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一项剂量探索研究，旨在调查 GSK1070806 对患有中度至重度特应性皮炎的成人参与者的安全性和有效性 (AtDventure)

2026年5月7日 更新者：GlaxoSmithKline

一项 2b 期、随机、双盲、平行组、安慰剂对照、剂量探索研究，旨在评估 GSK1070806 SC 注射剂对中度至重度特应性皮炎成人参与者的疗效、安全性、药代动力学和药效学

本研究是平行组、安慰剂对照剂量范围研究，旨在评估 GSK1070806 在患有中度至重度特应性皮炎 (AtD) 的成年参与者中的疗效、安全性、药代动力学和药效学，这些参与者之前接受过药物局部治疗或药物治疗。生物疗法。

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

161

阶段

  • 阶段2

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

  • 中国
      • Beijing、中国、100044
        • GSK Investigational Site
      • Chongqing、中国、400016
        • GSK Investigational Site
      • Fuzhou、中国、350014
        • GSK Investigational Site
      • Guangzhou、中国
        • GSK Investigational Site
      • Hangzhou、中国、310006
        • GSK Investigational Site
      • Shanghai、中国、200025
        • GSK Investigational Site
      • Shanghai、中国
        • GSK Investigational Site
      • Yinchuan、中国
        • GSK Investigational Site
      • Yiwu、中国、322000
        • GSK Investigational Site
  • 保加利亚
      • Pleven、保加利亚、5800
        • GSK Investigational Site
      • Sofia、保加利亚
        • GSK Investigational Site
      • Sofia、保加利亚、1510
        • GSK Investigational Site
  • 加拿大
    • British Columbia
      • Kelowna、British Columbia、加拿大、V1Y 4N7
        • GSK Investigational Site
    • Ontario
      • Barrie、Ontario、加拿大、L4M 7G1
        • GSK Investigational Site
      • London、Ontario、加拿大、N6H 5L5
        • GSK Investigational Site
      • Markham、Ontario、加拿大、L3P1X2
        • GSK Investigational Site
    • Quebec
      • Québec、Quebec、加拿大、G1W 4R4
        • GSK Investigational Site
  • 墨西哥
      • Chihuahua City、墨西哥、31000
        • GSK Investigational Site
      • Durango、墨西哥、34000
        • GSK Investigational Site
      • Guadalajara、墨西哥、44628
        • GSK Investigational Site
      • Monterrey、墨西哥、64718
        • GSK Investigational Site
  • 巴拿马
      • Panama City、巴拿马、7099
        • GSK Investigational Site
  • 希腊
      • Athens、希腊
        • GSK Investigational Site
  • 德国
      • Berlin、德国、10789
        • GSK Investigational Site
      • Hamburg、德国、22391
        • GSK Investigational Site
      • Münster、德国、48149
        • GSK Investigational Site
  • 意大利
      • Bari、意大利、70124
        • GSK Investigational Site
      • Bologna、意大利、40138
        • GSK Investigational Site
      • Florence、意大利
        • GSK Investigational Site
      • Modena、意大利、41124
        • GSK Investigational Site
      • Roma、意大利、00168
        • GSK Investigational Site
      • Roma、意大利、00128
        • GSK Investigational Site
  • 捷克语
      • Prague、捷克语、10034
        • GSK Investigational Site
      • Prague、捷克语
        • GSK Investigational Site
      • Prague、捷克语、128 08
        • GSK Investigational Site
  • 日本
      • Chiba、日本、272-0033
        • GSK Investigational Site
      • Fukuoka、日本、812-8582
        • GSK Investigational Site
      • Fukuoka、日本、807-8556
        • GSK Investigational Site
      • Gunma、日本、370-0829
        • GSK Investigational Site
      • Hokkaido、日本、060-0033
        • GSK Investigational Site
      • Hokkaido、日本、080-0013
        • GSK Investigational Site
      • Kanagawa、日本、211-0063
        • GSK Investigational Site
      • Osaka、日本、583-8588
        • GSK Investigational Site
