古塞奇尤单抗(Guselkumab) - 药物靶点：IL-23p19_在研适应症：活动性中度克罗恩病，活动性重度克罗恩病，活动性中度溃疡性结肠炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Guselkumab (Genetical Recombination)、Guselkumab (genetical recombination) (JAN)、Guselkumab (USAN)

+ [8]

靶点

IL-23p19

作用方式

抑制剂

作用机制

IL-23p19抑制剂(白细胞介素-23亚单位p19抑制剂)

治疗领域

免疫系统疾病感染遗传病与畸形+ [5]

在研适应症

活动性中度克罗恩病活动性重度克罗恩病活动性中度溃疡性结肠炎+ [24]

非在研适应症

腺瘤性结肠息肉病乳糜泻泛发性脓疱型银屑病+ [5]

原研机构

Janssen Global Services LLC

在研机构

Janssen-Cilag International NVJanssen Scientific Affairs LLCJanssen Research & Development LLC

+ [11]

非在研机构-

权益机构

Janssen Pharmaceuticals, Inc.

Celsius Therapeutics, Inc.

MorphoSys AG

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (2017-07-13),

斑块状银屑病

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)、突破性疗法 (中国)、孤儿药 (日本)、临床急需境外新药 (中国)

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结构/序列

Sequence Code 9493545H

来源: *****

Sequence Code 9493571L

来源: *****

关联

115

项与古塞奇尤单抗相关的临床试验

NCT07616687

/ Not yet recruiting临床4期IIT

Optimal Care With Guselkumab In Crohn's Disease

Crohn's disease (CD) is a chronic and destructive inflammatory disease of the gastrointestinal tract characterized by phases of relapse and remission. Tumor necrosis factor (TNF) antagonists, anti-integrins and anti-interleukin (IL) 12/23 are the main therapeutic agents to obtain deep remission and prevent disability. Despite the significant advances these biologics represent in treating inflammatory bowel disease (IBD), many patients experience suboptimal responses, including primary non-response or a loss of effectiveness over time, often leading to treatment discontinuation. For all these medications, a dose-response relationship has been demonstrated and an increase in dose or dosing frequency is recommended. Dose escalation is now an essential therapeutic approach necessary in 30 to 50% of CD patients treated with biologics. This strategy, supported by international guidelines, allows for long-term efficacy to be maintained without compromising safety.
Guselkumab (GUS) is a monoclonal antibody targeting the p19 subunit of IL-23. In a recent phase III trial (GALAXI), GUS demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo and ustekinumab. In the GALAXI phase III program, at least 30% of patients did not achieve clinical response after a 12-week intravenous induction, and almost 20% experienced a loss of response by week 44. In these patients, the benefit of an intensified dose of GUS (200 mg q4w) maintenance remains to be determined to guide clinicians in optimizing its use in clinical practice. The investigator aimed to evaluate the one-year effectiveness of GUS in CD in real-world settings and under optimal conditions allowing dose intensification.

开始日期2026-06-01

申办/合作机构-

NCT07602517

/ Not yet recruitingN/AIIT

GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis

This is an observational study of a prospective cohort of guselkumab-initiating Crohn's Disease (CD) and Ulcerative Colitis (UC) patients to identify new or incident spondyloarthritis. This study will include adult patients aged 18-75 with IBD who are undergoing guselkumab intravenous or subcutaneous induction over a 1-year timeframe.

开始日期2026-05-20

申办/合作机构

NYU Langone Health

[+1]

NCT07448402

/ Not yet recruitingN/AIIT

National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System

The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:
* Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
* What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
* Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.

开始日期2026-05-01

申办/合作机构-

100 项与古塞奇尤单抗相关的临床结果

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100 项与古塞奇尤单抗相关的转化医学

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100 项与古塞奇尤单抗相关的专利（医药）

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881

项与古塞奇尤单抗相关的文献（医药）

2026-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

On-label persistence in psoriasis after switching to guselkumab, tumor necrosis factor inhibitors, interleukin-17 inhibitors, or apremilast from other advanced therapies

Article

作者: Zhdanava, Maryia ; Fitzgerald, Timothy ; Feldman, Steven R. ; Boonmak, Porpong ; Schwartzbein, Samuel ; Libchaber, Béatrice ; Pilon, Dominic

OBJECTIVE:

To compare on-label persistence among adults with psoriasis who switched from other advanced therapies to guselkumab versus subcutaneous tumor necrosis factor inhibitors (SC TNFi), subcutaneous interleukin-17 inhibitors (SC IL-17i), or apremilast.

