Icotrokinra的结果显示出在斑块型银屑病治疗中树立新标准的潜力-动脉网

Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis

强生等信源发布 2025-03-08 09:48

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Standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift treatment paradigm

每日一次的药丸在完全清除皮肤和安全性方面表现突出，可能改变治疗模式。

Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD

在第三阶段ICONIC-LEAD试验中，接受研究性药物icotrokinra治疗的中至重度斑块型银屑病（PsO）患者中，近一半在第24周达到了完全清除皮肤（IGA 0）。

Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO

第3阶段ICONIC-ADVANCE 1&2研究的初步结果显示icotrokinra达到了共同主要终点，并在中度至重度斑块型银屑病（PsO）中显示出优于deucravacitinib的效果

These results pave the way to initiate the first-ever head-to-head study seeking to demonstrate the superiority of a pill versus injectable biologic in moderate-to-severe plaque PsO

这些结果为启动首个头对头研究铺平了道路，该研究旨在证明药丸相对于注射用生物制剂在中度至重度斑块型银屑病中的优越性。

SPRING HOUSE, Pa.

宾夕法尼亚州斯普林豪斯

，

March 8, 2025

2025年3月8日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new icotrokinra (JNJ-2113) data from its comprehensive Phase 3 clinical program and the start of the first-ever head-to-head study in plaque psoriasis (PsO) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab.

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了其全面的第三阶段临床计划中新的icotrokinra（JNJ-2113）数据，并启动了首个针对斑块型银屑病（PsO）的头对头研究，旨在证明口服药icotrokinra相较于注射型生物制剂ustekinumab的优越性。

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO..

Icotrokinra 是一种首创的研究性靶向口服肽，可选择性阻断 IL-23 受体，目前正被用于研究治疗 12 岁及以上中重度斑块型银屑病（PsO）的成人和青少年。

Data from the Phase 3 ICONIC-LEAD

ICONIC-LEAD 第三期数据

study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, show once daily icotrokinra demonstrated significant skin clearance and a favorable safety profile in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.

研究在2025年美国皮肤病学会（AAD）年会上作为最新突破性摘要发表，结果显示，每日一次的icotrokinra在12岁及以上中度至重度斑块型银屑病（PsO）的成人和青少年中表现出显著的皮肤清除效果和良好的安全性。

In the ICONIC-LEAD study, nearly two-thirds (65%) of patients treated with once daily icotrokinra achieved an Investigator's Global Assessment (IGA)

在ICONIC-LEAD研究中，近三分之二（65%）的患者在接受每日一次的icotrokinra治疗后达到了研究者整体评估（IGA）。

score of 0/1 (clear or almost clear skin) and 50% achieved a Psoriasis Area and Severity Index (PASI)

得分为0/1（皮肤清晰或几乎清晰）并且50%达到了银屑病面积和严重程度指数（PASI）

90 response, compared to 8% and 4% receiving placebo, respectively (P<0.001 for both endpoints) at Week 16.

第16周时，90%的患者有反应，而接受安慰剂的患者分别只有8%和4%（两个终点的P<0.001）。

Continued skin clearance improvement was reported at Week 24 with 74% of patients treated with icotrokinra achieving IGA 0/1 and 65% achieving PASI 90. At Week 24, nearly half of patients treated with icotrokinra achieved completely clear skin – 46% reached IGA 0 and 40% reached PASI 100.

在第24周，报告称皮肤清除效果持续改善，74%接受icotrokinra治疗的患者达到IGA 0/1，65%达到PASI 90。在第24周，近一半接受icotrokinra治疗的患者实现了完全皮肤清除——46%达到IGA 0，40%达到PASI 100。

Similar proportions of patients experienced adverse events (AEs) between icotrokinra (49%) and placebo groups (49%), with no new safety signals identified.

相似比例的患者在依那西普（49%）和安慰剂组（49%）中经历了不良事件（AEs），且未发现新的安全信号。

Results from a subgroup analysis of the ICONIC-LEAD study evaluating icotrokinra in the adolescent population will be presented at a forthcoming medical meeting.

ICONIC-LEAD 研究的亚组分析评估了依那西普在青少年群体中的效果，其结果将在即将召开的医学会议上公布。

'People living with moderate-to-severe plaque psoriasis are seeking options that balance efficacy, safety and ease of use,' said Robert Bissonnette, M.D., Chairman at Innovaderm Research, Montreal, Canada and ICONIC-LEAD study investigator.