      • Osaka、日本、593-8324
        • GSK Investigational Site
      • Saitama、日本、343-8555
        • GSK Investigational Site
  • 法国
      • La Rochelle、法国、17019
        • GSK Investigational Site
      • Paris、法国、75475
        • GSK Investigational Site
  • 波兰
      • Chojnice、波兰、89-600
        • GSK Investigational Site
      • Elblag、波兰、82-300
        • GSK Investigational Site
      • Katowice、波兰、40-600
        • GSK Investigational Site
      • Poznan、波兰、60-569
        • GSK Investigational Site
      • Szczecin、波兰、70-332
        • GSK Investigational Site
      • Warsaw、波兰、03-291
        • GSK Investigational Site
  • 泰国
      • Bangkok、泰国、10330
        • GSK Investigational Site
      • Pathum Thani、泰国、12120
        • GSK Investigational Site
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85006
        • GSK Investigational Site
    • Arkansas
      • North Little Rock、Arkansas、美国、72117
        • GSK Investigational Site
    • California
      • Canoga Park、California、美国、91303
        • GSK Investigational Site
      • Fountain Valley、California、美国、92708
        • GSK Investigational Site
      • Northridge、California、美国、91325
        • GSK Investigational Site
      • Oceanside、California、美国、92056
        • GSK Investigational Site
      • Santa Monica、California、美国、90404
        • GSK Investigational Site
    • Florida
      • Homestead、Florida、美国、33033
        • GSK Investigational Site
      • Oakland Park、Florida、美国、33334
        • GSK Investigational Site
    • Georgia
      • Fayetteville、Georgia、美国、30214
        • GSK Investigational Site
      • Thomasville、Georgia、美国、31792
        • GSK Investigational Site
    • Illinois
      • Chicago、Illinois、美国、60614
        • GSK Investigational Site
    • Michigan
      • Troy、Michigan、美国、48084
        • GSK Investigational Site
    • New York
      • New York、New York、美国、10029
        • GSK Investigational Site
      • New York、New York、美国、10075
        • GSK Investigational Site
    • Ohio
      • Dublin、Ohio、美国、43016
        • GSK Investigational Site
    • Texas
      • West Lake Hills、Texas、美国、78746
        • GSK Investigational Site
  • 西班牙
      • Alicante、西班牙、03010
        • GSK Investigational Site
      • Córdoba、西班牙、14004
        • GSK Investigational Site
      • Granada、西班牙、18016
        • GSK Investigational Site
      • Madrid、西班牙、28222
        • GSK Investigational Site
      • Vigo、西班牙、36206
        • GSK Investigational Site
      • Zaragoza、西班牙、50009
        • GSK Investigational Site
  • 阿根廷
      • Buenos Aires、阿根廷、C1055AAO
        • GSK Investigational Site
      • Capital Federal、阿根廷、C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno、阿根廷、C1056ABI
        • GSK Investigational Site
      • Córdoba、阿根廷、X5000AAW
        • GSK Investigational Site
      • Mendoza、阿根廷、5500
        • GSK Investigational Site
      • Rosario、阿根廷、S2002
        • GSK Investigational Site
  • 韩国
      • Ansan、韩国、15355
        • GSK Investigational Site
      • Seoul、韩国、04763
        • GSK Investigational Site
      • Seoul、韩国、03722
        • GSK Investigational Site
      • Seoul、韩国、150-950
        • GSK Investigational Site
      • Seoul、韩国、04564
        • GSK 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：

