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一项为期 32 周的试验，旨在评估 Tralokinumab 对适合全身治疗的中度至重度特应性手部湿疹受试者的疗效和安全性 (ADHAND)

2026年7月30日更新者：LEO Pharma

一项 3b 期介入性、适应性临床试验，旨在评估 Tralokinumab 300 mg 每两周一次单药治疗与安慰剂相比，在适合全身治疗的中重度特应性手部湿疹受试者中的疗效和安全性

本研究的目的是测试曲洛金单抗治疗中度至重度特应性手部湿疹是否安全有效。这将通过一系列评估来判断，这些评估评估特应性手部湿疹及其症状的严重程度和范围，以及一般健康状况和生活质量。

审判将持续长达 40 周。最多将进行 15 次访问，其中 3 次将通过电话进行。试验的第一部分称为筛选期，将持续长达 4 周。在筛选后的前 16 周内，试验参与者将每两周接受一次 tralokinumab 或假注射。前 16 周后，所有试验参与者将每两周接受一次 tralokinumab 注射，持续 16 周。试验的最后部分是治疗期结束后 4 周的时间，试验参与者停止用药以进行安全随访。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

235

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- - Québec、加拿大、G1W 4R4
    - LEO Pharma Investigational Site
  - Québec、加拿大、G1V 4X7
    - LEO Pharma Investigational Site
- Alberta
  - Calgary、Alberta、加拿大、T3E 0B2
    - LEO Pharma Investigational Site
  - Edmonton、Alberta、加拿大、T5J 3S9
    - LEO Pharma Investigational Site
  - Edmonton、Alberta、加拿大、T6X 0N9
    - LEO Pharma Investigational Site
  - Red Deer、Alberta、加拿大、T4P 1K4
    - LEO Pharma Investigational Site
- British Columbia
  - Surrey、British Columbia、加拿大、V3R 6A7
    - LEO Pharma Investigational Site
- New Brunswick
  - Fredericton、New Brunswick、加拿大、E3B 1G9
    - LEO Pharma Investigational Site
- Ontario
  - Hamilton、Ontario、加拿大、L8L 3C3
    - LEO Pharma Investigational Site
  - Richmond Hill、Ontario、加拿大、L4B 1A5
    - LEO Pharma Investigational Site
  - Toronto、Ontario、加拿大、M2N 3A6
    - LEO Pharma Investigational Site
  - Windsor、Ontario、加拿大、N8T 1E6
    - LEO Pharma Investigational Site
- Quebec
  - Saint-Jérôme、Quebec、加拿大、J7Z 7E2
    - LEO Pharma Investigational Site
德国
- - Bretzenheim、德国、55128
    - LEO Investigational Site
  - Frankfurt am Main、德国、60590
    - LEO Pharma Investigational Site
  - Haßfurt、德国、97437
    - LEO Pharma Investigational Site
  - Osnabrück、德国、49074
    - LEO Pharma Investigational Site
  - Tübingen、德国、72076
    - LEO Pharma Investigational Site
  - Wuppertal、德国、42283
    - LEO Pharma Investigational Site
比利时
- - Brussels、比利时、1200
    - LEO Pharma Investigational Site
  - Edegem、比利时、2650
    - LEO Pharma Investigational Site
  - Ghent、比利时、9000
    - LEO Pharma Investigational Site
法国
- - Nantes、法国、44093
    - LEO Pharma Investigational Site
  - Pierre-Bénite、法国、69495
    - LEO Pharma Investigational Site
  - Rouen、法国、76031
    - LEO Pharma Investigational Site
波兰
- - Gdansk、波兰、80-462
    - LEO Pharma Investigational Site
  - Krakow、波兰、30-033
    - LEO Pharma Investigational Site
  - Krakow、波兰、31-011
    - LEO Pharma Investigational Site
美国
- Alabama
  - Birmingham、Alabama、美国、35209
    - LEO Pharma Investigational Site
- Arkansas
  - Fort Smith、Arkansas、美国、72916
    - LEO Pharma Investigational Site
- California
  - Fountain Valley、California、美国、92708
    - LEO Pharma Investigational Site
