An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease

Crohn's disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib's mechanism of action in CD and evaluate how safe this treatment is.
The participants will be treated with zasocitinib for 3 months (12 weeks) and will need to undergo a test where a doctor uses a thin, flexible tube with a tiny camera to look inside the large bowel (colon) and the end of the small bowel (ileum); this test is called ileocolonoscopy.
During the study, participants will visit the study clinic several times.

开始日期2026-07-15

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT07286058

/ Recruiting临床3期

A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.
The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.
Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).
Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.

开始日期2026-03-11

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT07244263

/ Recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS) is a skin condition that causes deep, painful bumps on the skin. These bumps usually appear in an area where the skin rubs together. They start as small bumps but may become swollen and red over time. If they fill with pus, these lumps are called abscesses; these can also burst. Over time, the area can get scars and tunnels on or under the skin. Recent studies suggest that the condition may start when hair follicles become damaged and blocked. This impacts the skin and may activate the body's germ-fighting (immune) system. This allows bacteria to grow on the skin which worsens the condition and can cause abscesses.
The main aims of this study are to learn how safe zasocitinib is, how well it works and how well adults with HS tolerate it compared with a placebo.
The participants will receive the study treatment (either zasocitinib or placebo) for up to 4 months (16 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. After the first 4 months, all participants (also those who initially received placebo) will then receive zasocitinib for up to 8 months (36 weeks).
During the study, participants will visit their study clinic 12 times.

开始日期2026-01-26

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与扎索替尼相关的临床结果

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100 项与扎索替尼相关的转化医学

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100 项与扎索替尼相关的专利（医药）

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项与扎索替尼相关的文献（医药）

2026-06-01·Dermatology and Therapy

Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial

Article

作者: Green, Lawrence ; Laquer, Vivian ; Vender, Ronald ; Weisman, Jamie ; Zhang, Wenwen ; Gooderham, Melinda J ; Winkelman, Warren ; Armstrong, April W ; Elbuluk, Nada ; Bhutani, Tina ; Moore, Angela ; Ferris, Laura K

INTRODUCTION:

Zasocitinib (TAK-279) is an investigational, once daily, oral, allosteric, highly selective, and potent tyrosine kinase 2 inhibitor. Post hoc analyses of a 12-week phase IIb trial in patients with moderate-to-severe plaque psoriasis evaluated zasocitinib 15 mg or 30 mg efficacy versus placebo by baseline characteristic subgroups, Psoriasis Area and Severity Index (PASI) improvements by body region and component scores, and patient-reported and other clinical outcomes.

METHODS:

Disease severity assessments included PASI, Physician's Global Assessment (PGA), body surface area (BSA), Dermatology Life Quality Index (DLQI) 0/1, and PGA × BSA. Subgroups included weight, sex, age, race, disease duration, prior biologic use, and PASI score. Body regions included head, trunk, and upper and lower extremities. Scoring components included erythema, induration, and desquamation. DLQI 0/1 attainment was assessed by PASI.

RESULTS:

At week 12, zasocitinib 15 mg or 30 mg demonstrated greater response rates in PASI 75/90/100 and PGA 0/1 in nearly all patient subgroups versus placebo. A greater proportion of patients receiving zasocitinib achieved PASI 75/90/100 across all PASI body regions and scoring components versus placebo. Reductions in BSA or PASI were greater in zasocitinib groups as early as week 2 and through week 12 versus placebo; most patients attaining PASI ≤ 1 or ≤ 2 or PASI 75/90/100 also achieved DLQI 0/1. Absolute PASI and PGA × BSA improvements were strongly positively correlated (ρ = 0.95), with PGA × BSA 75 and PASI 75 showing high agreement.

CONCLUSION:

Zasocitinib demonstrated consistent improvements in skin clearance, irrespective of baseline disease characteristics, PASI body region, and scoring component, with meaningful quality of life improvements. Graphical abstract available for this article.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04999839.

2026-05-01·Skin therapy letter

Zasocitinib: New Frontier in Tyrosine Kinase 2 Inhibition.

Review

作者: Sauder, Maxwell ; Adam, Samantha R

Zasocitinib is a novel highly selective tyrosine kinase 2 (TYK2) inhibitor that is in late phase development for the treatment of psoriasis and psoriatic arthritis. This article will review its efficacy, safety and tolerability. Currently, deucravacitinib is the only TYK2 inhibitor with regulatory approval from most major authorities. Zasocitinib offers potential benefits, as it has higher target selectivity and affinity of the Janus homology 2 (JH2) domain of TYK2 as compared to deucravacitinib. This selectivity leads to minimal inhibition of Janus kinase (JAK) 1, JAK2 and JAK3 (JAK1-3), and therefore may result in less off-target effects that have been associated with other molecules.