  • 18岁至75岁的成人参与者

  • 参与者：

    • AtD 由 AAD 共识标准定义。
    • 诊断 AtD ≥1 年。
    • IGA 分数≥3。
    • AtD 涉及 ≥10% 体表面积 (BSA)。
    • EASI分数≥16
    • 基线瘙痒数字评定量表最大强度的平均得分至少为 3。

  • 参与者可能已经接受过 1 种生物疗法，且至少满足以下条件之一：

    • 由于无反应、部分反应、疗效丧失而停止治疗的参与者。
    • 因不耐受或不良事件而停止治疗的参与者。
    • 由于费用或无法使用而停止治疗的参与者。
  • 近期在筛选访视前少于或等于（≤6）个月）对处方外用药物的稳定方案反应不足的参与者。
  • 不耐受局部处方药物的参与者。
  • 女性使用的避孕药具应符合当地有关参与临床研究的避孕方法的规定

排除标准：

  • 筛选访视前 4 周内或筛选访视与基线访视之间的任何时间需要口服或静脉注射抗生素、抗病毒药物、抗原虫或抗真菌药物治疗的慢性或急性感染。
  • 筛查前1周内有浅表皮肤感染或活动性感染（包括局部感染），或有反复感染史（不包括甲床反复真菌感染）
  • 筛查访视前 6 个月内已知、已存在或疑似寄生虫感染。
  • 筛查前 3 个月内出现有症状的带状疱疹
  • 未控制的高血压。
  • 目前或长期有肝病史或已知的肝脏或胆道异常。
  • 根据研究者的判断，已知或怀疑有免疫抑制史，包括尽管感染已消退但仍有侵袭性机会性感染史，或异常频繁、反复或长期感染。
  • 淋巴瘤、白血病或过去 5 年内的任何恶性肿瘤，但已切除且 3 年内无转移性疾病证据的皮肤基底细胞癌或鳞状上皮癌除外
  • 过去 10 年内患过乳腺癌。
  • 患有或存在重大疾病，包括但不限于心血管、呼吸系统、肝脏、肾脏、胃肠道、内分泌、血液、神经或精神疾病，研究者认为这些疾病会干扰研究程序和/或评估。
  • 之前接受过任何口服 Janus 激酶抑制剂 (JAKi) 或其他实验性或批准的激酶抑制剂治疗。
  • 可能需要大量口服皮质类固醇的不受控制的慢性疾病，例如并发的严重不受控制的哮喘。
  • 筛选时或首次研究干预剂量前 3 个月内存在乙型肝炎表面抗体 (HBsAg) 或乙型肝炎核心抗体 (HBcAb)。
  • 筛查时或开始研究干预前 3 个月内丙型肝炎抗体检测结果呈阳性。
  • 筛查时或第一剂研究干预前 3 个月内丙型肝炎 RNA 检测结果呈阳性。
  • HIV 抗体检测呈阳性。
  • 通过病史、检查和初次筛查访视时 QuantiFERON 检测呈阳性的结核病检测记录的活动性或潜伏性结核病证据。
  • 孕妇或哺乳期妇女，或计划在研究期间怀孕或哺乳的妇女。

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

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
药品：安慰剂
将给予安慰剂。
实验性的：GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
药品：葛兰素史克1070806
GSK1070806将被管理。
实验性的：GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
药品：葛兰素史克1070806
GSK1070806将被管理。
实验性的：GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
药品：葛兰素史克1070806
GSK1070806将被管理。
实验性的：GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
药品：葛兰素史克1070806
GSK1070806将被管理。

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
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
大体时间：Baseline (Day 1) and Week 16
EASI scoring system is standardized clinical tool for assessment of extent (area) & severity of atopic dermatitis(AtD). Severity of clinical signs of AtD (erythema, induration/papulation, excoriation & lichenification) scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs) on 4-point scale: 0=absent;1=mild;2=moderate;3=severe. EASI area score was based upon % body surface area with AtD in body region:0=0%, 1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score was obtained by multiplying EASI area scores (0-6) with severity scores (0-3) of all 4 body regions; it ranges from 0 to 72, with higher scores= more severe or extensive condition. Baseline=last value/assessment before first dose of study treatment (ST) (Day1) based on date & time of assessment (ToA) & treatment. CFB =post-dose visit (Week 16) value minus Baseline value. Percent CFB was calculated by dividing CFB value by Baseline value and multiplying it by 100.
Baseline (Day 1) and Week 16