MATERIALS AND METHODS:

This retrospective cohort study used U.S. claims data from the IQVIA PharMetrics® Plus database (2016- 2023). Overlap propensity score weights were used to balance cohorts on baseline characteristics. On-label persistence was defined as the absence of drug discontinuation (event) and any dose change relative to the U.S. label (censoring). Survival analyses were used to assess on-label persistence from the start of the maintenance phase.

RESULTS:

At 12, 18, and 24 months after the start of the maintenance phase, respectively, on-label persistence was 190%, 180%, and 179% more likely on guselkumab versus SC TNFi; 78%, 87%, and 91% more likely on guselkumab versus SC IL-17i; and 187%, 199%, and 193% more likely on guselkumab versus apremilast (all p < 0.001).

CONCLUSIONS:

Patients experiencing suboptimal outcomes with other psoriasis-indicated advanced therapies achieved higher on-label persistence after switching to guselkumab, raising the potential for improved disease control relative to other treatment options.

2026-05-01·ANNALS OF THE RHEUMATIC DISEASES

Thresholds for efficacy outcomes in psoriatic arthritis vary according to baseline disease activity but not according to prior tumour necrosis factor inhibitor treatment

Article

作者: Rampakakis, Emmanouil ; Gossec, Laure ; Ogdie, Alexis ; Adamson, Elizabeth ; Lozenski, Karissa ; Mease, Philip J ; Marzo-Ortega, Helena ; Sharaf, Mohamed

OBJECTIVES:

Efficacy thresholds allow interpretation of randomised clinical trials (RCTs) and establishment of treatment targets. To assess the need for more personalised treatment goals, minimal clinically important improvement (MCII) thresholds in psoriatic arthritis (PsA) clinical and patient-reported outcome measures were determined by treatment history and baseline disease activity.

METHODS:

This post hoc analysis pooled data from 3 RCTs in participants with active PsA receiving guselkumab every 8 week (Q8W), or placebo with W24 transition to guselkumab Q8W. MCII thresholds for clinical Disease Activity Index for PsA (cDAPSA), PsA Disease Activity Score (PASDAS), and patient-reported assessments of arthritis and psoriasis, pain, fatigue, and physical function were determined using established distribution-based methods in participant subgroups defined by prior tumour necrosis factor inhibitor (TNFi) treatment and baseline cDAPSA and PASDAS disease activity (high vs moderate).

RESULTS:

In this pooled RCT population, estimated MCII thresholds for all examined measures were consistent across TNFi-experienced and biologic-naïve cohorts. However, the determined cDAPSA, but not PASDAS, MCII was more stringent among participants with high vs moderate baseline disease activity. Guselkumab-treated participants had greater odds of achieving MCII thresholds vs placebo as early as W8, irrespective of prior TNFi and baseline cDAPSA and PASDAS disease activity, supporting the known-groups validity of the estimated thresholds.

CONCLUSIONS:

Estimated MCII thresholds were consistent regardless of prior TNFi but greater for participants with higher baseline joint disease activity, indicating disease severity may impact perceived PsA improvement. These findings may aid in setting more personalised goals in shared decision‑making and treat-to-target strategies, and RCT interpretation.

2026-05-01·INFLAMMATORY BOWEL DISEASES

Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial.

Article

作者: Vetter, Marion L ; Van Rampelbergh, Rian ; Andrews, Jane M ; Corbett, Christopher ; Panaccione, Remo ; Sands, Bruce E ; Panés, Julián ; Terry, Nat A ; Afzali, Anita ; Salese, Leonardo ; van Duijnhoven, Wilbert ; Yee, Jacqueline ; Hisamatsu, Tadakazu ; Reinisch, Walter ; D'Haens, Geert R ; Danese, Silvio ; Rubin, David T

BACKGROUND:

The randomized, phase 2 GALAXI 1 study evaluated efficacy and safety of guselkumab, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn's disease. Efficacy and safety through 5 years are reported.

