/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEAD

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了来自ICONIC-LEAD子组分析的icotrokinra（JNJ-2113）新数据

, the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis (PsO) to assess efficacy and safety of a systemic therapy in adolescents and adults simultaneously. These data, presented at the 2025 World Congress of Pediatric Dermatology (WCPD) Annual Meeting, show adolescents treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified..

，这是首个在中度至重度斑块型银屑病（PsO）中评估系统性治疗在青少年和成人中同时进行疗效和安全性的三期注册研究。这些数据在2025年世界儿科皮肤病学大会（WCPD）年会上公布，显示每日一次接受icotrokinra治疗的青少年在第16周时达到皮肤清晰或几乎清晰的比例高于接受安慰剂的患者，且未发现新的安全性信号。

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，目前正针对 12 岁及以上中重度斑块型银屑病（PsO）的成人和青少年进行研究。

In the study, 84.1% of adolescent patients treated with once daily icotrokinra achieved an Investigator's Global Assessment (IGA)

在研究中，84.1%的青少年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 70.5% achieved a Psoriasis Area and Severity Index (PASI)

评分为0/1（皮肤清晰或几乎清晰），并且70.5%的患者达到了银屑病面积和严重程度指数（PASI）

90 response, compared to 27.3% and 13.6% receiving placebo, respectively, at Week 16.

90%的患者在第16周时有反应，相比之下，分别有27.3%和13.6%的患者接受安慰剂。

Response rates continued to improve through Week 24 where 86.4% of adolescents achieved IGA 0/1 (clear or almost clear skin) and 88.6% achieved PASI 90.

第24周时，应答率持续提高，86.4%的青少年达到IGA 0/1（皮肤清晰或几乎清晰），88.6%达到PASI 90。

Further, at Week 24, 75% of adolescents achieved IGA 0 (completely clear skin) and 63.6% achieved PASI 100.

此外，在第24周，75%的青少年达到了IGA 0（完全清除皮肤），63.6%达到了PASI 100。

'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 California, San Diego (UCSD) School of Medicine, ICONIC-LEAD presenter..

“三期临床试验ICONIC LEAD亚组分析的数据展示了令人印象深刻的疗效，显示了这种新型治疗选项在治疗中度至重度斑块型银屑病青少年患者中的潜力，这些患者通常尚未接受过先进疗法，”ICONIC-LEAD报告者、拉迪儿童医院圣地亚哥分院儿科和青少年皮肤科主任、加州大学圣地亚哥分校（UCSD）医学院儿科与医学（皮肤科）教授Lawrence Eichenfield博士表示。

'Young patients with plaque psoriasis face unique challenges due to the visible and uncomfortable nature of the disease, making effective treatment options that align with their needs and preferences all the more important.'

'年轻的斑块型银屑病患者由于疾病的可见性和不适感而面临独特的挑战，因此符合他们需求和偏好的有效治疗方案显得尤为重要。'

Icotrokinra demonstrated a favorable safety profile. At Week 16, 50% of adolescents treated with icotrokinra experienced ≥1 adverse event (AE), compared to 73% of adolescents receiving placebo, with no new safety signals identified.

Icotrokinra 显示出良好的安全性。在第16周，接受 icotrokinra 治疗的青少年中有 50% 经历了至少 1 次不良事件 (AE)，而接受安慰剂的青少年这一比例为 73%，且未发现新的安全信号。

'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.

“患有中度至重度斑块型银屑病的青少年不应等待有潜力实现完全清除皮肤的有效治疗选择，这正是我们作为ICONIC计划的一部分研究这一年轻群体的主要动力，”强生创新药物公司免疫皮肤病学领域副总裁兼疾病领域负责人莉莎·奥道德表示。

'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.'.

“这些数据凸显了下一代疗法的潜力，也显示了icotrokinra有望为中度至重度斑块型银屑病青少年患者提供每日一次口服药的独特组合，兼具良好的安全性与完全的皮肤清除效果。”

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），主要共同终点为 PASI 90 和 IGA 评分 0/1，且至少改善 2 个等级的更高疗效标准。

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 是一个五点量表，严重程度评分范围为 0 到 4，其中 0 表示清晰，1 表示极轻度，2 表示轻度，3 表示中度，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量以及斑块的严重程度（包括红肿、厚度和鳞屑）进行评分。

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

PASI 90 相当于从基线开始 PASI 评分改善了 >=90%。

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

d. 劳伦斯·艾肯菲尔德博士是强生公司的付费顾问。他未因任何媒体工作获得报酬。

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.

icoskinra（JNJ-2113）在中重度斑块型银屑病（PsO）成人和青少年患者中的关键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。

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.

NCT06095115）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

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，旨在评估伊科曲金（icotrokinra）与安慰剂相比治疗中度及以上严重程度的特殊部位（如头皮、生殖器和/或手足）银屑病（PsO）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

NCT06143878

) and ICONIC-ADVANCE 2 (

）和ICONIC-ADVANCE 2（

NCT06220604

NCT06220604

), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.

），这些研究旨在评估icotrokinra与安慰剂及deucravacitinib在中度至重度斑块型银屑病（PsO）成人患者中的有效性和安全性。

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 (

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 1 (

NCT06878404

NCT06878404

) and ICONIC-PsA 2 (

）和 ICONIC-PsA 2 （

NCT06807424

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.

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

About Plaque Psoriasis

关于斑块型银屑病

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情况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，呈现紫色、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了一个人的身体健康，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.

身体高度可见的部位或敏感皮肤上出现银屑病，例如头皮、手部、脚部和生殖器，可能会对生活质量产生更大的负面影响。

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是第一个设计用于选择性阻断IL-23受体的靶向口服肽，

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

这支撑了中度至重度斑块型银屑病和溃疡性结肠炎中的炎症反应，并为其他IL-23介导的疾病提供了潜在可能。

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与IL-23受体结合，并在人T细胞中显示出对IL-23信号传导的强大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公司与强生公司的杨森生物技术公司达成的许可与合作协议，使两家公司能够合作发现和开发最终产生icotrokinra的下一代化合物。

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，并根据双方的许可和合作协议进行开发。Johnson & Johnson 拥有在全球范围内开展 Icotrokinra 的 II 期临床试验及后续开发的专有权，同时也有权将依据该协议进行的研究中衍生出的化合物针对广泛的适应症进行商业化。

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.

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实力使我们能够构建一个世界，在这个世界中，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，我们具备独特的优势，能够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，并对人类健康产生深远影响。