2026-05-01·JOURNAL OF INVESTIGATIVE DERMATOLOGY

Molecular, histological, and clinical effects of selective TYK2 inhibition with zasocitinib (TAK-279) in patients with moderate-to-severe plaque psoriasis

Article

作者: Rambhia, Darshna ; Krueger, James G ; Blau, Jessamyn ; Hong, Feng ; Kumar, Sachin ; Tang, Jay ; Wennbo, Håkan ; Cheng, Jie ; Saha, Banishree ; Arunachalam, Vinayagam ; Kunjravia, Norma ; Choudhury, Amit ; Thakker, Paresh ; Li, Xuan ; Garcet, Sandra ; Zhang, Wenwen ; Cueto, Inna

686

项与扎索替尼相关的新闻（医药）

12 小时之前

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【里程碑】武田制药泽索昔替尼 3 期数据出炉：头皮、甲、掌跖难治银屑病实现高皮损清除

● 在第16周，平均约75%接受Zasocitinib (中译：泽索昔替尼*，下称泽索昔替尼)治疗的头皮银屑病患者，以及约70%接受泽索昔替尼治疗的掌跖部位银屑病患者达到皮损清除或几乎清除。● 与安慰剂相比，泽索昔替尼在甲银屑病严重程度指数（NAPSI）方面显示出具有统计学意义的改善。● 结果进一步支持泽索昔替尼有望成为中度至重度斑块状银屑病患者的便捷的每日一次口服治疗选择，帮助患者实现快速、持久且有意义的全身皮损清除，包括最难治部位。2026年7月16日 - 武田制药（TSE:4502/NYSE:TAK）公布了泽索昔替尼（TAK-279）两项针对中重度斑块状银屑病（PsO）成人患者的关键性3期研究新数据。泽索昔替尼是一种新一代、高度选择性且强效的口服酪氨酸激酶 2（TYK2）抑制剂。1 在2026年美国皮肤病学会（AAD）Innovation Academy上公布的这些次要终点数据显示，与安慰剂相比，泽索昔替尼在难治和高影响部位，包括头皮、指/趾甲、手掌和足底显示出一致且高皮损清除率。1-5这些数据建立在3期随机、多中心、双盲、安慰剂和活性药物对照的Latitude PsO 3001和3002研究的顶线结果基础之上。在这两项研究中，约70%接受泽索昔替尼治疗的患者在第16周达到静态医师整体评估（sPGA）0/1（皮损清除或几乎清除），且银屑病面积和严重程度指数（PASI）75应答率早在第4周即显著高于安慰剂组，并持续提高至第24周。整体数据表明，即使在最难治的部位，泽索昔替尼也有望实现快速且持久的皮损清除。2,6“银屑病是一种复杂的异质性疾病，在不同患者之间以及疾病进程中可表现出不同的临床特征，尤其是在难治的高影响部位。”武田制药高级副总裁、消化及炎性疾病治疗领域负责人Chinwe Ukomadu博士（MD, PhD）表示，“TYK2 在调节驱动疾病的核心免疫通路中发挥关键作用，包括IL-23/IL-17轴和I型干扰素通路，这些通路会导致疾病表现和治疗应答存在差异。我们的3期研究结果进一步支持这款新一代TYK2抑制剂有望通过便捷的每日一次口服方案实现快速、持久且一致的皮损清除。”3期银屑病研究中高影响部位的结果3001和3002研究还评估了基线时患有甲银屑病，或至少患有中度头皮或掌跖银屑病的患者。2 研究结果在全身各部位保持一致，包括难治和高影响部位：2-5头皮：在第16周，接受泽索昔替尼治疗的头皮银屑病患者中，77%和74%达到头皮特异性医师整体评估（ssPGA）0/1应答；安慰剂组为7%和13%（p<0.001）；阿普米司特（apremilast）组为42%和30%（p<0.001）。2手掌和足底（掌跖）：在第16周，约70%接受泽索昔替尼治疗的掌跖银屑病患者中达到手和/或足医师整体评估（hfPGA）0/1应答（71%和69%），在数值上高于安慰剂组（22%和10%）及阿普米司特组（44%和43%）。2指甲：与安慰剂相比，泽索昔替尼在第16周甲银屑病严重程度指数（NAPSI）方面也实现了具有统计学意义的改善（p<0.001）。2● 两项研究中的应答均持续至第24周。2● 截至第24周，最常见的不良事件为上呼吸道感染、鼻咽炎和痤疮，未发现新的安全性信号。2“尽管银屑病治疗已取得进展，许多患者仍持续受到症状困扰，尤其是在头皮等高度暴露或敏感部位。头皮银屑病影响约一半的银屑病患者，并可能对日常生活造成更大程度的影响。”肯塔基州路易斯维尔Skin Sciences和Physicians Skin Care创始人兼医学总监、Latitude PsO研究主要研究者及报告作者Leon Kircik博士（MD）表示，“这些研究结果显示，泽索昔替尼在最难治疗的部位也能带来一致的皮损清除效果，包括头皮、甲、手掌和足底，进一步显示出其有望成为重要的口服治疗选择，帮助患者实现有意义的全身皮损清除。”泽索昔替尼的下一步计划武田制药计划自本财年起，向美国食品药品监督管理局及其他监管机构提交泽索昔替尼用于治疗斑块状银屑病的新药上市申请。泽索昔替尼也正在开展银屑病关节炎的3期研究，以及克罗恩病、溃疡性结肠炎、白癜风和化脓性汗腺炎（HS）的2期研究。7-12 关于斑块状银屑病银屑病是一种慢性、系统性、免疫介导的炎症性疾病，其特征为瘙痒、疼痛、影响外观并可致残的皮损，影响患者的身体、情绪和心理健康。13-19 全球约有6400万银屑病患者，其中约80–90%为斑块状银屑病。20-21 持续瘙痒、皮损的出现和发生部位（尤其是在高度暴露或敏感区域），以及银屑病关节炎等相关合并症，均是降低生活质量的重要因素，并可能对日常生活产生显著影响。16-19 银屑病也是一种异质性疾病，由复杂且相互关联的免疫通路、遗传和环境因素驱动。这些因素在不同患者之间及同一患者疾病进程的不同时期存在差异，从而导致病程、症状和治疗应答存在差异。22-26 关于泽索昔替尼（TAK-279）泽索昔替尼是一款在研的新一代高选择性且强效的口服TYK2抑制剂，可实现24小时持续抑制IL-23以及其他驱动疾病进展的核心免疫通路。