“中度至重度斑块型银屑病患者正在寻找能够平衡疗效、安全性和使用便利性的治疗方案，”加拿大蒙特利尔Innovaderm Research主席兼ICONIC-LEAD研究调查员罗伯特·比松内特（Robert Bissonnette）博士表示。

'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 favorable safety profile in a once daily pill.'

“这些研究结果很有希望，显示出使用icotrokinra治疗可为患者提供每日一次口服药物的独特组合，即完全清除皮肤并具有良好的安全性。”

Additionally, topline results show that the Phase 3 ICONIC-ADVANCE 1&2

此外，初步结果显示，第三阶段的ICONIC-ADVANCE 1&2

studies met their co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.

研究在第16周达到了IGA 0/1和PASI 90相对于安慰剂的共同主要终点。Icotrokinra还在第16周和第24周达到了所有关键次要终点，这些终点衡量了其在中度至重度斑块型银屑病患者中相对于deucravacitinib的优越性。

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Based on the positive outcomes of the ADVANCE studies, Johnson & Johnson is initiating the Phase 3 ICONIC-ASCEND

基于ADVANCE研究的积极结果，强生公司正在启动第3阶段的ICONIC-ASCEND研究。

study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab representing an important step forward in psoriasis research.

研究，这是首个头对头研究，旨在证明口服药icotrokinra优于注射用生物制剂ustekinumab，是银屑病研究领域的重要一步。

'The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,' said Liza O'Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. 'As part of our ongoing commitment to pioneer innovations for patients, we are proud to advance this first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, which shows promise as a potential first-line systemic therapy for the treatment of plaque psoriasis.'.

“迄今为止看到的强劲结果突显了icotrokinra在改变中度至重度斑块型银屑病治疗预期方面的潜力，”强生创新医药免疫皮肤病学领域负责人、副总裁丽莎·奥道德表示。“作为我们持续致力于为患者开创创新的一部分，我们很自豪能够推进这一首创的研究性靶向口服肽，它选择性阻断IL-23受体，这有望成为斑块型银屑病治疗的潜在一线系统疗法。”

For further details and the full list of data being presented at the 2025 AAD Annual Meeting, visit

欲了解更多细节和2025年AAD年会展示的完整数据列表，请访问

https://innovativemedicine.jnj.com/focus-areas/immunology/immudermatology-newsroom

。

Editor's notes:

编辑注释：

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.

a. ICONIC-LEAD 是一项 III 期随机对照试验 (RCT)，评估了 icotrokinra 与安慰剂在 684 名 12 岁及以上中至重度斑块型银屑病 (PsO) 患者中的疗效和安全性（icotrokinra=456；安慰剂=228），主要终点是 PASI 90 和 IGA 评分 0/1，且至少改善 2 个等级。

ICONIC-LEAD enrolled 66 adolescent patients..

ICONIC-LEAD 招募了66名青少年患者。

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.

b. IGA是一个五分制量表，严重程度评分范围为0到4，其中0表示清晰，1为极小，2为轻度，3为中度，4表示重度疾病。

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.

c. PASI评分对每个身体区域被银屑病斑块覆盖的表面积以及斑块的严重程度（包括红肿、厚度和鳞屑）进行分级。

PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.

PASI 90 相应于从基线开始 PASI 评分提高 >=90%。

d. Dr. Robert Bissonnette is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

d. 罗伯特·比松内特博士是强生公司的有偿顾问。他未因任何媒体工作获得报酬。

e. ICONIC- ADVANCE 1 & 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in 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.

e. ICONIC-ADVANCE 1 和 2 是 III 期随机对照试验，评估了伊科托金拉与安慰剂和德克拉瓦西替尼在中至重度斑块型银屑病（PsO）患者中的疗效和安全性，这些患者的 PASI 90 和 IGA 评分达到 0/1，并且至少有 2 级改善作为共同主要终点。

f. ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.

f. ICONIC-ASCEND 是一项三期随机对照试验，也是首个头对头研究，旨在证明口服药icotrokinra与注射用生物制剂ustekinumab相比，在治疗中至重度斑块型银屑病（PsO）中的优越性。

About the ICONIC Clinical Development Program

关于ICONIC临床开发计划

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.

icotrokinra（JNJ-2113）用于治疗中度至重度斑块型银屑病（PsO）成人和青少年患者的关键性III期ICONIC临床开发项目于2023年第四季度启动了两项研究——ICONIC-LEAD和ICONIC-TOTAL——依据Protagonist Therapeutics, Inc.之间的许可与合作协议。

and Janssen Biotech, Inc., a Johnson & Johson company..

