- Endoscopic improvement 38.1% at Week 28 versus placebo 11.1%
- Clinical response 66.7% at Week 28 versus placebo 25.4%
- Sustained efficacy through Week 28 across all tested doses
- Adverse and serious adverse event rates similar to placebo through Week 28
Negative
- Evidence limited to Phase 2b; Phase 3 outcomes not yet available
- No regulatory approval reported for ulcerative colitis to date
News Market Reaction – JNJ
On the day this news was published, JNJ declined 0.05%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with
Results support Phase 3 clinical development of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in both moderately to severely active ulcerative colitis and Crohn's disease
At Week 28, icotrokinra demonstrated sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical responsea, clinical remissionb, endoscopic improvementc and histologic-endoscopic mucosal improvement (HEMI)d at Week 28 compared to placebo.1 These outcomes build on Week 12 data recently presented at United European Gastroenterology (UEG) Week 2025 where all doses of icotrokinra demonstrated superiority to placebo for the primary endpoint of clinical response.2
|
Icotrokinra 400 mg once daily |
Week 12 |
Week 28 |
Placebo (at Week 28) |
|
Clinical response1 |
63.5 % |
66.7 % |
25.4 % |
|
Clinical remission1 |
30.2 % |
31.7 % |
9.5 % |
|
Endoscopic improvement1 |
36.5 % |
38.1 % |
11.1 % |
|
HEMI rates1 |
28.6 % |
33.1 % |
11.1 % |
"The ANTHEM-UC results show that targeting the IL-23 pathway with a once-daily oral therapy can provide meaningful, sustained benefit and a favorable safety profile, giving healthcare providers a potential new approach to managing this challenging disease," said Vipul Jairath, MBChB, DPhil, Professor of Medicine at Western University in
Similar proportions of participants reported adverse events and serious adverse events through Week 28 across all icotrokinra dose groups and the placebo group.1
"These exciting results show how we are harnessing our deep understanding of the IL-23 pathway to advance innovative treatments for inflammatory bowel disease that address the daily needs of patients," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "With Phase 3 development now underway in both adult and adolescent patients, our aim is to establish icotrokinra as a promising therapy that could transform the treatment paradigm in ulcerative colitis and bring patients a potential new option."
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 moderate to severely active Crohn's disease. 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
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 stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
c. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1.
d. Histologic-endoscopic mucosal improvement (HEMI) was defined as histologic remission (absence of neutrophils from the mucosa in both lamina propria and epithelium, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement (MES of 0 or 1).
e. Dr. Jairath is a paid consultant for Johnson & Johnson. He 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. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.3
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.4
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor,5 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.6,7 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signalling in human T cells.8 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.9 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.10,11,12
Icotrokinra is being studied in the Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.
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 Jairath V., et al. Efficacy and Safety of Icotrokinra, a Targeted Oral Peptide That Selectively Blocks IL-23 Receptor Activation, In Ulcerative Colitis: Results From Week 28 of ANTHEM-UC, a Phase 2b Dose-ranging Trial. Poster 1066 at ACG Annual Scientific Meeting 2025. October 2025.
2 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.
3 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.
4 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed April 2024.
5 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.
6 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.
7 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
8 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.
9 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.
10 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.
11 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.
12 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.
|
Media contact:
|
Investor contact:
|
View original content to download multimedia:https://www.prnewswire.com/news-releases/icotrokinra-maintains-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill-through-28-weeks-in-ulcerative-colitis-302594371.html
SOURCE Johnson & Johnson
FAQ
What Week 28 results did JNJ report for icotrokinra in ulcerative colitis on Oct 27, 2025?
How did icotrokinra safety compare to placebo through Week 28 in the ANTHEM-UC study (JNJ)?
Does JNJ plan Phase 3 trials for icotrokinra in ulcerative colitis after the Oct 27, 2025 update?
What magnitude of benefit did icotrokinra show versus placebo for endoscopic improvement at Week 28 (JNJ)?
Has icotrokinra received FDA approval for ulcerative colitis as of Oct 27, 2025 (JNJ)?