次要结果测量

结果测量
措施说明
大体时间
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
大体时间：Baseline (Day 1), Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16
EASI scoring system is standardized clinical tool for assessment of extent (area) & severity of atopic dermatitis(AtD). Severity of clinical signs of AtD (erythema, induration/papulation, excoriation & lichenification) scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs) on 4-point scale: 0=absent;1=mild;2=moderate;3=severe. EASI area score was based upon % body surface area with AtD in body region:0=0%, 1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score was obtained by multiplying EASI area scores (0-6) with severity scores (0-3) of all 4 body regions; it ranges from 0 to 72, with higher scores= more severe or extensive condition. Baseline=last value/assessment before first dose of ST (Day1) based on date & ToA & treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Percent CFB was calculated by dividing CFB value by Baseline value and multiplying it by 100.
Baseline (Day 1), Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16
Number of Participants Who Achieved Reduction of Greater Than or Equal to (>=) 75 Percent (%) in EASI Score From Baseline at Week 16
大体时间：Baseline (Day 1) and Week 16
EASI scoring system is standardized clinical tool for assessment of extent (area) & severity of atopic dermatitis(AtD). Severity of clinical signs of AtD (erythema, induration/papulation, excoriation & lichenification) scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs) on 4-point scale: 0=absent;1=mild;2=moderate;3=severe. EASI area score was based upon % body surface area with AtD in body region:0=0%, 1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score was obtained by multiplying EASI area scores (0-6) with severity scores (0-3) of all 4 body regions; it ranges from 0 to 72, with higher scores= more severe or extensive condition. Baseline was the last value/assessment before first dose of study treatment (Day1) based on date & time of assessment & treatment.
Baseline (Day 1) and Week 16
Number of Participants Who Achieved Investigator's Global Assessment (IGA) Score of 0 or 1 and Had a Reduction of >=2 Points From Baseline at Week 16
大体时间：Baseline (Day 1) and Week 16
The Investigator Global Assessment (IGA) is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis. It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. Higher score indicates high severity of disease. IGA 0/1 responders are participants whose IGA score is 'Clear' (0) or 'Almost Clear' (1) and had a reduction of >=2 points from Baseline at Week 16. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment.
Baseline (Day 1) and Week 16
Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16
大体时间：Baseline (Day -7 to Day -1) and Week 16
PP-NRS is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values were evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch. Baseline was averaged from daily values from Day -7 to Day -1 prior to first dose of study treatment (Day 1); post-dose visit i.e. Week 16 used average of 7 daily values from Days 106 to 112 prior to Week 16 (Day 113). Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose (PD) visit (Week 16) value.
Baseline (Day -7 to Day -1) and Week 16
Number of Participants Who Achieved Reduction of >=4 Points in PP-NRS Score From Baseline at Week 16
大体时间：Baseline (Day -7 to Day -1) and Week 16
PP-NRS is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values were evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch. Baseline was averaged from daily values from Day -7 to Day -1 prior to first dose of study treatment (Day 1); post-dose visit i.e. Week 16 used average of 7 daily values from Days 106 to 112 prior to Week 16 (Day 113).
Baseline (Day -7 to Day -1) and Week 16
Number of Participants Who Achieved Reduction of >=50%, >=90% or 100% in EASI Score From Baseline at Week 16
大体时间：Baseline (Day 1) and Week 16
EASI scoring system is standardized clinical tool for assessment of extent (area) & severity of atopic dermatitis(AtD). Severity of clinical signs of AtD (erythema, induration/papulation, excoriation & lichenification) scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs) on 4-point scale: 0=absent;1=mild;2=moderate;3=severe. EASI area score was based upon % body surface area with AtD in body region:0=0%, 1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score was obtained by multiplying EASI area scores (0-6) with severity scores (0-3) of all 4 body regions; it ranges from 0 to 72, with higher scores= more severe or extensive condition. Baseline was the last value/assessment before first dose of study treatment (Day 1) based on date & time of assessment & treatment.
Baseline (Day 1) and Week 16
Number of Participants Who Achieved Reduction of >=50% or >=75% in Scoring Atopic Dermatitis (SCORAD) Score From Baseline at Week 16
大体时间：Baseline (Day 1) and Week 16
SCORAD was used to standardize the extent and severity of AtD. It consisted of 3 components i.e., A=extent or affected BSA assessed as a % of each defined body area and reported as sum of all areas, with a maximum score of 100%.B=severity of 6 specific symptoms of AtD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0,mild=1,moderate=2, or severe=3 (for a maximum of 18 total points) & C=pruritus (itch) & sleep loss scored by participants on VAS, where "0"=no itch(or no sleeplessness) & "10"=worst imaginable itch(or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), & subjective symptoms (C: 0-20) using the formula: A/5 + 7*B/2+ C. SCORAD total score ranged from 0 to 103, where 0=no disease to 103=severe disease. Higher values of SCORAD=worse outcome.
Baseline (Day 1) and Week 16
Change From Baseline in the Body Surface Area (BSA) at Week 16
大体时间：Baseline (Day 1) and Week 16