和杨森生物技术公司（Janssen Biotech, Inc.），一家强生公司。

ICONIC-LEAD (

标志性领先 (

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.

）是一项随机对照试验（RCT），旨在评估icotrokinra与安慰剂在中至重度斑块型银屑病（PsO）患者中的疗效和安全性，以PASI 90和IGA评分达到0或1且至少改善2级作为共同主要终点。

ICONIC-TOTAL (

标志性总计 (

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..

）是一项随机对照试验，旨在评估icotrokinra与安慰剂相比治疗中度及以上严重程度影响特殊部位（如头皮、生殖器和/或手足）的PsO患者的疗效和安全性，主要终点为整体IGA评分达到0或1分，并且至少改善2个等级。

Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (

开发项目中的其他 3 期研究包括 ICONIC-ADVANCE 1 （

NCT06143878

) and ICONIC-ADVANCE 2 (

）和 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.

），这些试验正在评估icotrokinra与安慰剂及deucravacitinib在中至重度斑块型银屑病（PsO）成人患者中的疗效和安全性。

9,10

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 2 (

ICONIC-ASCEND 将评估icotrokinra与安慰剂和ustekinumab在中度至重度斑块型银屑病患者中的疗效和安全性。ICONIC-PsA 2 (

NCT06807424

) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.

）将评估icotrokinra与安慰剂在活动性银屑病关节炎参与者中的疗效和安全性。

About Plaque Psoriasis

关于斑块状银屑病

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.

斑块型银屑病（PsO）是一种慢性免疫介导的疾病，会导致皮肤细胞过度增生，从而引发发炎、鳞屑状的斑块，可能伴有瘙痒或疼痛。

It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.

据估计，美国有800万人、全球有超过1.25亿人患有这种疾病。

Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.

将近四分之一的斑块型银屑病患者的病情被认为是中度至重度。

On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale.

在白种人皮肤上，斑块通常表现为隆起的红色斑块，表面覆盖着银白色的死皮细胞或鳞屑。

On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color.

在深色皮肤上，斑块可能显得更暗、更厚，呈紫色、灰色或深棕色。

Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows and torso.

斑块可以出现在身体的任何部位，但最常见于头皮、膝盖、肘部和躯干。

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.

与斑块型银屑病（PsO）共存可能是一个挑战，它对生活的影响超出一个人的身体健康，包括心理健康、人际关系以及应对生活中的压力源。

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.

身体上高度可见的部位或敏感皮肤区域，如头皮、手、脚和生殖器上的牛皮癣，可能对生活质量产生更大的负面影响。

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About Icotrokinra (JNJ-77242113, JNJ-2113)

关于Icotrokinra（JNJ-77242113，JNJ-2113）

Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,

研究性药物icotrokinra是首个旨在选择性阻断IL-23受体的靶向口服肽，

which underpins the inflammatory response in moderate-to-severe plaque psoriasis (PsO), ulcerative colitis (UC) and offers potential in other IL-23-mediated diseases.

这支撑了中度至重度斑块型银屑病（PsO）、溃疡性结肠炎（UC）的炎症反应，并在其他IL-23介导的疾病中提供了潜在可能。

17,18

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.

Icotrokinra以个位数皮摩尔的亲和力结合IL-23受体，并在人类T细胞中显示出对IL-23信号传导的有效且选择性的抑制作用。

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.

2017年，Protagonist Therapeutics公司与强生旗下的Janssen Biotech公司达成许可和合作协议，使双方能够共同发现和开发下一代化合物，最终促成了icotrokinra的诞生。

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..

Icotrokinra是由Protagonist和Johnson & Johnson共同发现的，并根据双方的许可与合作协议进行开发。Johnson & Johnson保留在第二阶段临床试验及以后阶段开发icotrokinra的全球独家权利，同时拥有基于该协议研究成果针对广泛适应症开发和商业化相关化合物的权利。

21,22,23

21，22，23

Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque PsO and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active UC.

