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中等度から重度のアトピー性皮膚炎の成人参加者におけるGSK1070806の安全性と有効性を調査するための用量設定研究 (AtDventure)

2026年5月7日 更新者：GlaxoSmithKline

中等度から重度のアトピー性皮膚炎の成人参加者におけるGSK1070806皮下注射の有効性、安全性、薬物動態および薬力学を評価するための第2b相、無作為化、二重盲検、並行群、プラセボ対照、用量設定研究

この研究は、以前に薬用局所治療または薬物治療を受けた中等度から重度のアトピー性皮膚炎（AtD）の成人参加者を対象としたGSK1070806の有効性、安全性、薬物動態および薬力学を評価するための並行群間プラセボ対照用量範囲研究です。生物学的療法。

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

161

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85006
        • GSK Investigational Site
    • Arkansas
      • North Little Rock、Arkansas、アメリカ、72117
        • GSK Investigational Site
    • California
      • Canoga Park、California、アメリカ、91303
        • GSK Investigational Site
      • Fountain Valley、California、アメリカ、92708
        • GSK Investigational Site
      • Northridge、California、アメリカ、91325
        • GSK Investigational Site
      • Oceanside、California、アメリカ、92056
        • GSK Investigational Site
      • Santa Monica、California、アメリカ、90404
        • GSK Investigational Site
    • Florida
      • Homestead、Florida、アメリカ、33033
        • GSK Investigational Site
      • Oakland Park、Florida、アメリカ、33334
        • GSK Investigational Site
    • Georgia
      • Fayetteville、Georgia、アメリカ、30214
        • GSK Investigational Site
      • Thomasville、Georgia、アメリカ、31792
        • GSK Investigational Site
    • Illinois
      • Chicago、Illinois、アメリカ、60614
        • GSK Investigational Site
    • Michigan
      • Troy、Michigan、アメリカ、48084
        • GSK Investigational Site
    • New York
      • New York、New York、アメリカ、10029
        • GSK Investigational Site
      • New York、New York、アメリカ、10075
        • GSK Investigational Site
    • Ohio
      • Dublin、Ohio、アメリカ、43016
        • GSK Investigational Site
    • Texas
      • West Lake Hills、Texas、アメリカ、78746
        • GSK Investigational Site
  • アルゼンチン
      • Buenos Aires、アルゼンチン、C1055AAO
        • GSK Investigational Site
      • Capital Federal、アルゼンチン、C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno、アルゼンチン、C1056ABI
        • GSK Investigational Site
      • Córdoba、アルゼンチン、X5000AAW
        • GSK Investigational Site
      • Mendoza、アルゼンチン、5500
        • GSK Investigational Site
      • Rosario、アルゼンチン、S2002
        • GSK Investigational Site
  • イタリア
      • Bari、イタリア、70124
        • GSK Investigational Site
      • Bologna、イタリア、40138
        • GSK Investigational Site
      • Florence、イタリア
        • GSK Investigational Site
      • Modena、イタリア、41124
        • GSK Investigational Site
      • Roma、イタリア、00168
        • GSK Investigational Site
      • Roma、イタリア、00128
        • GSK Investigational Site
  • カナダ
    • British Columbia
      • Kelowna、British Columbia、カナダ、V1Y 4N7
        • GSK Investigational Site
    • Ontario
      • Barrie、Ontario、カナダ、L4M 7G1
        • GSK Investigational Site
      • London、Ontario、カナダ、N6H 5L5
        • GSK Investigational Site
      • Markham、Ontario、カナダ、L3P1X2
        • GSK Investigational Site
    • Quebec
      • Québec、Quebec、カナダ、G1W 4R4
        • GSK Investigational Site
  • ギリシャ
      • Athens、ギリシャ
        • GSK Investigational Site
  • スペイン
      • Alicante、スペイン、03010
        • GSK Investigational Site
      • Córdoba、スペイン、14004
        • GSK Investigational Site
      • Granada、スペイン、18016
        • GSK Investigational Site
      • Madrid、スペイン、28222
        • GSK Investigational Site
      • Vigo、スペイン、36206
        • GSK Investigational Site
      • Zaragoza、スペイン、50009
        • GSK Investigational Site
  • タイ
      • Bangkok、タイ、10330
        • GSK Investigational Site
      • Pathum Thani、タイ、12120
        • GSK Investigational Site
  • チェコ
      • Prague、チェコ、10034
        • GSK Investigational Site
      • Prague、チェコ
        • GSK Investigational Site
      • Prague、チェコ、128 08
        • GSK Investigational Site
  • ドイツ
      • Berlin、ドイツ、10789
        • GSK Investigational Site
      • Hamburg、ドイツ、22391
        • GSK Investigational Site
      • Münster、ドイツ、48149
        • GSK Investigational Site
  • パナマ
      • Panama City、パナマ、7099
        • GSK Investigational Site
  • フランス
      • La Rochelle、フランス、17019
        • GSK Investigational Site
      • Paris、フランス、75475
        • GSK Investigational Site
  • ブルガリア
      • Pleven、ブルガリア、5800
        • GSK Investigational Site
      • Sofia、ブルガリア
        • GSK Investigational Site
      • Sofia、ブルガリア、1510
        • GSK Investigational Site
  • ポーランド
      • Chojnice、ポーランド、89-600
        • GSK Investigational Site
      • Elblag、ポーランド、82-300
        • GSK Investigational Site
      • Katowice、ポーランド、40-600
        • GSK Investigational Site
      • Poznan、ポーランド、60-569
        • GSK Investigational Site
      • Szczecin、ポーランド、70-332
        • GSK Investigational Site
      • Warsaw、ポーランド、03-291
        • GSK Investigational Site
  • メキシコ
      • Chihuahua City、メキシコ、31000
        • GSK Investigational Site
      • Durango、メキシコ、34000
        • GSK Investigational Site
      • Guadalajara、メキシコ、44628
        • GSK Investigational Site
      • Monterrey、メキシコ、64718
        • GSK Investigational Site
  • 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
  • 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
  • 韓国
      • Ansan、韓国、15355
        • GSK Investigational Site
      • Seoul、韓国、04763
        • GSK Investigational Site
      • Seoul、韓国、03722
        • GSK Investigational Site
      • Seoul、韓国、150-950
        • GSK Investigational Site
      • Seoul、韓国、04564
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • 18歳から75歳までの大人の参加者

