A Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of JNJ-77242113 for the treatment of biologic-experienced participants with active psoriatic arthritis

Start Date01 Mar 2025

Sponsor / Collaborator

Janssen-Cilag International NV

CTR20250028

/ RecruitingPhase 3

一项评价JNJ-77242113用于未接受过生物制剂治疗的活动性银屑病关节炎受试者的疗效和安全性的III期、多中心、随机、双盲、安慰剂对照研究

[Translation] A Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JNJ-77242113 in subjects with active psoriatic arthritis who have not received prior biologic therapy

本研究的目的是通过评估icotrokinra与安慰剂相比对活动性银屑病关节炎(PsA)受试者体征和症状减轻的疗效

[Translation]

The purpose of this study was to evaluate the efficacy of icotrokinra compared with placebo in reducing signs and symptoms in subjects with active psoriatic arthritis (PsA).

Start Date26 Feb 2025

Sponsor / Collaborator

Janssen Pharmaceutica NV

[+5]

CTR20244975

/ RecruitingPhase 3

一项评价JNJ-77242113用于接受过生物制剂治疗的活动性银屑病关节炎受试者的疗效和安全性的III期、多中心、随机、双盲、安慰剂对照研究

本研究的目的是通过评估icotrokinra与安慰剂相比对活动性银屑病关节炎(PsA)受试者体征和症状减轻的疗效

[Translation]

The purpose of this study was to evaluate the efficacy of icotrokinra compared with placebo in reducing signs and symptoms in subjects with active psoriatic arthritis (PsA).

Start Date24 Feb 2025

Sponsor / Collaborator

Johnson & Johnson (China) Investment Ltd.

[+1]

100 Clinical Results associated with Icotrokinra

100 Translational Medicine associated with Icotrokinra

100 Patents (Medical) associated with Icotrokinra

Literatures (Medical) associated with Icotrokinra

01 Mar 2025·Journal of the American Academy of Dermatology

FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis

Article

Author: Li, Shu ; Tyring, Stephen K ; Iaconangelo, Charles ; Huang, Yu-Huei ; Bissonnette, Robert ; Pink, Andrew E ; Ferris, Laura K ; Bagel, Jerry ; Kokolakis, Georgios ; Ota, Takayuki ; Shen, Yaung-Kaung ; DeLozier, Amy M

BACKGROUNDMore patients with moderate-to-severe plaque psoriasis achieved responses with JNJ-77242113, a targeted oral peptide inhibiting interleukin-23 receptor signaling, versus placebo (PBO) at week (W)16 of the phase 2 FRONTIER-1 study.OBJECTIVEFRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.METHODSFRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16-52. Safety follow-up continued through W56.RESULTSMost (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16-52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16-56, 59% of JNJ-77242113-treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.LIMITATIONSThe study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.CONCLUSIONRates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.

08 Feb 2024·New England Journal of MedicineQ1 · MEDICINE

An Oral Interleukin-23–Receptor Antagonist Peptide for Plaque Psoriasis

Q1 · MEDICINE

Article

Author: DeKlotz, Cynthia ; Rich, Phoebe ; Kannan, Arun ; Pinter, Andreas ; Bissonnette, Robert ; Papp, Kim ; Ferris, Laura K ; Shen, Yaung-Kaung ; Li, Shu ; Vender, Ronald ; Gerdes, Sascha ; Miller, Megan