27-31它有望成为银屑病患者的重要的口服治疗选择，并可能通过便捷的每日一次口服方案实现快速且持久的皮损清除。6 根据体外研究数据，泽索昔替尼对TYK2的选择性比对其他JAK酶家族成员高出一百万倍以上，这一特性意味着其能够在不影响JAK1、JAK2和JAK3信号通路的情况下最大化TYK2的抑制作用。27-28 武田目前正评估泽索昔替尼在银屑病关节炎3期研究，以及克罗恩病、溃疡性结肠炎、白癜风和化脓性汗腺炎（HS）2期研究中的安全性和疗效。7-12泽索昔替尼目前仍处于研究阶段，尚未获得任何监管机构的上市批准。关于LATITUDEPsO 3期研究Latitude 3期银屑病研究（NCT06088043和NCT06108544）为全球多中心、随机、双盲、安慰剂与活性药物对照的临床试验，旨在评估泽索昔替尼在中度至重度斑块状银屑病成人患者中的疗效、安全性与耐受性。32-33 两项研究在21个国家开展，分别入组了693名和1,108名受试者。研究的共同主要终点为与安慰剂比较，接受泽索昔替尼治疗的患者在第16周达到sPGA 0/1以及PASI 75的应答率。32-33 排序（关键）次要终点包括在第16周与安慰剂的比较，以及在第16周和第24周与阿普米司特（apremilast）的比较等。32-33评估高影响部位的次要终点包括：● 头皮（分别在38%和28%的总体研究人群中评估）：2在第16周（相较于安慰剂和/或阿普米司特）和第24周（相较于阿普米司特）达到头皮银屑病特异性医师整体评估（ssPGA）应答的患者比例（定义为清除[0]或几乎清除[1]，且较基线下降≥2分；适用于基线ssPGA≥3、基线头皮银屑病严重程度指数≥12且头皮受累面积≥30%的患者）；32-33● 手掌和足底（掌跖；分别在24%和22%的总体研究人群中评估）：2在第16周（相较于安慰剂和/或阿普米司特）和第24周（相较于阿普米司特）达到手掌和/或足底PGA（hfPGA）应答的患者比例（定义为清除[0]或几乎清除[1]，且较基线下降≥2分；适用于基线hfPGA≥3的患者）；32-33● 指甲（分别在37%和30%的总体研究人群中评估）：2在第16周（相较于安慰剂），基线时存在甲受累患者的甲银屑病严重程度指数（NAPSI）较基线的变化（CfB）。32-33 关于酪氨酸激酶2（TYK2）抑制剂TYK2是银屑病核心炎症通路的关键介导因子，包括IL-23/IL-17轴和I型干扰素信号通路。由于单一通路抑制可能无法充分控制所有患者的疾病，因此TYK2是一个有前景的治疗靶点。26,30,34 TYK2是一种细胞内酶，属于Janus激酶（JAK）蛋白家族成员之一。26-27 但其与JAK1、JAK2和JAK3不同，TYK2主要调节免疫反应，而JAK1、2和3则参与更广泛的生物学过程，如脂质代谢和造血；这些过程一旦受到干扰，可能与心血管疾病风险增加和血液系统疾病相关。26-27,35 通过对 TYK2 的高度选择性变构抑制，并尽量减少对JAK1、JAK2和JAK3的影响，是一种有前景的治疗策略，可用于靶向免疫介导的炎症，同时有望降低抑制其他JAK家族成员带来的风险。31 关于武田制药武田制药以“为人类创造健康生活，为世界缔造美好未来”为使命。我们专注于消化和炎症性疾病、罕见病、血液制品、肿瘤、神经科学及疫苗等关键治疗领域，着力研发并为患者带来突破性的创新疗法。我们的目标是携手合作伙伴，打造动态化和多样化的产品管线，不断改善患者体验，并拓展对前沿性治疗方案的探索。武田制药总部位于日本，作为一家以价值观为基础、以研发为驱动的全球化生物制药公司，我们始终致力于兑现对患者、员工和地球的承诺。我们遍布全球80多个国家和地区的员工肩负着相同的使命，始终践行两个多世纪以来形成的价值观。参考资料：1. The topline results of these studies were disclosed on December 18, 2025 in, “Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment”.2. Armstrong AW, et al. Zasocitinib, a once-daily oral TYK2 inhibitor, demonstrates efficacy at high impact sites in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002. Presented at the 2026 American Academy of Dermatology Innovation Academy. 2026 July 16; New York, NY.3. Dopytalska K, Sobolewski P, Błaszczak A, Szymańska E, Walecka I. Psoriasis in Special Localizations. Reumatologia. 2018;56(6):392-398. doi:10.5114/reum.2018.80718.4. Lupulescu AM, Savu AP, Bucur Ş, Şerban ED, Popescu S, Constantin MM. Hard-to-Treat Areas in Psoriasis: An Underevaluated Part of the Disease. Life (Basel). 2025;15(3):425. Published 2025 Mar 7. doi:10.3390/life150304255. Butacu A-I, Toma C, Negulet I-E, Manole I, Banica AN, Plesea A, Badircea IA, Iancu I, Tiplica G-S. Updates on Psoriasis in Special Areas. Journal of Clinical Medicine. 2024; 13(24):7549. https://doi.org/10.3390/jcm132475496. Gooderham M, et al. Once-daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002). Presented at American Academy of Dermatology 2026. 