METHODS:

After completing the 48-week, treat-through GALAXI 1 main study, participants could enter the long-term extension (LTE) and continue the subcutaneous maintenance regimen assigned at randomization. Efficacy for the combined guselkumab dose groups was analyzed by (1) as-observed analysis of LTE participants, (2) nonresponder imputation (NRI) analysis of LTE participants, and (3) NRI analysis of primary efficacy analysis set (all [week 0] randomized participants). The study was not designed for statistical comparisons between groups.

RESULTS:

Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants.

CONCLUSIONS:

Long-term guselkumab treatment showed sustained clinical and endoscopic efficacy through week 240. The long-term safety data were consistent with those previously presented in approved indications.

CLINICAL TRIAL REGISTRATION:

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI), NCT03466411, https://clinicaltrials.gov/study/NCT03466411.

1,390

项与古塞奇尤单抗相关的新闻（医药）

2026-06-01

·知乎专栏

银屑病｜2026年生物制剂+口服靶向药：最新价格+医保进展！

伊顿健康导读：银屑病的治疗已经进入靶向治疗时代，生物制剂和小分子药物的应用显著改善了患者的生活质量。我国批准上市并已用于治疗银屑病的生物制剂共6种，包括肿TNF-α抑制剂、IL-12/23抑制剂、IL-23抑制剂、IL-17A抑制剂、IL-17A/F及IL-36抑制剂；小分子口服靶向药包括PDE4抑制剂、JAK1抑制剂、JAK1/3抑制剂TYK2抑制剂4 种药物。药物的价格和医保进展几乎是每个中重度银屑病患者关心的，本文将现已在中国获批上市的生物制剂和小分子靶向药的用法用量、价格、医保进展做了汇总，供病友们参考。银屑病生物制剂IL-17A抑制剂用法用量+价格这类药起效快，对中重度斑块状银屑病效果好。司库奇尤单抗（可善挺）：第0、1、2、3、4周，每次2支，之后每月2支维持。目前每支约778.65元，第1年大概32支。已进医保。依奇珠单抗（拓咨）：首次注射2支，第2、4、6、8、10、12周各1支，然后1支/每月维持。每支约1218元，首年约16支。已进医保。赛立奇单抗（金立希）：第0、2、4、6、8、10、12周每次2支，以后2支/每个月维持。每支756元，首年约32支。已纳入医保。夫那奇珠单抗（安达静）：第0、2、4周每次2支，以后2支/每月维持。743.5元/支。第1年共需28支。已纳入医保。安沐奇塔单抗（益赛拓）：有两种用药方案，第一种第0周2支，2/4/6/8/10/12周每次1支，以后1支/4周维持。