BACKGROUNDThe use of monoclonal antibodies has changed the treatment of several immune-mediated inflammatory diseases, including psoriasis. However, these large proteins must be administered by injection. JNJ-77242113 is a novel, orally administered interleukin-23-receptor antagonist peptide that selectively blocks interleukin-23 signaling and downstream cytokine production.METHODSIn this phase 2 dose-finding trial, we randomly assigned patients with moderate-to-severe plaque psoriasis to receive JNJ-77242113 at a dose of 25 mg once daily, 25 mg twice daily, 50 mg once daily, 100 mg once daily, or 100 mg twice daily or placebo for 16 weeks. The primary end point was a reduction from baseline of at least 75% in the Psoriasis Area and Severity Index (PASI) score (PASI 75 response; PASI scores range from 0 to 72, with higher scores indicating greater extent or severity of psoriasis) at week 16.RESULTSA total of 255 patients underwent randomization. The mean PASI score at baseline was 19.1. The mean duration of psoriasis was 18.2 years, and 78% of the patients across all the trial groups had previously received systemic treatments. At week 16, the percentages of patients with a PASI 75 response were higher among those in the JNJ-77242113 groups (37%, 51%, 58%, 65%, and 79% in the 25-mg once-daily, 25-mg twice-daily, 50-mg once-daily, 100-mg once-daily, and 100-mg twice-daily groups, respectively) than among those in the placebo group (9%), a finding that showed a significant dose-response relationship (P<0.001). The most common adverse events included coronavirus disease 2019 (in 12% of the patients in the placebo group and in 11% of those across the JNJ-77242113 dose groups) and nasopharyngitis (in 5% and 7%, respectively). The percentages of patients who had at least one adverse event were similar in the combined JNJ-77242113 dose group (52%) and the placebo group (51%). There was no evidence of a dose-related increase in adverse events across the JNJ-77242113 dose groups.CONCLUSIONSAfter 16 weeks of once- or twice-daily oral administration, treatment with the interleukin-23-receptor antagonist peptide JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and Development; FRONTIER 1 ClinicalTrials.gov number, NCT05223868.).

Scientific Reports

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

Article

Author: Fourie, Anne M ; Towne, Jennifer ; Knight, Beverly ; Patrick, Aaron ; Sherlock, Jonathan P ; Allen, Samantha J ; Bhandari, Ashok ; Somani, Sandeep ; Chang, Leon ; Kannan, Arun ; Steele, Ruth ; Holland, M Claire ; Bains, Trpta ; Rodriguez, Michael A ; Modi, Nishit B ; Polidori, David ; Xue, Xiaohua ; Kosoglou, Teddy ; Sun, Chengzao ; Huie, Keith ; Greving, Carrie ; Cheng, Xiaoli ; Li, Xinyi ; Liu, David ; Patch, Raymond J ; Li, Shu

AbstractThe interleukin (IL)-23 pathway is a pathogenic driver in psoriasis, psoriatic arthritis, and inflammatory bowel disease. Currently, no oral therapeutics selectively target this pathway. JNJ-77242113 is a peptide targeting the IL-23 receptor with high affinity (KD: 7.1 pM). In human cells, JNJ-77242113 potently and selectively inhibited proximal IL-23 signaling (IC50: 5.6 pM) without impacting IL-12 signaling. JNJ-77242113 inhibited IL-23–induced interferon (IFN)γ production in NK cells, and in blood from healthy donors and psoriasis patients (IC50: 18.4, 11 and 9 pM, respectively). In a rat trinitrobenzene sulfonic acid-induced colitis model, oral JNJ-77242113 attenuated disease parameters at doses ≥ 0.3 mg/kg/day. Pharmacologic activity beyond the gastrointestinal tract was also demonstrated. In blood from rats receiving oral JNJ-77242113, dose-dependent inhibition of ex vivo IL-23–stimulated IL-17A production was observed. In an IL-23–induced rat skin inflammation model, JNJ-77242113 inhibited IL-23–induced skin thickening and IL-17A, -17F and -22 gene induction. Oral dosing of JNJ-77242113 in healthy human volunteers inhibited ex vivo IL-23–stimulated IFNγ production in whole blood. Thus, JNJ-77242113 provided selective, systemic IL-23 pathway inhibition in preclinical models which translated to pharmacodynamic activity in healthy human volunteers, supporting the potential for JNJ-77242113 as a selective oral therapy for IL-23–driven immune-mediated diseases.