2026 Mar 28; Denver, CO.7. Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated June 29, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT06671483. 8. A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671496. Updated June 29, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT06671496. 9. A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov Identifier: NCT06233461. Updated May 8, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT06233461. 10. A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov Identifier: NCT06254950. Updated May 22, 2026. Accessed July 2026. https://www.clinicaltrials.gov/study/NCT06254950. 11. A Study of Zasocitinib in Adults With Nonsegmental Vitiligo. ClinicalTrials.gov Identifier: NCT07108283. Updated June 12, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT07108283. 12. A Takeda Presentation. Quarterly Results - Quarter 1 FY2025. Available at: https://assets-dam.takeda.com/image/upload/v1753839858/Global/Investor/Financial-Results/FY2025/Q1/qr2025_q1_p01_en.pdf. Accessed July 2026.13. Langley RGB, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(Suppl 2):ii18–23.14. Bhosle, MJ, Kulkarni A, et al. Quality of life in patients with psoriasis. Health Qual Life Outcomes. 2006;35(4). https://doi.org/10.1186/1477-7525-4-35. 15. Dhabale A, Nagpure S. Types of psoriasis and their effects on the immune system. Cureus. 2022 Sep 24;14(9):e29536. doi: 10.7759/cureus.29536.16. Taliercio VL, Snyder AM, Webber LB, et al. The Disruptiveness of Itchiness from Psoriasis: A Qualitative Study of the Impact of a Single Symptom on Quality of Life. J Clin Aesthet Dermatol. 2021;14(6):42-48.17. Snyder AM, Taliercio VL, Webber LB, et al. The Role of Pain in the Lives of Patients with Psoriasis: A Qualitative Study on an Inadequately Addressed Symptom. J Psoriasis Psoriatic Arthritis. 2022 Jan;7(1):29-34. doi: 10.1177/24755303211066928. Epub 2021 Dec 12. PMID: 39296728; PMCID: PMC11361505.18. Dopytalska K, Sobolewski P, Błaszczak A, Szymańska E, Walecka I. Psoriasis in Special Localizations. Reumatologia. 2018;56(6):392-398. doi:10.5114/reum.2018.80718.19. Blackstone B, Patel R, Bewley A. Assessing and Improving Psychological Well-Being in Psoriasis: Considerations for the Clinician. Psoriasis (Auckl). 2022;12:25-33.doi:10.2147/PTT.S3284420. AIQassimi S, AIBrashdi S, Galadari H, Hashim MJ. Global Burden of Psoriasis - Comparison of Regional and Global Epidemiology, 1990 to 2017. Int J Dermatol. 9. 2020;59(5):566-571. doi: 10.llll/ijd.14864.21. Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025. https://www.ncbi.nlm.nih.gov/books/NBK43087.22. Narayanan S, Guyatt V, Franceschetti A, Hautamaki EL. Disease burden and patient reported outcomes among patients with moderate to severe psoriasis: an ethnography study. Psoriasis (Auckl). 2014;5:1-7. Published 2014 Dec 23. doi:10.2147/PTT.S7490623. Elmets CA, Leonardi CL, Davis DMR, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. J Am Acad Dermatol. 2019;80(4):1073-1113. doi:10.1016/j.jaad.2018.11.058.24. Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 221;397(10281):1301-1315. doi:10.1016/S0140-6736(20)32549-6.25. Gooderham MJ, Papp KA, Lynde CW. Shifting the focus - the primary role of IL-23 in psoriasis and other inflammatory disorders. J Eur Acad Dermatol Venereol. 2018;32(7):1111-1119. doi:10.1111/jdv.1486826. Muromoto R, Oritani K, Matsuda T. Current understanding of the role of tyrosine kinase 2 signaling in immune responses. World J Biol Chem. 2022;13(1):1–14. doi:10.4331/wjbc.v13.i1.1.27. Leit S, Greenwood J, Carriero S, et al. Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279. J Medicinal Chemistry.2023;66(15):10473-10496.doi.org/10.1021/acs.jmedchem.3c00600.28. Mehrotra S, Sano Y, Halkowycz P, et al. Pharmacological characterization of zasocitinib (TAK-279): an oral, highly selective and potent allosteric TYK2 inhibitor. J Invest Dermatol. 2026;146:214-222.e7. https://www.jidonline.org/action/showPdf?pii=S0022-202X%2825%2900531-7. 29. Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. August 21, 2024. JAMA Dermatol. 2024 August 21;160;(10):1066- 1074. doi:10.1001/jamadermatol.2024.2701.30. Shang L, et al. TYK2 in immune responses and treatment of psoriasis. J Inflamm Res. 2022;15:5373-5385. 2022 Sep 16. doi:10.2147/JIR.S38068.31. Krueger JG, McInnes IB, Blauvelt A. Tyrosine Kinase 2 and Janus Kinase‒Signal Transducer and Activator of Transcription Signaling and Inhibition in Plaque Psoriasis. J Am Acad Dermatol. 2022;86(1):148-157. doi:10.1016/j.jaad.2021.06.869.32. A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-Severe Plaque Psoriasis During 52 Weeks of Treatment. ClinicalTrials.gov Identifier: NCT06088043. Updated October 24, 2025. Accessed March 2026. https://clinicaltrials.gov/study/NCT06088043. 33. A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period. ClinicalTrials.gov Identifier: NCT06108544. Updated November 11, 2025. Accessed March 2026. https://clinicaltrials.gov/study/NCT06108544. 34. Martin G. Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors. Dermatol Ther (Heidelb). 2023;13(2):417-435. doi:10.1007/s13555-022-00878-9.35. Danese S, Peyrin-Biroulet L. Selective Tyrosine Kinase 2 Inhibition for Treatment of Inflammatory Bowel Disease: New Hope on the Rise. Inflamm Bowel Dis. 2021;27(12):2023-2030. doi: 10.1093/ibd/izab135.