第二种首次给药2支，4//8/12周每次2支，以后2支/8周维持；一般推荐第二种用药方案。1520元/支，暂未纳入医保，但药企有推出援助活动。夫那奇珠单抗（安达静）：第0、2、4周每次2支，以后2支/每月维持。743.5元/支。第1年共需28支。已纳入医保。布罗利尤单抗（立美芙）：第0周一支，从第2周开始，每2周1支维持。约3000-5000元/支，暂未纳入医保。IL-23抑制剂用法用量+价格这类药维持期打针间隔长，更加方便。古塞奇尤单抗（特诺雅）：第0、4周每次1支，从第8周开始，每2个月1支维持。首年7针，3680元/支，已进医保。替瑞奇珠单抗（益路取）：第0、4周每次1支，从第12周开始，每3个月1支维持。首年5针，4360元/针，已进医保。匹康奇拜单抗（信美悦）：第0、4、8周每次2支，第20周开始，以后每3个月1支维持。首年9针，6500元/针，暂未纳入医保，但目前药企有推出援助活动。IL-23/12抑制剂用法用量+价格乌司奴单抗（喜达诺）：首次和第4周各打1支，之后每3个月1支。第一年5支。4015元/支，已进医保。乌司奴单抗（赛乐信）：首次和第4周各打1支，之后每3个月1支。第一年也是5支。3614元/支，已进医保。依若奇单抗（爱达罗）：第0、4周每次1支，以后1支/每3个月维持。首年5支，3830元/支，已进医保。乌司奴单抗（恩益克）：2026年5月22日新上市，暂未纳入医保。TNF-α抑制剂用法用量+价格这是比较经典的一类，特别是阿达木单抗，市面上品牌很多。修美乐（进口原研）：第0周2支，一周后1支，往后每两周1支。1290元/支，已进医保。格乐立、汉达远、安健宁、苏立信（国产）：这些国产生物类似药用法用量相同，价格都在1000元左右，均已进医保，另外也有援助活动。IL-17A/F和IL-36抑制剂用法用量+价格比奇珠单抗（倍捷乐）：每4周一次，每次1支，约2500元/支，暂未纳入医保，但目前有援助活动。佩索利单抗（圣利卓）：是专门针对脓疱型银屑病的生物制剂，26436元/盒，已纳入医保。小分子口服靶向药用法用量+价格对于怕打针或者想口服治疗的患者，小分子靶向药是个新选择。TYK2抑制剂，氘可来昔替尼（颂狄多）：既可以治疗银屑病，又可以治疗银屑病关节炎，每天口服1次， 28片/盒，1484元/盒，已进医保。JAK1抑制剂，乌帕替尼（瑞福）：也是既可以治疗银屑病，又可以治疗银屑病关节炎，每天/1片，28片/盒，1833.44元/和，也已经进入医保。JAK1/3抑制剂：托法替布（尚杰）：主要用于银屑病关节炎，常释剂5mg每日2次；缓释剂11mg每日1次。785.91（（5mg×28片），1999元（11mg×30片），已进医保。PDE4抑制剂，阿普米司特（欧泰乐）：早晚各1次/1片，30mg×60片/盒，约847元/盒，已纳入医保。伊顿健康温馨提示上述药品价格主要参考市场信息，绝大多数主流生物制剂和口服药都已纳入国家医保，没纳入医保的药物，也有相关援助活动，患者实际自费会更低。各地医保报销比例会有差异，具体以当地医保政策为准。治疗银屑病，现在有了很多好武器，虽然依然无法治愈，但皮损清除已经不是问题。尽管如此，银屑病患者在用药前，也应该谨遵医嘱，必要的检查不可少，切勿自行用药。了解这些信息，希望能帮助你和医生一起，制定出更适合你的治疗方案。如今银屑病/强直性脊柱炎领域创新药研发均在飞速发展，银屑病临床项目包括IL-17A抑制剂，IL-23 抑制剂、TYK2 抑制剂、JAK 抑制剂等多个靶点。强直性脊柱炎临床项目包括IL-17A抑制剂、JAK抑制剂等，生物制剂与口服靶向药均有大量临床研究持续推进。感谢阅读，希望内容能对你有所帮助！本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。材料图片等源自网络，侵删。

