/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO).

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布已向美国食品药品监督管理局（FDA）提交了一份新药申请（NDA），寻求首次批准icotrokinra，这是一种首创的研究性靶向口服肽，可选择性阻断IL-23受体，用于治疗12岁及以上中度至重度斑块型银屑病（PsO）的成人和儿科患者。

Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases..

Icotrokinra 的独特设计可以阻断 IL-23 受体，这是斑块型银屑病 (PsO) 中炎症反应的基础，并在其他 IL-23 介导的疾病中展现出潜力。

The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD

该申请包含了作为ICONIC临床开发计划的一部分而进行的四项关键的III期研究的数据，包括ICONIC-LEAD。

, ICONIC-TOTAL

，标志性总计

and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2

和 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2

. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO.

伊科特罗金治疗在12岁及以上的中度至重度斑块型银屑病（PsO）成人和儿科患者中，达到了所有主要和共同主要终点，显示出显著的皮肤清除效果和良好的安全性，每日一次口服。ICONIC-ADVANCE 1和2研究的结果表明，伊科特罗金达到了共同主要终点，并在中度至重度斑块型银屑病中表现出优于德克拉瓦西替尼的效果。

Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date..

在所有研究中，汇总的安全性数据显示，icotrokinra组（49.1%）和安慰剂组（51.9%）中经历不良事件（AEs）的患者比例相似，迄今为止未发现新的安全性信号。

'The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences,' said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine.

“我们ICONIC临床项目的患者快速入组凸显了对一种能够切实满足其需求和偏好的先进斑块型银屑病治疗的巨大未满足需求，”强生创新医学部免疫皮肤病学和呼吸系统疾病领域负责人、副总裁Liza O'Dowd博士说道。

'Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease.'.

“鉴于我们研究的广度和深度，以及迄今为止报告的强大临床结果，我们相信icotrokinra有潜力改变医生和患者对斑块型银屑病治疗的看法，为这种免疫介导的疾病树立新的治疗标准。”

Data submitted to the FDA as part of the NDA include:

提交给 FDA 的 NDA 数据包括：

Results from the Phase 3 ICONIC-LEAD study,

来自3期ICONIC-LEAD研究的结果，

presented

呈现

as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of Investigator's Global Assessment (IGA)

作为2025年美国皮肤病学会（AAD）年会上的最新突破性摘要发表，结果显示icotrokinra成功达到了研究者全球评估（IGA）的共同主要终点。

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

评分为0/1（皮肤清晰或几乎清晰）和银屑病面积与严重程度指数（PASI）

90 compared to placebo at Week 16.

第16周相比安慰剂为90。

A subgroup analysis of ICONIC-LEAD,

ICONIC-LEAD 的亚组分析，

presented

呈现

at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated pediatric patients 12 years of age and older 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..

在2025年世界儿科皮肤病学大会（WCPD）上，数据显示，12岁及以上接受每日一次伊科特金治疗的儿科患者在第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。

Data from the Phase 3 ICONIC-TOTAL study,

来自3期ICONIC-TOTAL研究的数据，

presented

呈现

at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.

在2025年皮肤病研究学会（SID）年会上，重点介绍了icotrokinra在难以治疗的头皮和生殖器银屑病患者中的潜力。

from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile met 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..

来自III期ICONIC-ADVANCE 1和ICONIC-ADVANCE 2研究的数据显示，进一步巩固了整体疗效，在第16周时达到了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，证明了在中重度斑块型银屑病患者中优于氘可拉西替尼。

Comprehensive results are being prepared for presentation at a future medical meeting.

全面的结果正在准备中，将在未来的医学会议上展示。

Long-term data from the ICONIC development program, including at least 52-weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting.

ICONIC开发项目的长期数据，包括ICONIC-LEAD和ICONIC-TOTAL至少52周的治疗数据，以及一项评估反应持久性的随机撤药分析结果，正准备在未来的医学会议上展示。

Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCEND

强生公司也已启动了第三阶段的ICONIC-ASCEND试验。

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。

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.

ICONIC-LEAD 是一项 III 期随机对照试验 (RCT)，评估 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（至少改善 2 级）。

ICONIC-LEAD enrolled 66 adolescent patients..

ICONIC-LEAD 招募了66名青少年患者。

ICONIC-TOTAL is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) 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. .

ICONIC-TOTAL 是一项 III 期随机对照试验，评估了 icotrokinra 与安慰剂治疗 311 名斑块型银屑病（PsO）患者的疗效和安全性（icotrokinra=208；安慰剂=103），这些患者至少有中度严重程度，影响特殊部位（如头皮、生殖器和/或手足），主要终点为整体 IGA 评分达到 0 或 1 且至少改善 2 个等级。

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.

ICONIC-ADVANCE 1 和 2 是 III 期随机对照试验，评估了依科托金拉与安慰剂及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，主要共同终点为 PASI 90 和 IGA 评分达到 0/1 且至少改善 2 个等级。

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.

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 表示最小，2 表示轻度，3 表示中度，4 表示重度疾病。

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.

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（包括红斑、厚度和鳞屑）进行评分。

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

PASI 90 相应于从基线开始 PASI 评分提高 >=90%。

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.

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

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.

2023年第四季度，根据Protagonist Therapeutics, Inc.的许可和合作协议，icotrokinra（JNJ-2113）用于治疗中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临床开发项目启动了两项研究——ICONIC-LEAD和ICONIC-TOTAL。

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 (

标志性领导（

NCT06095115

NCT06095115

) is a 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，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，共同主要终点为PASI 90和IGA评分达到0或1分且至少改善2级。

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，旨在评估伊科托金拉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.

），这些研究正在评估icotrokinra与安慰剂及deucravacitinib在中度至重度斑块型银屑病（PsO）成人患者中的疗效和安全性。

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.

）将评估伊科曲金拉相对于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。

Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso..

斑块通常表现为隆起的斑块，伴有银白色死皮细胞或鳞屑的堆积。在肤色较浅的人群中，斑块可能呈现红色，而在肤色较深的患者中，则可能更多地呈现紫色、灰色或深棕色。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.

与斑块状银屑病（PsO）一起生活可能会充满挑战，并对一个人的身体健康之外的生活产生影响，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、足部和生殖器，可能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 PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.

这支撑了中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。

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公司与强生旗下的杨森生物技术公司达成的许可与合作协议，使双方能够共同合作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由Protagonist和Johnson & Johnson共同发现，并根据双方的许可与合作协议进行开发。Johnson & Johnson拥有在全球范围内开展icotrokinra二期临床试验及后续开发的专属权利，以及根据协议研究产生的化合物针对广泛适应症进行商业化的权利。

Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, including ICONIC-ASCEND; 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. .

Icotrokinra 正在关键的 III 期 ICONIC 临床开发项目中进行研究，适应症为中度至重度斑块型银屑病，包括 ICONIC-ASCEND；针对活动性银屑病关节炎的 ICONIC-PSA 1 和 ICONIC-PSA 2 研究；以及针对中度至重度活动性溃疡性结肠炎的 IIb 期 ANTHEM-UC 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更少侵入性，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，我们有能力在当今全方位的医疗保健解决方案中进行创新，以提供未来的突破，并对人类健康产生深远影响。