  • 参加者:

    • AtD は AAD コンセンサス基準によって定義されます。
    • AtD と診断されてから 1 年以上。
    • IGA スコア ≥3。
    • AtD 体表面積 (BSA) ≧ 10% の関与。
    • EASI スコア ≥16
    • 少なくとも 3 の最大強度に対するベースラインそう痒数値評価スケールの平均スコア。

  • 参加者は、以下の条件のうち少なくとも 1 つを満たす 1 つの生物学的療法にさらされた可能性があります。

    • 無反応、部分反応、有効性の喪失により治療を中止した参加者。
    • 不耐症または有害事象により治療を中止した参加者。
    • 費用またはアクセスの喪失のために治療を中止した参加者。
  • -スクリーニング来院前（6か月以内）以内）に局所処方薬の安定した処方に対する反応が不十分だった最近の病歴を持つ参加者。
  • 処方された局所薬の服用が許容されない参加者。
  • 女性による避妊の使用は、臨床研究に参加する人の避妊方法に関する現地の規制と一致する必要があります。

除外基準:

  • スクリーニング来院前の4週間以内、またはスクリーニング来院とベースライン来院の間の任意の時点で、経口またはIVの抗生物質、抗ウイルス薬、抗原虫薬、または抗真菌薬による治療を必要とする慢性または急性感染症。
  • -スクリーニング来院前1週間以内の表在性皮膚感染症、または活動性感染症（局所感染症を含む）、または再発性感染症の病歴（爪床の再発性真菌感染症を除く）
  • スクリーニング来院前6か月以内に寄生虫感染症が既知、既存、または疑われる患者。
  • スクリーニング前3か月以内に症状のある帯状疱疹がある
  • 制御不能な高血圧。
  • -肝疾患の現在または慢性の病歴、または既知の肝臓または胆管の異常。
  • -治験責任医師の判断による、感染が解消したにもかかわらず、または異常に頻繁、再発、または長期にわたる感染にもかかわらず、侵襲性日和見感染症の病歴を含む、既知または疑いのある免疫抑制の病歴。
  • 3年間転移性疾患の証拠がなく切除された皮膚の基底細胞癌または扁平上皮癌を除く、過去5年以内のリンパ腫、白血病、または悪性腫瘍
  • 過去10年以内に乳がんにかかった方。
  • -治験責任医師の意見では、研究手順および/または評価に干渉すると考えられる、心血管疾患、呼吸器疾患、肝臓疾患、腎臓疾患、胃腸疾患、内分泌疾患、血液疾患、神経疾患、または精神疾患を含むがこれらに限定されない重大な医学的疾患の病歴または存在。
  • 過去に経口ヤヌスキナーゼ阻害剤（JAKi）または実験的または承認済みの他のキナーゼ阻害剤で治療を受けている。
  • 経口コルチコステロイドのバーストを必要とする可能性のある制御されていない慢性疾患（例、併存する重度の制御されていない喘息）。
  • -スクリーニング時または研究介入の最初の投与前の3か月以内にB型肝炎表面抗体（HBsAg）またはB型肝炎コア抗体（HBcAb）が存在する。
  • -スクリーニング時または研究介入開始前3か月以内のC型肝炎抗体検査結果が陽性。
  • スクリーニング時または研究介入の最初の投与前の3か月以内のC型肝炎RNA検査結果が陽性。
  • HIV抗体検査陽性。
  • 病歴、検査、および最初のスクリーニング来院時の QuantiFERON 検査陽性を伴う結核検査によって文書化された活動性または潜在性結核の証拠。
  • 妊娠中または授乳中の女性、または研究中に妊娠または授乳を計画している女性。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
薬：プラセボ
プラセボが投与されます。
実験的：GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
薬：GSK1070806
GSK1070806が投与されます。
実験的：GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
薬：GSK1070806
GSK1070806が投与されます。
実験的：GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
薬：GSK1070806
GSK1070806が投与されます。
実験的：GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
薬：GSK1070806
GSK1070806が投与されます。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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

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スポンサー

GlaxoSmithKline

捜査官

  • スタディディレクター：GSK Clinical Trials、GlaxoSmithKline

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年11月16日

一次修了 (実際)

2025年7月23日

研究の完了 (実際)

2025年7月23日

試験登録日

最初に提出

2023年8月11日

QC基準を満たした最初の提出物

2023年8月11日

最初の投稿 (実際)

2023年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月7日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 219538
  • 2023-505414-15-00 (レジストリ識別子：CTIS)

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IPD 共有時間枠

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IPD 共有アクセス基準

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IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
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はい

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いいえ

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いいえ

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