2026-06-01

·银消帮

银屑病打可善挺生物制剂？等IL-17生物制剂失效，是改换IL-23靶点的还是换同靶点

点击蓝字关注我们导读对于银友们来说，治疗期间最难受的莫过于打生物制剂的时候，一开始明明治疗效果非常不错，可用了半年、一年后，效果就开始慢慢“打折扣”，而这，就是医学上说的继发性失效。这个时候，就需要面临换药的问题，而换药是换同靶点药物还是其他靶点？今日发表在国内权威期刊《Journal of Dermatological Treatment》上的一项临床研究，为银友们治出了方向。首先，先明白什么是换药银屑病生物制剂的“转换治疗”目前主要有两种首先更换同靶点药物，例如银屑病患者原来用 IL-17A 抑制剂（司库奇尤单抗），失效后换成另一种 IL-17A 靶点的银屑病生物制剂（赛立奇单抗）。其次是跨类转换例如银屑病患者原来用的是IL-17A 抑制剂，换成作用机制完全不同的 IL-23 抑制剂（古塞奇尤单抗、替瑞奇珠单抗）。这里要注意一点，换药不是继发性失效的唯一出路。医生可能会先尝试增加剂量、联用免疫抑制剂（如甲氨蝶呤），或帮银友控制体重，实在没办法了，才会考虑换药。同类换药，效果更好、坚持更久此次发布的临床主要是针对银屑病患者现实用药场景，一开始使用 IL-17A 抑制剂后出现继发性失效的银屑病患者，接下来该换什么药比较好。此次研究得出两个结论首先是银屑病用药史越复杂，跨类换药越容易失败如果银屑病患者已经用过 2 种及以上不同机制的生物制剂，此时再更换成 IL-23 抑制剂，治疗失败的风险会显著升高。也就是说银屑病患者在选择换药的时候，可以优先选择同靶点药物，对长期控制病情非常关键。其次是跨类换药，会影响后续疗效我们都知道，IL-23 靶点的银屑病生物制剂起效速度会比 IL-17A 抑制剂稍微慢一些。不少银屑病患者在更换后换药物以后，由于皮损改善速度变慢，就会丧失治疗信心，非常容易失去信心，从而停止治疗。同靶点药，还能有用？看到这，很多银友感到奇怪：都是打 IL-17A 生物制剂，第一个都耐药了，为什么更换同靶点药物还能有效？道理很简单，虽然靶点相同，但是药物的分子结构有着很大的不同。第一个药物失效，可能是因为银屑病患者体内产生了针对这款药物的抗药抗体，或者它结合靶点的能力下降了，但第二款药物由于分子结构不一样，身体识别不出也就能够继续发挥治疗作用了。小结虽然这项临床研究规模较小，且时间较短（只有28周）有着一定局限性，但研究结果对于银屑病患者有一定的临床意义。因此，如果正在使用IL-17A抑制剂，出现继发性失效时，可以先与专业医生进行充分沟通，在听取专业医生的建议后，优先考虑转换另一种IL-17A抑制剂，也许能获得比直接换IL-23抑制剂更好的效果。参考文献： Liu, Y., Hu, K., Duan, Y., Chen, J., Liu, P., Zhou, S., … Kuang, Y. (2025). What is the optimal sequential therapy after secondary IL-17A inhibitor failure in psoriasis: switching to an IL-23 inhibitor or to another IL-17A inhibitor? Journal of Dermatological Treatment, 36(1). 本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。材料图片等源自网络，侵删

2026-06-01

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银屑病招募 | QL2106注射液vs 古塞奇尤单抗，靶向IL-23，从源头阻断炎症，多城三甲医院免费申请中

点击蓝字关注我们 QL2106注射液正是针对这一靶点的创新生物制剂。它的作用机制如下：精准结合并中和IL-23 → 切断炎症信号的源头 → 阻止下游致炎因子（如IL-17）的释放 → 从根源上控制皮损，实现长期缓解。项项目介绍适应症：中重度斑块状银屑病（牛皮癣）用药情况：QL2106注射液 VS 古塞奇尤单抗注射液（特诺雅）项目周期：周期52周，到院访视约14次，免费用药+相关检查+补助5200元，具体以医院知情为准。入选标准 1、年龄≥18周岁 2、确诊为银屑病≥6个月 3、皮损评估符合以下几点：皮损面积≥全身的10%（约10个巴掌大小）皮损严重程度评分≥12分医生整体评分≥3分（中重度） ❌主要排除标准 1、严重的心脑血管疾病 3、其他自身免疫性疾病 4、曾用过任何的生物制剂 8、近3个月内参加过其他临床试验参加城市北京、上海、广州、石家庄、邯郸、邢台、郑州、洛阳、西安、福州、常德、济南、太原、海口、长沙、重庆、南宁、遂宁、常州、盐城、韶关、哈尔滨、沈阳、长治、荆州、成都、合肥、曲靖、蚌埠、宝鸡、无锡、铜陵、杭州、长春、济宁、昆明、柳州、嘉兴、镇江、驻马店提交资料确诊为银屑病≥6个月的病历皮损照片如果您或亲友符合上述条件，希望进一步了解项目详情或报名参与，欢迎留言咨询或私信获取更多信息。咨询报名了解更多注： 🌟本项目为临床研究，最终入选标准由医院评估确认 🌟所有项目均在三甲医院开展，具体启动时间、补助政策等以医院知情为准。关注公众号，解锁更多精彩。 📌 温馨提示：本文信息仅供参考，不构成专业医疗建议或要约。为了您的健康安全，请务必遵循医嘱，合理用药。本公众号内容仅用于分享学习，严禁挪作他用。若发现信息有误，欢迎随时留言反馈，我们将及时处理。