2026-07-27

·FierceBiotech

InnoCare’s oral TYK2 inhibitor clears phase 3 psoriasis test

InnoCare Pharma announced Monday that its oral tyrosine kinase 2 (TYK2) inhibitor fadeucravacitinib met the primary endpoint in a phase 3 trial of adults with moderate-to-severe plaque psoriasis. The study demonstrated that fadeucravacitinib, also known as ICP-488, produced a clinically meaningful improvement, while multiple secondary endpoints were also met, according to the release . InnoCare said the drug demonstrated a favorable safety profile but did not disclose detailed efficacy or safety data. The randomized, double-blind phase 3 study evaluated the safety and efficacy of fadeucravacitinib compared with placebo in Chinese adults with moderate-to-severe plaque psoriasis. In October 2024, the Beijing-based biopharmaceutical company reported positive phase 2 results , with 77.3% and 78.6% of patients in two dose groups achieving at least a 75% improvement on the Psoriasis Area and Severity Index at week 12, compared with 11.6% of patients who received placebo. The response rates were in the range of results previously reported for Bristol Myers Squibb’s approved oral TYK2 inhibitor Sotyktu, although the drugs have not been compared in a head-to-head trial. Moderate-to-severe plaque psoriasis is a chronic, immune-mediated condition characterized by plaques on the skin. Globally, psoriasis affects 125 million people, including approximately 8.66 million people in China, according to the release. “Existing treatment options do not fully address the needs of psoriasis patients and there is a particularly high demand for novel oral therapies,” InnoCare CEO and co-founder Jasmine Cui, Ph.D., said in the release. “We will work to complete the Phase III study and plan to advance the regulatory filing to bring better treatment options to patients with psoriasis and other autoimmune diseases.” Fadeucravacitinib is an oral, potent and selective TYK2 inhibitor that blocks signaling by inflammatory cytokines including IL-23, IL-12 and type 1 interferon. The drug targets the same signaling pathway as Takeda’s zasocitinib and BMS’ Sotyktu. Takeda recently reported that zasocitinib beat Sotyktu’s active ingredient, deucravacitinib, across the primary and key secondary endpoints of a head-to-head phase 3 trial. Takeda has also reported secondary endpoint results from two other late-stage studies of patients with moderate-to-severe plaque psoriasis, including measures of clearance in hard-to-treat areas such as the scalp, palms and soles of the feet. The trials compared zasocitinib with placebo and Amgen’s Otezla. In the two studies, 42% and 30% of patients treated with zasocitinib achieved clear or almost clear skin in certain hard-to-treat areas by week 16. InnoCare plans to complete the ongoing phase 3 study, including its long-term safety follow-up, before advancing a regulatory filing. Detailed efficacy and safety data are expected to be published or presented at an upcoming scientific meeting.