110

News (Medical) associated with Icotrokinra

11 Mar 2025

·pmlive.com

J&J/Protagonist’s icotrokinra shows promise in phase 3 plaque psoriasis programme

Johnson & Johnson (J&J) and Protagonist Therapeutics have announced new data from a late-stage programme of their investigational targeted oral peptide in plaque psoriasis. Results from the phase 3 ICONIC-LEAD study presented at this year’s American Academy of Dermatology (AAD) annual meeting showed that the candidate, icotrokinra (JNJ-2113), was associated with significant skin clearance in adults and adolescents aged 12 years and older with moderate-to-severe cases of the immune-mediated skin disease. More than 125 million people worldwide are estimated to be living with plaque psoriasis, which causes inflamed, scaly plaques. These can occur anywhere on the body and may be itchy or painful. Icotrokinra is designed to selectively block the IL-23 receptor, which plays a vital role in the pathogenic T-cell activation of the condition and other immune-mediated inflammatory diseases. In ICONIC-LEAD, 65% of patients receiving once daily icotrokinra achieved an Investigator’s Global Assessment (IGA) score of zero or one (clear or almost clear skin) and 50% achieved at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90), compared to 8% and 4% of those randomised to receive placebo, respectively, at week 16. Continued skin clearance improvement was also reported at week 24, with 74% of icotrokinra-treated patients achieving an IGA score of zero or one and 65% reaching PASI 90. Additionally, 46% of patients receiving icotrokinra achieved IGA zero and 40% reached PASI 100 at week 24. ICONIC-LEAD study investigator, Robert Bissonnette, Innovaderm Research, said: “These study results are promising, and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favourable safety profile in a once daily pill.” The companies also shared promising results from the phase 3 ICONIC-ADVANCE 1 and 2 studies, which are evaluating icotrokinra against both placebo and deucravacitinib in adults with moderate-to-severe plaque plaque psoriasis, and announced the initiation “the first-ever head-to-head study in plaque psoriasis seeking to demonstrate the superiority of an oral pill… compared to an injectable biologic”. Icotrokinra was jointly discovered and is being developed under a licence and collaboration agreement between Protagonist and J&J. J&J has exclusive worldwide rights to develop the candidate in mid-stage clinical trials and beyond, and to commercialise compounds derived from the research conducted in accordance with the agreement against a broad range of indications.