100 项与古塞奇尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10438	古塞奇尤单抗	L04AC16	DB11834

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
活动性中度克罗恩病	中国	Janssen-Cilag International NV	2025-02-20
活动性重度克罗恩病	中国	Janssen-Cilag International NV	2025-02-20
活动性中度溃疡性结肠炎	美国	Janssen Biotech, Inc.	2024-09-11
活动性重度溃疡性结肠炎	美国	Janssen Biotech, Inc.	2024-09-11
手掌和足底脓疱病	日本	Janssen Pharmaceutical KK	2018-11-21
溃疡性结肠炎	韩国	Janssen Korea Ltd.	2018-04-12
克罗恩病	韩国	Janssen Korea Ltd.	2018-04-12
掌跖角化病	韩国	Janssen Korea Ltd.	2018-04-12
红皮病性银屑病	日本	Janssen Pharmaceutical KK	2018-03-23
银屑病	日本	Janssen Pharmaceutical KK	2018-03-23
脓疱型银屑病	日本	Janssen Pharmaceutical KK	2018-03-23
银屑病关节炎	欧盟	Janssen-Cilag International NV	2017-11-10
银屑病关节炎	冰岛	Janssen-Cilag International NV	2017-11-10
银屑病关节炎	列支敦士登	Janssen-Cilag International NV	2017-11-10
银屑病关节炎	挪威	Janssen-Cilag International NV	2017-11-10
斑块状银屑病	美国	Janssen Biotech, Inc.	2017-07-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	申请上市	美国	Johnson & Johnson	2024-12-02
小儿克罗恩病	临床3期	美国	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	日本	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	澳大利亚	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	奥地利	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	比利时	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	巴西	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	加拿大	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	法国	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	以色列	Janssen Research & Development LLC	2024-03-13

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临床结果

适应症

分期

评价

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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


