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중등도에서 중증의 아토피 피부염을 가진 성인 참여자를 대상으로 GSK1070806의 안전성 및 유효성을 조사하기 위한 용량 결정 연구 (AtDventure)

2026년 5월 7일 업데이트: GlaxoSmithKline

중등도에서 중증 아토피 피부염이 있는 성인 참가자를 대상으로 GSK1070806 SC 주사의 효능, 안전성, 약동학 및 약력학을 평가하기 위한 2b상, 무작위, 이중 맹검, 병렬 그룹, 위약 대조, 용량 결정 연구

이 연구는 이전에 약용 국소 치료제나 약물 치료를 받은 적이 있는 중등도에서 중증의 아토피성 피부염(AtD) 성인 참가자를 대상으로 GSK1070806의 효능, 안전성, 약동학 및 약력학을 평가하기 위한 병행 그룹, 위약 대조 용량 범위 연구입니다. 생물학적 요법.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

161

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 만 18세~75세 성인 참가자

  • 참가자:

    • AAD 합의 기준에 의해 정의된 AtD.
    • AtD ≥1년의 진단.
    • IGA 점수 ≥3.
    • ≥10% 신체 표면적(BSA)의 AtD 침범.
    • EASI 점수 ≥16
    • 최소 3의 최대 강도에 대한 기준선 소양증 수치 등급 척도 평균 점수.

  • 참가자는 다음 조건 중 하나 이상을 충족하는 1가지 생물학적 요법에 노출되었을 수 있습니다.

    • 무반응, 부분반응, 유효성 상실로 인해 치료를 중단한 참가자.
    • 과민증 또는 AE로 인해 치료를 중단한 참가자.
    • 비용 또는 접근성 상실로 인해 치료를 중단한 참가자.
  • 안정적인 국소 약물 처방에 대한 부적절한 반응의 최근 병력이 스크리닝 방문 전 6개월 이하(≤6)개월인 참가자.
  • 처방된 국소 약물이 허용되지 않는 참가자.
  • 여성의 피임 사용은 임상 연구에 참여하는 피임 방법에 관한 현지 규정과 일치해야 합니다.

제외 기준:

  • 스크리닝 방문 전 4주 이내 또는 스크리닝과 기준선 방문 사이의 아무 때나 경구 또는 IV 항생제, 항바이러스제, 항원충제 또는 항진균제로 치료해야 하는 만성 또는 급성 감염.
  • 스크리닝 방문 전 1주일 이내의 표재성 피부 감염 또는 활동성 감염(국소 감염 포함) 또는 재발성 감염 병력(손발톱 바닥의 재발성 진균 감염 제외)
  • 스크리닝 방문 전 6개월 이내에 알려진, 기존 또는 의심되는 기생충 감염.
  • 스크리닝 전 3개월 이내에 증상이 있는 대상포진
  • 조절되지 않는 고혈압.
  • 간 질환 또는 알려진 간 또는 담도 이상의 현재 또는 만성 병력.
  • 조사자의 판단에 따라 감염 해결에도 불구하고 침습성 기회 감염 또는 비정상적으로 빈번하고 반복적이거나 장기간의 감염 이력을 포함하는 면역 억제의 알려지거나 의심되는 이력.
  • 3년 동안 전이성 질환의 증거 없이 절제된 피부의 기저 세포 또는 편평 상피 암종을 제외한 지난 5년 이내에 림프종, 백혈병 또는 모든 악성 종양
  • 지난 10년 이내의 유방암.
  • 연구자의 의견으로는 연구 절차 및/또는 평가를 방해할 심혈관, 호흡기, 간, 신장, 위장관, 내분비계, 혈액학적, 신경학적 또는 정신 장애를 포함하나 이에 제한되지 않는 중대한 의학적 질병의 병력 또는 존재.
  • 이전에 경구용 야누스 키나제 억제제(JAKi) 또는 기타 키나제 억제제(실험적이거나 승인됨)로 치료받은 적이 있습니다.
  • 경구 코르티코스테로이드의 폭발적 투여가 필요할 수 있는 조절되지 않는 만성 질환(예: 동시 이환 중증 조절되지 않는 천식).
  • B형 간염 표면 항체(HBsAg) 또는 B형 간염 코어 항체(HBcAb)의 존재는 스크리닝 시 또는 연구 중재의 첫 번째 투여 전 3개월 이내에 존재합니다.
  • 스크리닝 시 또는 연구 개입 시작 전 3개월 이내에 양성 C형 간염 항체 검사 결과.
  • 스크리닝 시 또는 연구 개입의 첫 투여 전 3개월 이내에 양성 C형 간염 RNA 테스트 결과.
  • 양성 HIV 항체 검사.
  • 병력, 검사 및 최초 선별 방문 시 QuantiFERON 검사에서 양성인 결핵 검사로 기록된 활동성 또는 잠복성 결핵의 증거.
  • 임신 중이거나 모유 수유 중인 여성, 또는 연구 기간 동안 임신 또는 모유 수유를 계획 중인 여성.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
의약품: 위약
위약이 투여될 것입니다.
실험적: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
의약품: GSK1070806
GSK1070806이 투여됩니다.
실험적: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
의약품: GSK1070806
GSK1070806이 투여됩니다.
실험적: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
의약품: GSK1070806
GSK1070806이 투여됩니다.
실험적: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
의약품: GSK1070806
GSK1070806이 투여됩니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

수사관

  • 연구 책임자: GSK Clinical Trials, GlaxoSmithKline

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 11월 16일

기본 완료 (실제)

2025년 7월 23일

연구 완료 (실제)

2025년 7월 23일

연구 등록 날짜

최초 제출

2023년 8월 11일

QC 기준을 충족하는 최초 제출

2023년 8월 11일

처음 게시됨 (실제)

2023년 8월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 7일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 219538
  • 2023-505414-15-00 (레지스트리 식별자: CTIS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

자격을 갖춘 연구원은 데이터 공유 포털을 통해 적격 연구의 익명화된 개별 환자 수준 데이터(IPD) 및 관련 연구 문서에 대한 액세스를 요청할 수 있습니다. GSK의 데이터 공유 기준에 대한 자세한 내용은 https://www.gsk.com/en-gb/innovation/trials/data-transparency/에서 확인할 수 있습니다.

IPD 공유 기간

익명화된 IPD는 모든 적응증에 걸쳐 승인된 적응증 또는 종료된 자산이 있는 제품 연구에 대한 1차, 주요 2차 및 안전성 결과 발표 후 6개월 이내에 제공됩니다.

IPD 공유 액세스 기준

익명화된 IPD는 데이터 공유 계약이 체결된 후 독립 검토 패널에서 제안을 승인한 연구자들과 공유됩니다. 액세스는 초기 12개월 동안 제공되지만 정당한 경우 최대 6개월까지 연장할 수 있습니다.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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