Phase 3Clinical ResultLicense out/inASCO

10 Mar 2025

·www.fiercepharma.com

Trial results enhance Bristol Myers' bid for Sotyktu in psoriatic arthritis

Two successful phase 3 trials have strengthened Bristol Myers Squibb’s bid for Sotyktu in psoriatic arthritis. The company revealed promising data from one of the trials at the American Academy of Dermatology's annual meeting in Orlando. Three months after Bristol Myers Squibb revealed the success of two phase 3 trials of its oral targeted therapy Sotyktu in psoriatic arthritis (PsA), the company has presented detailed data from one of the studies.In the POETYK PsA-2 trial, a significantly greater proportion of those on Sotyktu experienced at least a 20% improvement in their disease than those on placebo. At Week 16, 54% of those on Sotuktu reached the ACR20 response standard compared to 39% on placebo.Additionally, there were no new safety signals as the profile with Sotyktu through week 16 was consistent with previous studies for the tyrosine kinase 2 (TYK2) inhibitor, including a phase 2 trial in PsA and a phase 3 study in plaque psoriasis, which set up Sotyktu for its 2022 approval in the indication. The drug also succeeded on secondary endpoints, with significantly more Sotyktu patients compared to placebo achieving a 75% reduction in symptoms as measured by the Psoriasis Area and Severity Index (PASI). Those on Sotyktu also experienced better outcomes in the patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI) measure compared with those on placebo, BMS reported.“Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” Philip Mease, M.D., a clinical professor at the University of Washington, said in a March 8 press release. “These results are particularly encouraging because they support the potential for Sotyktu to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes.”The data were presented Saturday at the American Academy of Dermatology (AAD) Annual Meeting in Orlando.POETYK PsA-2 enrolled 730 patients who had not used a biologic disease modifying anti-rheumatic drug (bDMARD) or who had previously used a TNF blocker such as AbbVie's Humira. The study also included an arm who received Amgen’s oral PDE4 inhibitor Otezla for a safety reference with no efficacy comparison.BMS said it will present additional data from the POETYK trial program later this year. The company also recently touted the success of the POETYK PsA-1 study in 670 patients who were bDMARD-naive.The drugmaker did not offer a timeline of when it might file for regulatory approval to treat PsA.While there are a multitude of products on the market to treat PsA, in recent years oral therapies have gained the most focus, starting with Otezla, which was brought to the market by Celgene in 2014 before that company sold to BMS for $74 billion in 2019. To clear competition hurdles surrounding the merger, Celgene sold the Otezla franchise to Amgen for $13.4 billion. The plaque psoriasis approval of Sotyktu—which came with BMS estimating its peak sales potential in multiple indications at $4 billion—was based on it outperforming Otezla in skin clearance and safety measures in a head-to-head trial.So far, the uptake of Sotyktu hasn’t quite matched up to the lofty projection, with sales increasing 45% to $246 million in 2024. Meanwhile, Otezla generated $2.1 billion last year, a 3% drop from 2023.Another potential candidate from the same TYK2 class is Takeda’s TAK-279, which the company gained in a $4 billion acquisition of Nimbus Lakshmi.While it’s difficult to make assumptions from cross-trial comparisons, Takeda’s phase 2b study of TAK-279 in PsA showed a marked difference in efficacy when compared to placebo. TAK-279 produced ARC20 response rates of 53% (15 mg) and 54% (30 mg) at Week 12 versus 29% for placebo. Johnson & Johnson also has an oral peptide candidate making noise in JNJ-2113, an IL-23 antagonist. In fact, at the same AAD meeting this weekend, J&J and its partner Protagonist Therapeutics touted topline results for head-to-head trials of the investigational drug against Sotyktu in plaque psoriasis. In a note to clients, Leerink Partners analysts said the outcome "was fully expected based upon historical trial results."J&J's drug, also known as icotrokinra, also met the mark in a separate study in ulcerative colitis.For its part, BMS is also investigating Sotyktu as a treatment for other autoimmune diseases including discoid lupus erythematosus (DLE), systemic lupus erythematosus (SLE) and Sjögren’s syndrome. BMS has advanced its DLE study to phase 2, while the others are in phase 3.

Clinical ResultPhase 3AcquisitionPhase 2Drug Approval

10 Mar 2025

·www.prnewswire.com

Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients

Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program Icotrokinra demonstrates potential to offer therapeutic benefit and tolerability with a once daily oral treatment SPRING HOUSE, Pa., March 10, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint of clinical responsea in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remissionb, symptomatic remission and endoscopic improvement at Week 12. In the ANTHEM-UC study (n=252), three doses of once daily icotrokinra were tested with all meeting the primary endpoint of clinical response at Week 12. A response rate of 63.5% for patients treated with the highest dose of icotrokinra was achieved at Week 12 versus 27% for placebo (p<0.001). Further, 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12 versus 11.1% of patients who received placebo (p<0.001). Remission and response rates continued to improve through Week 28.1 Icotrokinra was well tolerated with proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group.1 "These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases." Comprehensive results from the ANTHEM-UC study are being prepared for presentation at upcoming medical congresses. Editor's notes: a. Clinical response is defined as 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 is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. 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.2 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.3 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,4 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.5,6 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.7 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.8 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.9,10,11 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 or at . 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 , 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. 1Data on file. 2Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. . Accessed February 2025. 3Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 4Bissonnette 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. 5Razawy 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. 6Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 7Pinter 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. 8Johnson & 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: . Accessed November 2024. 9Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: . Accessed November 2024. 10Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: . Accessed November 2024. 11Protagonist 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: . Accessed November 2024. Media contact: Craig Stoltz [email protected] Investor contact: Lauren Johnson [email protected] SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultLicense out/inPhase 3Phase 1