  - Los Angeles、California、美国、90025
    - LEO Pharma Investigational Site
  - Sacramento、California、美国、95816
    - LEO Pharma Investigational Site
- Connecticut
  - Farmington、Connecticut、美国、06032
    - LEO Pharma Investigational Site
- Florida
  - Hialeah、Florida、美国、33012
    - LEO Pharma Investigational Site
- Indiana
  - Plainfield、Indiana、美国、46168
    - LEO Pharma Investigational Site
- Kentucky
  - Louisville、Kentucky、美国、40217
    - LEO Pharma Investigational Site
- Louisiana
  - New Orleans、Louisiana、美国、70115
    - LEO Pharma Investigational Site
- Maine
  - Bangor、Maine、美国、04401
    - LEO Pharma Investigational Site
- Michigan
  - Caledonia、Michigan、美国、49316
    - LEO Pharma Investigational Site
  - Detroit、Michigan、美国、48202
    - LEO Pharma Investigational Site
- New Hampshire
  - Portsmouth、New Hampshire、美国、03801
    - LEO Pharma Investigational Site
- New York
  - Cortland、New York、美国、13045
    - LEO Pharma Investigational Site
  - New York、New York、美国、10075
    - LEO Pharma Investigational Site
- Oregon
  - Portland、Oregon、美国、97210
    - LEO Pharma Investigational Site
  - Portland、Oregon、美国、97201
    - LEO Pharma Investigational Site
- Tennessee
  - Nashville、Tennessee、美国、37211
    - LEO Pharma Investigational Site
- Texas
  - Dallas、Texas、美国、75225
    - LEO Pharma Investigational Site
  - Frisco、Texas、美国、75034
    - LEO Pharma Investigational Site
  - San Antonio、Texas、美国、78213
    - LEO Pharma Investigational Site
  - Webster、Texas、美国、77598
    - LEO Pharma Investigational Site
英国
- - London、英国、SE1 7EH
    - LEO Pharma Investigational Site
- Greater Manchester
  - Salford、Greater Manchester、英国、M6 8HD
    - LEO Pharma Investigational Site
- North Yorkshire
  - Middlesbrough、North Yorkshire、英国、TS4 3BW
    - LEO Pharma Investigational Site
荷兰
- - Amsterdam、荷兰、1105 AZ
    - LEO Pharma Investigational Site
  - Groningen、荷兰、9713 GZ
    - LEO Pharma Investigational Site
西班牙
- - Alicante、西班牙、03010
    - LEO Pharma Investigational Site
  - Barcelona、西班牙、08916
    - LEO Pharma Investigational Site
  - Granada、西班牙、18016
    - LEO Pharma Investigational Site
- Barcelona
  - Badalona、Barcelona、西班牙、08916
    - LEO Pharma Investigational Site
韩国
- - Daegu、韩国、41944
    - LEO Pharma Investigational Site
  - Seoul、韩国、03080
    - LEO Pharma Investigational Site
  - Seoul、韩国、04763
    - LEO Pharma Investigational Site
  - Seoul、韩国、05030
    - LEO Pharma Investigational Site
  - Seoul、韩国、05278
    - LEO Pharma Investigational Site
  - Seoul、韩国、4564
    - LEO Pharma Investigational Site
- Gangwon-do
  - Wŏnju、Gangwon-do、韩国、26426
    - LEO Pharma Investigational Site
- Gyeonggi-do
  - Ansan-si、Gyeonggi-do、韩国、15355
    - LEO Pharma Investigational Site
- Gyeongsangnam-do
  - Yangsan、Gyeongsangnam-do、韩国、05278
    - LEO Pharma Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