临床结果临床3期临床2期

2026-07-27

·科学战银

百款银屑病新药蓄力爆发！90余家药企布局，未来3～5年有望集中上市

前言： 2026年4月，DelveInsight 发布《2026 年银屑病管线洞察》报告，梳理了全球银屑病处于各研发阶段的疗法。按照报告统计，纳入临床前与各阶段临床项目一并计算，目前全球有90余家企业布局银屑病新药，在研品种超100个，类型覆盖口服小分子、生物制剂、双功能抗体等多条创新方向。结合当前研发进度来看，未来 3～5 年，银屑病很可能迎来一波新药集中申报与获批。本文结合这份行业报告以及近期公开临床资讯做一次汇总，方便银屑病患者直观了解正在推进中的各类治疗方案。管线核心数据根据 DelveInsight 的报告：布局银屑病新药研发企业 90余家；处于不同临床阶段的在研药物 100+ 个；已进入II期、III期中后期的新药约40余款；九十多家药企竞相开发银屑病治疗方案，足以说明该疾病庞大的患者群体，以及临床上依旧存在大量未被满足的治疗需求。其中四十余款新药已经推进至 II 期或 III 期阶段，按照现有推进节奏，未来3-5年，临床上可供选择的银屑病治疗药物会明显增多。代表性在研药物报告收录接近百款在研品种，下面挑选机制、临床进度各不相同的几款新药，简单梳理最新动态。从给药方式来看，上述在研新药中，处于III期阶段的均为口服剂型，II期两个中也有口服选项。口服药物在中后期管线中占比明显提升，且已有多款口服药物开展头对头对照研究，探索不同口服方案之间的疗效差异。回想五年前，中重度银屑病系统治疗基本依靠进口注射生物制剂。最近两年，多款国产生物制剂陆续拿到上市批件，注射类药物的国产竞争已经全面铺开。靶点层面同样越来越丰富。除大家熟知的 IL‑17、IL‑23 经典通路之外，A3 受体、TYK2、PDE4、巨噬细胞调控、FcγRIIB×PD‑1 双特异性抗体等全新机制项目陆续进入临床。多样化靶点布局，有机会适配不同疗效反应的患者，提供更多个体化选择。近期新药进展安慰剂组第16周转用Icotrokinra、氘可来昔替尼组第24周转用Icotrokinra的患者，各项指标到第52周的时候，全都追到了跟一直吃Icotrokinra的患者差不多的水平。 2026年7月 Can-Fite BioPharma 公布，口服腺苷 A3 受体激动剂 Piclidenoson 关键 III 期研究，完成期中分析所需 247 例受试者入组。期中数据预计在 2026 年第四季度至 2027 年一季度公布，试验整体计划入组约 705 人，研究方案同时获得 FDA 与 EMA 认可。 2026年7月武田在 2026 AAD 学术大会披露 zasocitinib 两项关键 III 期次要终点结果。早在 6 月，该药物与氘可来昔替尼头对头 III 期试验就已经拿到阳性顶线数据。作为新一代高选择性口服 TYK2 抑制剂，适应症瞄准成人中重度斑块状银屑病。武田计划从本财年开始，向 FDA 等药监机构递交上市申请。 2026年6月华海药业旗下华奥泰，IL‑17A 单抗 HB0017 银屑病适应症上市申请正式被 NMPA 受理。 2026年5月海思科 PDE4 抑制剂 HSK44459 乳膏取得 NMPA 临床试验默示许可，即将开展银屑病、特应性皮炎相关临床试验，I/II 期工作已经启动。同一分子的片剂制剂，银屑病适应症目前处在 II 期阶段。 2026年4月 Oruka Therapeutics 对外公布长效 IL‑23p19 单抗 ORKA‑001 IIa 期 16 周临床数据：63.5% 受试者实现 PASI 100，83% 达到 PASI 90，84% 实现 IGA 0/1，药物半衰期大约 100 天。药代动力学结果支持一年 1～2 次给药的潜力，如果后续研究持续稳住当前疗效与安全性，有望开辟全新长效注射方案。 2026年3月 Alumis Inc. 在 2026 AAD 年会口头报告，发布口服 TYK2 抑制剂 envudeucitinib 两项 III 期 ONWARD1、ONWARD2 的 24 周完整数据，企业计划 2026 下半年向 FDA 提交 NDA 上市申请。 2026年2月诺诚健华 ICP‑488（TYK2 抑制剂）银屑病 III 期研究完成全部 383 例患者入组；针对皮肤型红斑狼疮的 II 期试验同步开展。 2026年2月国际银屑病协会联合会（IFPA）和 WHO 基金会签订长期合作协议，合力提升全球银屑病的疾病认知、早期诊断与规范化管理水平。 2026年1月 Oruka Therapeutics 启动 ORKA‑001 IIb 期 EVERLAST‑B 剂量探索试验，计划招募约 160 名受试者。同期公布另一款长效管线 ORKA‑002（IL‑17A/F 双抗）I 期中期数据，半衰期 75～80 天，具备一年两次给药的潜力。 2025年12月武田发布 zasocitinib 两项关键 III 期（LATITUDE PsO 3001、3002）阳性顶线结果。16 周时大约 70% 受试者达到 sPGA 0/1，早在第 4 周，PASI 75 应答就显著优于安慰剂，为每日一次口服方案，用于中重度斑块状银屑病。行业里几个值得留意的变化口服药物、长效制剂，正在重塑长期治疗模式过去很长一段时间，银屑病生物制剂普遍给药间隔较短。当前在研新药分化出两大方向：一类是以 TYK2 抑制剂为代表的口服小分子，持续冲击疗效上限，不用打针，日常维持更为方便；另一类就是 ORKA‑001 这类长效生物制剂，依靠超长半衰期拉长给药间隔，有机会实现一年仅注射 1～2 次。口服与长效注射两条路线并行推进，银屑病长期管理方式很可能迎来改变。新药靶点持续拓宽候选药物覆盖腺苷 A3 受体、TYK2、PDE4、巨噬细胞调节、FcγRIIB×PD‑1 双特异性抗体等多种新颖机制。机制不断丰富，不同类型患者，未来更容易找到匹配自身情况的治疗方案。国内药企研发势头加快华海药业、诺诚健华、海思科、恒瑞医药等多家本土企业，多条银屑病管线进入临床中后期，部分品种已经提交上市申请或开展 III 期试验，国内创新药布局节奏持续提速。对于银写给银屑病病友往后3～5 年，预计会有多款新药陆续获批上市；口服方案、长效注射制剂不断涌现，靶点选择更加多元，整体治疗可选范围持续扩容。想要参与相关临床试用药，可以在本公众号回复关键词：【银屑病】。九十多家药企持续投入银屑病领域研发，足以说明临床需求依旧巨大。可以预见，银屑病整体治疗格局，即将迎来一轮明显扩容。感谢阅读，希望内容能对你有所帮助！参考文献 [1] The Psoriasis Clinical Trial Pipeline Boom as 90+ Companies are in the Race for Better Treatments | DelveInsight.April 14, 2026. 本文内容仅供参考，不构成医疗建议或药物推广宣传；药品疗效存在个体差异，请勿自行用药，如有不适请就医咨询。药品数据源于官方公开信息，仅供客观分享，部分图片及素材来自网络，侵删。 END