NCT03466411 (GALAXI 1, Pubmed \| Inflamm Bowel Dis)	临床2期	克罗恩病	185	Guselkumab	簾襯願網窪鏇鏇構鬱膚(夢醖糧窪壓憲選憲範觸) = 廠壓襯製夢鑰廠製願簾鹽膚獵鏇壓膚鏇願齋淵 (壓顧衊齋蓋製夢夢鑰獵 ) 更多	积极	2026-05-01
				Guselkumab (LTE participants)	簾襯願網窪鏇鏇構鬱膚(夢醖糧窪壓憲選憲範觸) = 觸簾淵積積蓋構獵繭醖鹽膚獵鏇壓膚鏇願齋淵 (壓顧衊齋蓋製夢夢鑰獵 )
NCT06039189 (SPECTREM, CTgov)	临床3期	斑块状银屑病	338	Placebo+Guselkumab (Group 1: Placebo Followed by Guselkumab 100 mg)	鬱窪蓋鹽窪膚鹹鹽膚觸 = 膚鑰願淵鏇夢鹹憲憲範餘繭膚鹽簾糧選獵積鑰 (醖夢襯選鑰鏇選衊遞鬱, 淵鏇餘網憲艱鑰齋醖膚 ~ 醖齋衊醖鬱膚醖廠膚壓) 更多	-	2026-05-01
				Guselkumab (Group 2: Guselkumab 100 mg)	鬱窪蓋鹽窪膚鹹鹽膚觸 = 鬱築壓簾構獵鏇齋觸網餘繭膚鹽簾糧選獵積鑰 (醖夢襯選鑰鏇選衊遞鬱, 膚鑰獵餘襯餘選範顧餘 ~ 鏇範鬱憲鑰鹹衊鏇顧廠) 更多
NCT05528510 (ASTRO, Pubmed \| Lancet Gastroenterol Hepatol)	临床3期	溃疡性结肠炎	418	Guselkumab 400/100 mg	鬱廠鑰憲積鏇範選鹹觸(築齋鑰蓋製鬱淵選觸窪) = 顧積鑰衊憲蓋網淵製廠獵製獵鹹簾夢鬱顧範鑰 (糧獵願淵鹽窪窪積鑰糧 ) 更多	积极	2026-04-01
				Guselkumab 400/200 mg	鬱廠鑰憲積鏇範選鹹觸(觸襯衊積糧遞網鬱鏇醖) = 積鬱鹹餘鑰獵膚鏇襯窪製膚鬱獵鑰醖糧製醖顧 (選築淵願網糧窪鹽簾積 ) 更多
SPECTREM (AAD2026)	临床3期	斑块状银屑病	338	Guselkumab 100mg	構簾鹹築積膚製壓糧齋(餘構願願網鬱選選簾鏇) = 糧顧遞淵簾衊築鏇顧獵衊壓壓觸廠積製膚襯簾 (膚鏇壓遞築糧選窪鹹齋 ) 更多	积极	2026-03-27
				Placebo	構簾鹹築積膚製壓糧齋(餘構願願網鬱選選簾鏇) = 壓網鑰糧簾餘構淵憲糧衊壓壓觸廠積製膚襯簾 (膚鏇壓遞築糧選窪鹹齋 ) 更多
AAD2026	N/A	银屑病	40	Guselkumab	壓艱網窪鏇選襯網築積(醖獵鬱選齋願獵糧鬱夢) = 淵鑰鏇願繭網衊壓獵壓遞壓衊艱鬱簾壓顧憲鑰 (簾膚醖廠鹹積齋積顧醖 ) 更多	积极	2026-03-27
VOYAGE 1 (AAD2026)	临床3期	斑块状银屑病	643	Guselkumab	網蓋夢獵積夢選顧鹽壓(膚顧蓋網衊網餘繭窪願) = 餘網餘襯夢顧窪鹹蓋醖窪膚網齋糧窪網鬱範鏇 (築窪鹽蓋簾網繭壓鑰積 ) 更多	积极	2026-03-27
VISIBLE (AAD2026)	临床3期	斑块状银屑病	103	Guselkumab 100mg	襯醖網網遞鏇糧簾網顧(衊衊範製範繭願製積鏇) = 網簾廠製齋蓋淵範廠觸願獵鏇糧鏇襯積艱鹹選 (鏇餘構糧積製獵襯淵範 ) 更多	积极	2026-03-27
				Placebo	淵衊簾築窪鹹願襯膚網(觸築鏇顧艱壓襯顧選蓋) = 鑰蓋襯選製襯鑰廠廠製繭衊繭構鏇艱鑰顧願鑰 (餘憲糧願餘膚繭範網鹹 ) 更多
GUIDE (AAD2026)	临床3期	斑块状银屑病	227	Guselkumab re-treatment	鏇鑰蓋鹹壓齋範鹽顧糧(糧衊鹹膚繭鹹遞鑰鏇顧) = 網積範糧觸網遞鏇艱鹹艱艱構膚簾醖膚壓糧簾 (憲齋鏇選鹹襯網網繭範 ) 更多	积极	2026-03-27
APEX (AAD2026)	临床3期	银屑病关节炎	1,120	Guselkumab Q4W	醖構鹽鏇鬱積構觸鏇選(簾鏇鏇選艱廠範獵鏇蓋) = 鏇鬱衊鹽鹽構顧壓餘範餘觸餘積齋觸餘齋膚選 (餘繭願鹽選構窪餘鏇鏇 ) 更多	积极	2026-03-27
				Guselkumab Q8W	醖構鹽鏇鬱積構觸鏇選(簾鏇鏇選艱廠範獵鏇蓋) = 鏇願憲繭獵膚選憲蓋遞餘觸餘積齋觸餘齋膚選 (餘繭願鹽選構窪餘鏇鏇 ) 更多
AAD2026	N/A	银屑病 \| 类风湿关节炎	32	TNF- inhibitors (Systemic treatment)	繭襯襯鬱願獵鏇齋廠鬱(夢顧網積鏇繭鑰齋艱獵) = 鏇襯醖壓範膚鑰積製鏇積鏇範鏇遞壓網衊鏇網 (繭網鬱獵觸選選觸壓襯 )	积极	2026-03-27
				methotrexate (Systemic treatment)	窪遞鹹築襯築積壓遞網(鹹壓鹽憲齋淵繭繭簾窪) = 鏇製觸鏇鹽糧築顧壓蓋蓋糧蓋鹹憲觸繭鏇選糧 (顧範選築廠蓋鏇衊構憲 )