The BSA assessment estimates the extent of disease or skin involvement with respect to AtD and is expressed as a percentage of total body surface area. BSA were determined by the Investigator or designee using the participant's palm = 1% rule i.e. the surface area of the participant's palm (including fingers) is approximately 1% of the total BSA. Investigators applied this rule to quickly estimate the percentage of skin affected by AtD without complex calculations (for example- if the affected area equals 10 palms, this corresponded to approximately 10% BSA involvement). Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in the SCORAD Score at Week 16
大体时间：Baseline (Day 1) and Week 16
SCORAD was used to standardize the extent and severity of AtD. It consisted of 3 components i.e., A=extent or affected BSA assessed as a % of each defined body area and reported as sum of all areas, with a maximum score of 100%.B=severity of 6 specific symptoms of AtD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0,mild=1,moderate=2, or severe=3 (for a maximum of 18 total points) & C=pruritus (itch) & sleep loss scored by participants on VAS, where "0"=no itch(or no sleeplessness) & "10"=worst imaginable itch(or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), & subjective symptoms (C: 0-20) using the formula: A/5 + 7*B/2+ C. SCORAD total score ranged from 0 to 103, where 0=no disease to 103=severe disease. Higher values of SCORAD=worse outcome.
Baseline (Day 1) and Week 16
Change From Baseline in Patient Reported Outcomes (PRO) Measure of Skin Pain Numerical Rating Scale (SP-NRS) Score at Week 16
大体时间：Baseline (Day -7 to Day -1) and Week 16
SP-NRS is a patient reported measure assessing worst level of skin pain (in the past 24 hours). The values were evaluated using an 11-point scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. Baseline was averaged from daily values from Day -7 to Day -1 prior to first dose of study treatment (Day 1); post-dose visit i.e. Week 16 used average of 7 daily values from Days 106 to 112 prior to Week 16 (Day 113). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day -7 to Day -1) and Week 16
Change From Baseline in PRO Measure of Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance 8b at Week 16
大体时间：Baseline (Day 1) and Week 16
The PROMIS sleep disturbance 8b is a PRO instrument designed to assess participant's self-reported sleep disturbance for which the recall period is the past 7 days. It measures perceptions of sleep quality, depth, and restoration associated with sleep. It contains 8 questions (hence "8b"), these questions are rated using 5-point verbal rating scale (i.e., 1 = very much to 5 = not at all). These are summed to get a total score which ranges from 8 to 40, with higher scores indicating greater severity of sleep disturbance. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Score at Week 16
大体时间：Baseline (Day 1) and Week 16
The FACIT-Fatigue scale is a short, 13-item measure that assesses participant's self-reported fatigue and its associated impact for daily activities over the past week. The items are rated on a 5-point Likert-type scale: (i.e., 0 = very much to 4 = not at all), where a higher score indicates a better outcome (no fatigue). The total score was derived by summing rating of all 13 items, which ranges from 0 to 52, with 0 being the worst possible score and 52 indicating no fatigue. Higher score indicates an improvement in the participant's health status and decrease in the score indicates worse fatigue/quality of life (QoL). Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16
大体时间：Baseline (Day -7 to Day -1) and Week 16
The BFI is a self-administered questionnaire developed to assess fatigue severity. The BFI has 9 items. BFI- Item 3 assesses the worst level of fatigue during the past 24 hours. Participants report their worst level of fatigue daily, for the previous 24 hours, using a numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). The BFI item 3 score ranges from 0 to 10, higher score indicates worst outcome. Baseline was averaged from daily values from Day -7 to Day -1 prior to first dose of study treatment (Day 1); post-dose visit i.e. Week 16 used average of 7 daily values from Days 106 to 112 prior to Week 16 (Day 113). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day -7 to Day -1) and Week 16
Change From Baseline in PRO Measure of Patient Oriented Eczema Measure (POEM) at Week 16
大体时间：Baseline (Day 1) and Week 16
POEM is a 7-item questionnaire that assesses symptoms of dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping over the last week. Each item is scored from 0 to 4, where 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total score was derived by summing scores of all 7-items. Total score ranges from 0 (absent disease) to 28 (severe disease). Higher score indicates poor QoL. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose (Week 16) visit value.
Baseline (Day 1) and Week 16
Change From Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) Score at Week 16
大体时间：Baseline (Day 1) and Week 16
The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin disease has affected their QoL. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score. The total DLQI score ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impaired quality of life. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in PRO Measure of Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at Week 16
大体时间：Baseline (Day 1) and Week 16
HADS was a validated 14-item self-reported questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale. HADS-A assessed state of generalized anxiety. It comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 (no, not at all) to 3 (yes, definitely), where higher scores indicated more anxiety/depression symptoms. HADS-A total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value. Data of HADS-anxiety subscale score has been presented.