Icotrokinra 正在关键的 III 期 ICONIC 临床开发项目中进行研究，用于中度至重度斑块型银屑病（PsO）和活动性银屑病关节炎，同时还在 IIb 期 ANTHEM-UC 研究中针对中度至重度活动性溃疡性结肠炎（UC）进行研究。

About Johnson & Johnson

关于强生公司

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..

在强生，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够构建一个世界，在这个世界里，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且侵入性更小，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今整个医疗保健解决方案领域进行创新，提供明日的突破性成果，从而对人类健康产生深远影响。

Learn more at

了解更多内容，请访问

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

。

关注我们

@JNJInnovMed

。

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.

扬森研究与发展有限责任公司和扬森生物科技公司是强生公司的子公司。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

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.

本新闻稿包含根据1995年《私人证券诉讼改革法案》定义的关于icotrokinra（JNJ-2113）的“前瞻性声明”。读者应注意不要过度依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。如果基本假设被证明不准确，或已知或未知的风险或不确定性变为现实，实际结果可能与Janssen Research & Development, LLC和Janssen Biotech, Inc.的预期和预测存在重大差异。

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.

和/或强生公司。风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；专利面临的挑战；产品功效或安全问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗改革；以及控制医疗成本的趋势。

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.

这些风险、不确定性及其他因素的进一步列表和描述，请参见强生公司最近的Form 10-K年度报告，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的Form 10-Q季度报告和其他提交给证券交易委员会的文件。

Copies of these filings are available online at .

这些文件的副本可在线获取，网址为。

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.

或应强生公司的要求。杨森研发有限责任公司、杨森生物科技公司及强生公司均不承担因新信息、未来事件或发展而更新任何前瞻性声明的义务。

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.

比松内特，R 等。Icotrokinra，一种靶向口服肽，选择性阻断白细胞介素-23受体，用于治疗中度至重度斑块型银屑病：第三阶段随机双盲安慰剂对照ICONIC-LEAD试验的第24周结果。2024年美国皮肤病学会（AAD）年会最新突破性研究展示（摘要#66708）。

March 2025..

2025年3月

Data on file.

数据存档。

Data on file.

数据存档。

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.

辛普森 E、比松内特 R、艾肯菲尔德 LF 等。经验证的特应性皮炎全局评估（vIGA-AD™）：一种用于特应性皮炎严重程度的新型临床结果测量工具的开发与可靠性测试［在线发表于2020年4月25日］。《美国皮肤病学会杂志》。

doi: 10.1016/j.jaad.2020.04.104. Accessed March 2025..

doi: 10.1016/j.jaad.2020.04.104。引用日期：2025年3月。

Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at:

汤普森 Jr，D. 银屑病面积和严重程度指数如何运作。每日健康。可用地址：

https://www.everydayhealth.com/psoriasis/living-with/how-the-pasi-index-works

. Accessed March 2025.

. 2025年3月访问。

Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at:

Protagonist Therapeutics发布新闻稿，宣布JNJ-2113在多个适应症上取得进展。可用链接：

https://www.accesswire.com/791174/protagonist-announces-advancement-of-jnj-2113-across-multiple-indications

https://www.accesswire.com/791174/主角宣布JNJ-2113在多个适应症中的进展

. Accessed March 2025.

。访问时间：2025年3月。

Clinicaltrials.gov

临床试验.gov

. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115.

. 针对中度至重度斑块型银屑病青少年和成人参与者使用JNJ-2113的研究（ICONIC-LEAD）。标识符：NCT06095115。

https://classic.clinicaltrials.gov/ct2/show/NCT06095115

. Accessed March 2025.

。访问时间：2025年3月。

Clinicaltrials.gov

临床试验.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.

针对斑块型银屑病（涉及特殊部位，如头皮、生殖器和/或手掌和脚底）患者使用JNJ-2113进行治疗的研究（ICONIC-TOTAL）。标识符：NCT06095102。

https://classic.clinicaltrials.gov/ct2/show/NCT06095102

. Accessed March 2025.

访问日期：2025年3月。

Clinicaltrials.gov

临床试验.gov

. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878.