纳入标准：

筛选时年满 18 岁或以上
根据 Hanifin 和 Rajka (1980) AD 标准诊断特应性皮炎 (AD)
AD病史≥1年
存在特应性手部湿疹 (AHE)，持续时间超过 3 个月或在过去 12 个月内复发两次或以上，且避免任何已知和相关的刺激物和过敏原
筛查时除手和手腕外，至少有一个身体部位出现 AD 受累
筛查和基线时研究者的总体评估 AHE 评分为 3 或 4（中度至重度）
基线时 HESD 瘙痒评分（每周平均）≥4
有记录的近期病史（筛选访视前 12 个月内）对局部处方药治疗 AHE 反应不足的受试者，或在医学上不建议局部治疗的受试者（例如，由于重要的副作用或安全风险）

排除标准：

如果受试者患有 AHE 以外的活动性手部湿疹亚型（被认为是当前手部湿疹的主要原因），则不得参加试验，包括：
- 活动性刺激性接触性皮炎
- 活动性过敏性接触性皮炎
- 活性蛋白接触性皮炎/接触性荨麻疹
- 活动性角化过度手部湿疹
- 活动性水疱性手部湿疹（汗疱疹）
活动性皮肤病可能会混淆 AD 或 AHE 的诊断，或者会干扰治疗评估
在基线前 28 天内对手或手腕使用晒黑床或光疗（例如 UVB、UVA1、PUVA）或 Grenz 射线疗法，或在基线前 7 天内对手或手腕使用漂白浴
基线前 28 天内使用全身性免疫抑制/免疫调节药物和/或全身性皮质类固醇治疗
基线前 7 天内使用局部皮质类固醇、局部钙调神经磷酸酶抑制剂、局部磷酸二酯酶 4 抑制剂或局部 Janus 激酶抑制剂治疗
收到任何市售生物疗法（即基线前 3 至 6 个月使用免疫球蛋白、抗免疫球蛋白 E)，包括 dupilumab 或研究性生物制剂

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：曲洛单抗 Tralokinumab 给药 32 周（16 周双盲期 + 16 周开放标签期）	药品：曲洛单抗在基线时皮下 (s.c.) 给予 600 mg 的负荷剂量后，试验参与者每两周接受 300 mg 的剂量，持续 32 周
安慰剂比较：安慰剂 + 曲洛单抗安慰剂给药 16 周（双盲期），然后转入 16 周开放标签期，其中给予 tralokinumab	药品：安慰剂在基线时接受皮下负荷剂量 (s.c) 后，试验参与者每两周接受一次安慰剂剂量，持续 16 周

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear) 大体时间：At Week 16	IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	At Week 16

次要结果测量

结果测量	措施说明	大体时间
Percentage of Participants Having a ≥2-point Reduction in IGA-AHE Score 大体时间：From baseline to Week 16	IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	From baseline to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75) 大体时间：From baseline (Day 1) to Week 16	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.	From baseline (Day 1) to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 50% (HECSI-50) 大体时间：From baseline to Week 16	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-50 is defined as at least 50% improvement in HECSI score from baseline.	From baseline to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 90% (HECSI-90) 大体时间：From baseline to Week 16	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.	From baseline to Week 16
Percentage Change in HECSI Score 大体时间：From baseline to Week 16	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity.	From baseline to Week 16
Percentage of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points 大体时间：From baseline to Week 16	The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.	From baseline to Week 16
Percentage Change in HESD Itch Score (Weekly Average) 大体时间：From baseline to Week 16	The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.	From baseline to Week 16
Percentage of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points 大体时间：From baseline to Week 16	The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.	From baseline to Week 16
Percentage Change in HESD Pain Score (Weekly Average) 大体时间：From baseline to Week 16	The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.	From baseline to Week 16
Percentage Change in HEIS Score 大体时间：From baseline to Week 16	HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities: embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.	From baseline to Week 16
Percentage Change in DLQI Score 大体时间：From baseline to Week 16	The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.	From baseline to Week 16
Change in WPAI+CIQ:AHE Domain Scores 大体时间：From baseline to Week 16	The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.	From baseline to Week 16
Number of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear) 大体时间：At Week 32	The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	At Week 32
Number of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75) 大体时间：From baseline to Week 32	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score ranges from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.	From baseline to Week 32
Number of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points 大体时间：From baseline to Week 32	The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.	From baseline to Week 32
Number of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points 大体时间：From baseline to Week 32	The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.	From baseline to Week 32
Percentage Change in HEIS Score 大体时间：From baseline to Week 32	HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities: embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.	From baseline to Week 32
Percentage Change in DLQI Score 大体时间：From baseline to Week 32	The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.	From baseline to Week 32
Change in WPAI+CIQ:AHE Domain Scores 大体时间：From baseline to Week 32	The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.	From baseline to Week 32
Number of Treatment-emergent Adverse Events 大体时间：From baseline to Week 16	An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.	From baseline to Week 16
Number of Treatment-emergent Adverse Events During the Open-label Treatment Period 大体时间：Week 16 to Week 32	An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.	Week 16 to Week 32

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

LEO Pharma

调查人员

研究主任：Medical Expert、LEO Pharma

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年8月28日

初级完成 (实际的)

2025年5月5日

研究完成 (实际的)

2025年9月22日

研究注册日期

首次提交

2023年7月13日

首先提交符合 QC 标准的

2023年7月13日

首次发布 (实际的)

2023年7月24日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

一项为期 32 周的试验，旨在评估 Tralokinumab 对适合全身治疗的中度至重度特应性手部湿疹受试者的疗效和安全性 (ADHAND)

一项 3b 期介入性、适应性临床试验，旨在评估 Tralokinumab 300 mg 每两周一次单药治疗与安慰剂相比，在适合全身治疗的中重度特应性手部湿疹受试者中的疗效和安全性

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

IPD 共享访问标准

IPD 共享支持信息类型

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品