Baseline (Day 1) and Week 16
Change From Baseline in PRO Measure of HADS-Depression Subscale Score at Week 16
大体时间：Baseline (Day 1) and Week 16
HADS was a validated 14-item self-reported questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale. HADS-D assessed state of depression. It comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 (no, not at all) to 3 (yes, definitely), where higher scores indicated more anxiety/depression symptoms. HADS-D total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value. Data of HADS-depression subscale score has been presented.
Baseline (Day 1) and Week 16
Change From Baseline in PRO Measure of Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis (WPAI- AD) at Week 16
大体时间：Baseline (Day 1) and Week 16
The WPAI-AD is a concise,6-item questionnaire that evaluates the impact of atopic dermatitis on both work and daily activities, yielding 4 percentage-based impairment scores, each range from 0 to 100%. Higher values=greater impairment. Calculation of these 4 scores are as follows: 1. Work time missed due to health (Absenteeism) (%)=hours missed due to health divided by (hours missed due to health+hours missed for other reasons+hours actually worked) *100. 2. Impairment while working due to health (Presenteeism) (%)=Question (Q)5 score (from 0 to 10) divided by 10*100. 3. Overall work impairment due to health (%)=Absenteeism+(1-Absenteeism fraction)*Presenteeism. 4. Activity impairment due to health (%)=Q6 score (from 0 to 10) divided by 10*100.Baseline was the last value/assessment before the first dose of study treatment (Day1) based on date and time of the assessment and treatment. CFB was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Number of Participants With Adverse Events (AEs), Serious AE (SAEs), and AEs of Special Interest (AESI)
大体时间：Up to Week 28
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with use of a study intervention, whether or not considered related to study intervention. Any untoward medical occurrence that, at any dose, results in death, Is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes, Is a suspected transmission of any infectious agent via an authorized medicinal product and medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, serious hypersensitivity reactions and injection site reactions.
Up to Week 28
Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze hematology parameter: hemoglobin. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Hematology Parameter: Erythrocytes
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze hematology parameter: erythrocytes. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Hematology Parameter: Hematocrit
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze hematology parameter: hematocrit. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze hematology parameter: Prothrombin International Normalized Ratio. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma-Glutamyl Transferase (GGT)
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze clinical chemical parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma-Glutamyl Transferase (GGT). Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Clinical Chemistry Parameter: Total Bilirubin, Direct Bilirubin, and Creatinine
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze clinical chemical parameters: Total Bilirubin, Direct Bilirubin, and Creatinine. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Chemistry Parameters: Glucose and Urea
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze chemistry parameters: glucose and urea. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Chemistry Parameter: Albumin
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze chemistry parameter: albumin. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate
大体时间：Baseline (Day 1) and Week 16
Blood samples were collected to analyze chemistry parameter: Estimated Glomerular Filtration Rate. Baseline was the last value/assessment before the first dose of study treatment (Day 1) based on date and time of the assessment and treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 16) value.
Baseline (Day 1) and Week 16
Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
大体时间：Up to Week 28
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were albumin, glomerular filtration rate from creatinine adjusted for body surface area, glucose, potassium, sodium, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatinine, gamma glutamyl transferase, activated partial thromboplastin time, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets, prothrombin international normalized ratio, eosinophils, and fibrinogen. Worst case grade increase from Baseline grade was evaluated for all the laboratory tests that were gradable by NCI CTCAE. Data is presented for only those parameters for which participants had worst case >= Grade 3 abnormalities.
Up to Week 28

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

GlaxoSmithKline

调查人员

  • 研究主任：GSK Clinical Trials、GlaxoSmithKline

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11月16日

初级完成 (实际的)

2025年7月23日

研究完成 (实际的)

2025年7月23日

研究注册日期

首次提交

2023年8月11日

首先提交符合 QC 标准的

2023年8月11日

首次发布 (实际的)

2023年8月21日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月7日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 219538
  • 2023-505414-15-00 (注册表标识符：CTIS)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可以通过数据共享门户请求访问匿名的个体患者级数据（IPD）和合格研究的相关研究文件。 有关 GSK 数据共享标准的详细信息，请访问：https://www.gsk.com/en-gb/innovation/Trials/data-transparency/

IPD 共享时间框架

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IPD 共享访问标准

匿名 IPD 会与研究人员共享，这些研究人员的提案已获得独立审查小组的批准，并且在数据共享协议到位后。 最初提供 12 个月的访问期限，但如有合理理由，可延长最多 6 个月。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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