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Исследование по подбору дозы для изучения безопасности и эффективности GSK1070806 у взрослых участников с атопическим дерматитом от умеренной до тяжелой степени (AtDventure)

7 мая 2026 г. обновлено: GlaxoSmithKline

Фаза 2b, рандомизированное, двойное слепое, параллельное групповое, плацебо-контролируемое исследование по подбору дозы для оценки эффективности, безопасности, фармакокинетики и фармакодинамики подкожной инъекции GSK1070806 у взрослых участников с атопическим дерматитом от умеренной до тяжелой степени.

Это исследование представляет собой плацебо-контролируемое исследование в параллельных группах с ранжированием доз для оценки эффективности, безопасности, фармакокинетики и фармакодинамики GSK1070806 у взрослых участников с атопическим дерматитом от умеренной до тяжелой степени (АтД), которые ранее получали медикаментозное местное лечение или биологическая терапия.

Обзор исследования

Статус

Прекращено

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

161

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • Взрослые участники от 18 до 75 лет

  • Участники с:

    • AtD определяется критериями консенсуса AAD.
    • Диагноз АтД ≥1 года.
    • Оценка IGA ≥3.
    • Поражение АтД ≥10% площади поверхности тела (ППТ).
    • Оценка EASI ≥16
    • Средний балл исходной числовой шкалы оценки зуда для максимальной интенсивности не менее 3.

  • Участники, возможно, подверглись воздействию 1 биологической терапии, отвечающей по крайней мере 1 из следующих условий:

    • Участники, прекратившие лечение из-за отсутствия ответа, частичного ответа, потери эффективности.
    • Участники, прекратившие лечение из-за непереносимости или нежелательных явлений.
    • Участники, прекратившие лечение из-за стоимости или потери доступа.
  • Участник с недавним анамнезом менее или равного (≤6) месяцам до визита для скрининга) неадекватного ответа на стабильный режим рецептурных препаратов для местного применения.
  • Участники, для которых рецептурные местные лекарства не переносятся.
  • Использование противозачаточных средств женщинами должно соответствовать местным правилам, касающимся методов контрацепции для тех, кто участвует в клиническом исследовании.

Критерий исключения:

  • Хроническая или острая инфекция, требующая лечения пероральными или внутривенными антибиотиками, противовирусными, антипротозойными или противогрибковыми препаратами в течение 4 недель до визита для скрининга или в любое время между визитами для скрининга и исходного уровня.
  • Поверхностные кожные инфекции в течение 1 недели до визита для скрининга или активные инфекции (включая локализованные инфекции) или рецидивирующие инфекции в анамнезе (исключая рецидивирующие грибковые инфекции ногтевого ложа)
  • Известная, ранее существовавшая или подозреваемая паразитарная инфекция в течение 6 месяцев до визита для скрининга.
  • Симптоматический опоясывающий герпес в течение 3 месяцев до скрининга
  • Неконтролируемая артериальная гипертензия.
  • Текущая или хроническая история болезни печени или известные печеночные или желчные аномалии.
  • Известная или подозреваемая история иммуносупрессии, включая историю инвазивных оппортунистических инфекций, несмотря на разрешение инфекции или необычно частые, рецидивирующие или длительные инфекции, по мнению исследователя.
  • Лимфома, лейкемия или любое злокачественное новообразование в течение последних 5 лет, за исключением базально-клеточного или плоскоклеточного рака кожи, которые были резецированы без признаков метастатического заболевания в течение 3 лет.
  • Рак молочной железы в течение последних 10 лет.
  • История или наличие серьезного медицинского заболевания, включая, помимо прочего, сердечно-сосудистые, респираторные, печеночные, почечные, желудочно-кишечные, эндокринные, гематологические, неврологические или психические расстройства, которые, по мнению исследователя, могут помешать процедурам исследования и / или оценкам.
  • Ранее лечился любым пероральным ингибитором янус-киназы (JAKi) или другими ингибиторами киназы, экспериментальными или одобренными.
  • Неконтролируемое хроническое заболевание, которое может потребовать приема пероральных кортикостероидов, например, сопутствующая тяжелая неконтролируемая астма.
  • Наличие поверхностных антител к гепатиту В (HBsAg) или ядерных антител к гепатиту В (HBcAb) при скрининге или в течение 3 месяцев до первой дозы исследуемого вмешательства.
  • Положительный результат теста на антитела к гепатиту С при скрининге или в течение 3 месяцев до начала исследования.
  • Положительный результат теста на РНК гепатита С при скрининге или в течение 3 месяцев до первой дозы исследуемого вмешательства.
  • Положительный тест на антитела к ВИЧ.
  • Доказательства активного или латентного ТБ, подтвержденные анамнезом, обследованием и тестированием на ТБ с положительным тестом QuantiFERON при первом визите для скрининга.
  • Беременные или кормящие женщины, а также женщины, планирующие забеременеть или кормить грудью во время исследования.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
Лекарство: Плацебо
Будет введено плацебо.
Экспериментальный: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
Лекарство: ГСК1070806
GSK1070806 будет администрироваться.
Экспериментальный: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
Лекарство: ГСК1070806
GSK1070806 будет администрироваться.
Экспериментальный: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
Лекарство: ГСК1070806
GSK1070806 будет администрироваться.
Экспериментальный: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
Лекарство: ГСК1070806
GSK1070806 будет администрироваться.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

GlaxoSmithKline

Следователи

  • Директор по исследованиям: GSK Clinical Trials, GlaxoSmithKline

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

16 ноября 2023 г.

Первичное завершение (Действительный)

23 июля 2025 г.

Завершение исследования (Действительный)

23 июля 2025 г.

Даты регистрации исследования

Первый отправленный

11 августа 2023 г.

Впервые представлено, что соответствует критериям контроля качества

11 августа 2023 г.

Первый опубликованный (Действительный)

21 августа 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

7 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 219538
  • 2023-505414-15-00 (Идентификатор реестра: CTIS)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Квалифицированные исследователи могут запросить доступ к анонимным данным на уровне отдельных пациентов (IPD) и связанным с ними исследовательским документам соответствующих исследований через портал обмена данными. Подробную информацию о критериях обмена данными GSK можно найти по адресу: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Сроки обмена IPD

Анонимизированный IPD будет доступен в течение 6 месяцев после публикации первичных, ключевых вторичных результатов и результатов исследований безопасности для исследований продукта с утвержденным(и) показанием(ями) или прекращенным активом(ами) по всем показаниям.

Критерии совместного доступа к IPD

Анонимные IPD передаются исследователям, чьи предложения одобрены независимой экспертной группой и после заключения соглашения об обмене данными. Доступ предоставляется на первоначальный период в 12 месяцев, но может быть предоставлено продление, если это оправдано, на срок до 6 месяцев.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ
  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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