一项关于JNJ-77242113治疗中度至重度斑块型银屑病患者的研究。标识符：NCT06143878。

https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10

. Accessed March 2025.

。访问时间：2025年3月。

Clinicaltrials.gov

临床试验.gov

. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604.

. 一项关于JNJ-77242113治疗中度至重度斑块型银屑病患者的研究（ICONIC-ADVANCE 2）。标识符：NCT06220604。

https://clinicaltrials.gov/study/NCT06220604

. Accessed March 2025.

访问时间：2025年3月。

National Psoriasis Foundation. About Psoriasis. Available at:

国家银屑病基金会。关于银屑病。可用资源：

https://www.psoriasis.org/about-psoriasis

. Accessed March 2025.

访问时间：2025年3月。

National Psoriasis Foundation. Psoriasis Statistics. Available at:

国家银屑病基金会。银屑病统计。可见于：

https://www.psoriasis.org/content/statistics

. Accessed March 2025.

. 2025年3月访问。

National Psoriasis Foundation. Plaque Psoriasis. Available at:

国家银屑病基金会。斑块型银屑病。可用链接：

https://www.psoriasis.org/plaque/

. Accessed March 2025.

访问时间：2025年3月。

National Psoriasis Foundation. Life with Psoriasis. Available at:

国家银屑病基金会。银屑病生活。可用地址：

https://www.psoriasis.org/life-with-psoriasis/

. Accessed March 2025.

。访问时间：2025年3月。

National Psoriasis Foundation. High Impact Sites. Available at:

国家银屑病基金会。高影响力网站。可访问：

https://www.psoriasis.org/high-impact-sites/

. Accessed Sep March 2025.

。访问日期：2025年3月。

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.

比松内特 R 等。数据展示。一项二期、随机、安慰剂对照、剂量范围研究，评估口服 JNJ-77242113 治疗中至重度斑块型银屑病：FRONTIER 1。在 2023 年世界皮肤病学大会（WCD）上发表，7月3日至8日。

Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling.

Razawy W, 等。IL‐23受体信号在炎症介导的侵蚀性自身免疫性关节炎和骨重塑中的作用。

Eur J Immunol

欧洲免疫学杂志

. 2018 Feb; 48(2): 220–229.

2018年2月；48（2）：220-229。

Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases.

唐 C 等。白细胞介素-23：作为自身免疫性炎症疾病的药物靶点。

Immunology

免疫学

. 2012 Feb; 135(2): 112–124.

. 2012年2月；135（2）：112-124。

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.

Pinter A等，数据展示。JNJ-77242113治疗在斑块型银屑病患者的血清样本中相较安慰剂引发强烈的全身药效学反应：来自2期FRONTIER 1研究的结果。在2023年EADV大会（10月11日至14日）上展示。

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:

强生公司新闻发布。杨森与Protagonist Therapeutics, Inc.达成了一项全球独家许可和合作协议，针对用于治疗炎症性肠病的口服白细胞介素-23受体拮抗剂候选药物。可用链接：

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

https://www.jnj.com/media-center/press-releases/杨森与Protagonist Therapeutics达成全球独家许可及合作协议，针对炎症性肠病治疗的口服白细胞介素-23受体拮抗剂候选药物

. Accessed March 2025.

。访问时间：2025年3月。

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:

Protagonist Therapeutics发布新闻稿，宣布与Janssen Biotech修订协议，继续开发和商业化IL-23拮抗剂。可用链接：

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

https://www.prnewswire.com/news-releases/protagonist-therapeutics-宣布与janssen-biotech就il-23拮抗剂的持续开发和商业化协议进行修订-301343621.html

. Accessed March 2025.

. 2025年3月访问。

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:

主角治疗公司。新闻稿。主角报告了口服白细胞介素-23受体拮抗剂JNJ-2113的1期和临床前研究的积极结果。可用链接：

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 2025.

访问日期：2025年3月。

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:

主角治疗公司。新闻稿。主角治疗公司宣布其口服IL-23受体拮抗剂JNJ-2113（PN-235）在银屑病的2b期FRONTIER 1临床试验中取得了积极的初步结果。可用链接：

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 2025.

。访问日期：2025年3月。

Media contact:

媒体联系人：

Meg Farina

梅格·法琳娜

mfarina@its.jnj.com

Investor contact:

投资者联系方式：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com