100 项与扎索替尼相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
银屑病关节炎	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	保加利亚	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	智利	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	克罗地亚	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	爱沙尼亚	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	德国	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	以色列	Takeda Pharmaceutical Co., Ltd.	2025-03-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04999839 (Pubmed \| Dermatol Ther (Heidelb))	临床2期	斑块状银屑病	151	Zasocitinib 30 mg	醖醖蓋繭蓋觸遞鹹鹹鹽(壓遞鏇膚願艱蓋製鑰壓) = 構願糧鏇窪艱願網淵鬱糧淵夢衊餘遞積製積構 (鏇醖鏇選糧簾壓簾襯襯 )	积极	2026-05-16
				Placebo	衊顧願簾蓋醖糧夢鏇鹹(製壓觸選餘齋憲廠選願) = 鹹夢製襯範糧遞衊鑰網憲簾觸網壓鏇憲餘壓蓋 (鏇獵鏇醖選顧製獵鹽顧 )
NCT04999839 (AAD2026)	临床2期	斑块状银屑病 IL-23 \| type I IFN pathway signaling	62	Zasocitinib 15mg QD	夢範憲蓋醖糧製夢選網(餘遞獵廠鏇鑰繭鹽淵製) = 鹹範糧網鑰齋齋鹽鹹築鏇鏇艱齋憲艱醖鹽鹽獵 (遞夢獵構齋膚簾觸網鬱 )	积极	2026-03-27
NCT05153148 (EULAR2025)	临床2期	银屑病关节炎	290	ZASOCITINIB 15mg	鑰淵築積鹽襯襯齋窪夢(觸齋觸網窪鏇蓋窪鹽膚) = 獵蓋鹽繭膚壓窪鹽夢醖艱觸獵膚窪築鹽簾齋繭 (廠簾選鏇鬱齋鏇簾積艱 )	积极	2025-06-11
				ZASOCITINIB 30mg	鑰淵築積鹽襯襯齋窪夢(觸齋觸網窪鏇蓋窪鹽膚) = 憲繭襯顧襯餘窪糧鬱淵艱觸獵膚窪築鹽簾齋繭 (廠簾選鏇鬱齋鏇簾積艱 )
NCT05153148 (EULAR2025)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	鬱膚壓築製獵醖觸餘醖(憲壓壓遞窪鏇鬱襯糧窪) = Among ACR20 responders, zasocitinib-treated patients generally exhibited dose-dependent reductions from baseline in IL-6, VEGF-A, CCL8 and TWEAK at both Weeks 4 and 12. Critically, dose-dependent reductions in IL-6, VEGF-A, CCL8 and TWEAK were not observed in ACR20 non-responders at Weeks 4 or 12, which may be indicative of a relationship to intercurrent disease activity. Dose-dependent reductions in C6M were observed in patients receiving zasocitinib 15 mg and 30 mg. 顧憲觸憲鹹遞鏇獵鬱齋 (網蓋遞淵顧鹹壓繭壓獵 )	积极	2025-06-11
				Zasocitinib 30 mg
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	-	积极	2024-11-10
				Zasocitinib 30 mg
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	衊鏇繭餘鹹艱鹹積構廠(夢觸鑰憲鏇網觸顧構衊) = 鹽鑰衊齋憲遞範糧鏇獵齋齋獵膚鹽築選蓋衊襯 (齋遞夢蓋夢製願夢醖鏇 )	积极	2024-11-10
				Zasocitinib 30 mg	衊鏇繭餘鹹艱鹹積構廠(夢觸鑰憲鏇網觸顧構衊) = 築觸鬱醖糧鏇鬱夢淵鏇齋齋獵膚鹽築選蓋衊襯 (齋遞夢蓋夢製願夢醖鏇 )
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Placebo	蓋顧願鑰醖衊鑰觸繭齋(築襯糧範鹹壓選淵獵糧) = 醖範繭獵糧獵餘壓築遞壓獵鹹積鑰網餘鑰觸夢 (遞築獵淵艱願鬱鹹蓋觸 )	积极	2024-11-10
				Zasocitinib 5mg	觸衊醖觸襯壓壓襯願衊(餘積構膚獵齋遞膚鏇鹹) = 餘夢鬱繭觸齋簾齋觸遞糧顧積鏇窪壓壓選製鑰 (簾製構鹹鹹築簾窪齋艱 )
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	糧繭選繭鬱窪選鏇積醖(鑰襯蓋鹽蓋觸餘繭範壓) = 餘窪鏇壓鏇繭鏇顧簾廠餘淵鹹廠製蓋鬱範鑰簾 (窪襯製壓願蓋鹹憲顧鹽 )	积极	2024-11-10
				Zasocitinib 30 mg	糧繭選繭鬱窪選鏇積醖(鑰襯蓋鹽蓋觸餘繭範壓) = 鹽願窪範廠範醖糧簾選餘淵鹹廠製蓋鬱範鑰簾 (窪襯製壓願蓋鹹憲顧鹽 ) 更多
NCT04999839 (Pubmed \| JAMA Dermatol) 人工标引	临床2期	斑块状银屑病	259	Zasocitinib 2 mg	簾糧構簾齋憲獵獵觸製(鹹網簾範構壓壓壓蓋構) = 選遞遞艱觸繭衊衊餘願製積艱顧窪鏇淵糧獵觸 (網遞艱遞範衊膚餘範範 )	积极	2024-10-01
				Zasocitinib 5 mg	簾糧構簾齋憲獵獵觸製(鹹網簾範構壓壓壓蓋構) = 選構製鏇廠艱衊鏇鹽壓製積艱顧窪鏇淵糧獵觸 (網遞艱遞範衊膚餘範範 )
NCT05153148 (CTgov)	临床2期	银屑病关节炎	305	Placebo (Placebo)	膚選築構醖鏇簾餘鏇蓋 = 鑰夢窪網壓製齋艱遞艱襯願繭餘糧壓獵網鏇糧 (膚膚獵艱餘鬱憲獵顧網, 鹹積選範觸壓廠築網遞 ~ 選簾遞繭鏇鬱餘壓獵壓) 更多	-	2024-05-31
				NDI-034858 (NDI-034858 Low Dose)	膚選築構醖鏇簾餘鏇蓋 = 膚廠築齋製網襯顧網觸襯願繭餘糧壓獵網鏇糧 (膚膚獵艱餘鬱憲獵顧網, 範製鑰鏇醖鏇構鹹醖齋 ~ 顧築壓餘餘觸製齋獵選) 更多