100 Deals associated with Icotrokinra

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 3	Germany	Johnson & Johnson (China) Investment Ltd.	12 Oct 2023
Plaque psoriasis	Phase 3	Germany	Janssen Pharmaceutica NV	12 Oct 2023
Plaque psoriasis	Phase 3	Italy	Johnson & Johnson (China) Investment Ltd.	12 Oct 2023
Plaque psoriasis	Phase 3	Turkey	Janssen Pharmaceutica NV	12 Oct 2023
Plaque psoriasis	Phase 3	France	Janssen Research & Development LLC	12 Oct 2023
Plaque psoriasis	Phase 3	Argentina	Johnson & Johnson (China) Investment Ltd.	12 Oct 2023
Plaque psoriasis	Phase 3	Hungary	Janssen Pharmaceutica NV	12 Oct 2023
Plaque psoriasis	Phase 3	Hungary	Janssen Research & Development LLC	12 Oct 2023
Plaque psoriasis	Phase 3	United Kingdom	Janssen Pharmaceutica NV	12 Oct 2023
Psoriasis	Phase 3	United States	Johnson & Johnson	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06049017 (ANTHEM-UC, NEWS) Manual	Phase 2	Colitis, Ulcerative	252	Icotrokinra	(sneclvphcz) = szqpxgqumt qxafaiiwnr (mlxyphnlfg ) Met View more	Positive	10 Mar 2025
				Placebo	(sneclvphcz) = rhkwuqxrhn qxafaiiwnr (mlxyphnlfg ) Met View more
NCT06095102 (ICONIC-TOTAL, Company_Website) Manual	Phase 3	Plaque psoriasis	-	Icotrokinra	(eepvkinwfq) = positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo. ghxckuthwv (zbkubqekna ) Met	Positive	18 Nov 2024
				Placebo
NCT06095115 (ICONIC-LEAD, NEWS 1 \| NEWS 2) Manual	Phase 3	Plaque psoriasis	-	JNJ-77242113	(ewezjpjtvm) = ilfoufknjq zjptbrngpp (qzkyezcrlr ) Met View more	Positive	18 Nov 2024
				Placebo	(ewezjpjtvm) = kplxqnkcwq zjptbrngpp (qzkyezcrlr ) Met View more
NCT05364554 (FRONTIER 2, PRNewswire) Manual	Phase 2	Plaque psoriasis	227	JNJ-2113	(ncopdnnacu) = lgxdmbbnec uxgpjoztpu (tqodbkwwdv ) View more	Positive	09 Mar 2024
NCT05223868 (FRONTIER 1, Literature) Manual	Phase 2	Plaque psoriasis	255	JNJ-77242113 25 mg once daily	(tvlkwujlod) = cqhjqpdxpk tkpcfngxlb (juekjuftcz ) Met	Positive	08 Feb 2024
				JNJ-77242113 25 mg twice daily	(tvlkwujlod) = egjrudwjnf tkpcfngxlb (juekjuftcz ) Met
NCT05223868 (FRONTIER 1, WCD 12023 \| WCD 22023) Manual	Phase 2	Plaque psoriasis	255	JNJ-77242113 25 mg daily	(cnhkmaibtb) = naaehqaknb slsnsaxxud (xojhbbrmvz ) Met View more	Positive	04 Jul 2023
				JNJ-77242113 25 mg twice daily	(cnhkmaibtb) = mbojuuocpm slsnsaxxud (xojhbbrmvz ) Met View more
NCT04102111 (PRISM, CTgov)	Phase 2	Crohn Disease	48	Placebo (Placebo)	tllavgqepo(fpwkkuxiib) = qfmfqtijil blexyigzhl (dddynzjama, gbpjiwkbfb - awhknpggwc) View more	-	09 Dec 2022
				JNJ-67864238 (JNJ-67864238)	tllavgqepo(fpwkkuxiib) = xvsjoclskg blexyigzhl (dddynzjama, krdfgjyqco - cqhtcwmcip) View more
UEGW2019	Not Applicable	-	-	PTG-200 150 mg QD	(jueshvrjyc) = szzmtgntzk axjjsolhfp (qnrqobrshl, 0.81) View more	-	01 Oct 2019
				PTG-200 300 mg QD	(jueshvrjyc) = qmuwmvwunb axjjsolhfp (qnrqobrshl, 1.23) View more

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis