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Eine Dosisfindungsstudie zur Untersuchung der Sicherheit und Wirksamkeit von GSK1070806 bei erwachsenen Teilnehmern mit mittelschwerer bis schwerer atopischer Dermatitis (AtDventure)

7. Mai 2026 aktualisiert von: GlaxoSmithKline

Eine randomisierte, doppelblinde, parallele, placebokontrollierte Dosisfindungsstudie der Phase 2b zur Bewertung der Wirksamkeit, Sicherheit, Pharmakokinetik und Pharmakodynamik der GSK1070806 SC-Injektion bei erwachsenen Teilnehmern mit mittelschwerer bis schwerer atopischer Dermatitis

Bei dieser Studie handelt es sich um eine placebokontrollierte Parallelgruppen-Dosisfindungsstudie zur Bewertung der Wirksamkeit, Sicherheit, Pharmakokinetik und Pharmakodynamik von GSK1070806 bei erwachsenen Teilnehmern mit mittelschwerer bis schwerer atopischer Dermatitis (AtD), die zuvor mit medikamentösen topischen Behandlungen oder a behandelt wurden biologische Therapie.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

161

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Erwachsene Teilnehmer im Alter von 18 bis 75 Jahren

  • Teilnehmer mit:

    • AtD definiert durch die AAD-Konsenskriterien.
    • Diagnose von AtD ≥1 Jahr.
    • Ein IGA-Score ≥3.
    • AtD-Beteiligung von ≥10 % der Körperoberfläche (KOF).
    • EASI-Score ≥16
    • Durchschnittlicher Wert der numerischen Bewertungsskala für Pruritus zu Beginn bei maximaler Intensität von mindestens 3.

  • Die Teilnehmer waren möglicherweise einer biologischen Therapie ausgesetzt, die mindestens eine der folgenden Bedingungen erfüllte:

    • Teilnehmer, die die Behandlung aufgrund von Nichtansprechen, teilweisem Ansprechen oder Wirksamkeitsverlust abgebrochen haben.
    • Teilnehmer, die die Behandlung aufgrund von Unverträglichkeiten oder Nebenwirkungen abgebrochen haben.
    • Teilnehmer, die die Behandlung aufgrund von Kosten oder Zugangsverlust abgebrochen haben.
  • Teilnehmer mit einer aktuellen Vorgeschichte von weniger als oder gleich (≤6) Monaten vor dem Screening-Besuch) mit unzureichendem Ansprechen auf ein stabiles Regime verschreibungspflichtiger topischer Medikamente.
  • Teilnehmer, bei denen verschreibungspflichtige topische Medikamente nicht vertragen werden.
  • Die Anwendung von Verhütungsmitteln durch Frauen sollte im Einklang mit den örtlichen Vorschriften bezüglich der Verhütungsmethoden für die Teilnehmer an klinischen Studien stehen

Ausschlusskriterien:

  • Chronische oder akute Infektion, die eine Behandlung mit oralen oder intravenösen Antibiotika, Virostatika, Protozoenmitteln oder Antimykotika innerhalb von 4 Wochen vor dem Screening-Besuch oder jederzeit zwischen dem Screening- und dem Baseline-Besuch erfordert.
  • Oberflächliche Hautinfektionen innerhalb einer Woche vor dem Screening-Besuch oder aktive Infektionen (einschließlich lokalisierter Infektionen) oder wiederkehrende Infektionen in der Vorgeschichte (ausgenommen wiederkehrende Pilzinfektionen des Nagelbetts)
  • Bekannte, bereits bestehende oder vermutete parasitäre Infektion innerhalb von 6 Monaten vor dem Screening-Besuch.
  • Symptomatischer Herpes Zoster innerhalb von 3 Monaten vor dem Screening
  • Unkontrollierter Bluthochdruck.
  • Aktuelle oder chronische Vorgeschichte einer Lebererkrankung oder bekannte Leber- oder Gallenanomalien.
  • Bekannte oder vermutete Vorgeschichte einer Immunsuppression, einschließlich Vorgeschichte invasiver opportunistischer Infektionen trotz Abklingens der Infektion oder ungewöhnlich häufiger, wiederkehrender oder länger anhaltender Infektionen, nach Einschätzung des Prüfarztes.
  • Lymphom, Leukämie oder andere bösartige Erkrankungen innerhalb der letzten 5 Jahre, mit Ausnahme von Basalzell- oder Plattenepithelkarzinomen der Haut, die 3 Jahre lang ohne Anzeichen einer Metastasierung reseziert wurden
  • Brustkrebs innerhalb der letzten 10 Jahre.
  • Anamnese oder Vorhandensein einer bedeutenden medizinischen Erkrankung, einschließlich, aber nicht beschränkt auf Herz-Kreislauf-, Atemwegs-, Leber-, Nieren-, Magen-Darm-, endokrine, hämatologische, neurologische oder psychiatrische Störungen, die nach Ansicht des Prüfarztes die Studienabläufe und/oder -bewertungen beeinträchtigen würden.
  • Zuvor mit einem oralen Janus-Kinase-Inhibitor (JAKi) oder anderen experimentellen oder zugelassenen Kinase-Inhibitoren behandelt.
  • Unkontrollierte chronische Erkrankung, die möglicherweise Schübe oraler Kortikosteroide erfordert, z. B. komorbides schweres unkontrolliertes Asthma.
  • Vorhandensein von Hepatitis-B-Oberflächenantikörpern (HBsAg) oder Hepatitis-B-Kernantikörpern (HBcAb) beim Screening oder innerhalb von 3 Monaten vor der ersten Dosis der Studienintervention.
  • Positives Hepatitis-C-Antikörpertestergebnis beim Screening oder innerhalb von 3 Monaten vor Beginn der Studienintervention.
  • Positives Hepatitis-C-RNA-Testergebnis beim Screening oder innerhalb von 3 Monaten vor der ersten Dosis der Studienintervention.
  • Positiver HIV-Antikörpertest.
  • Nachweis einer aktiven oder latenten Tuberkulose, dokumentiert durch Anamnese, Untersuchung und Tuberkulosetests mit einem positiven QuantiFERON-Test beim ersten Screening-Besuch.
  • Schwangere oder stillende Frauen oder Frauen, die während der Studie schwanger werden oder stillen möchten.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
Arzneimittel: Placebo
Placebo wird verabreicht.
Experimental: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
Arzneimittel: GSK1070806
GSK1070806 wird verwaltet.
Experimental: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
Arzneimittel: GSK1070806
GSK1070806 wird verwaltet.
Experimental: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
Arzneimittel: GSK1070806
GSK1070806 wird verwaltet.
Experimental: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
Arzneimittel: GSK1070806
GSK1070806 wird verwaltet.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Ermittler

  • Studienleiter: GSK Clinical Trials, GlaxoSmithKline

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. November 2023

Primärer Abschluss (Tatsächlich)

23. Juli 2025

Studienabschluss (Tatsächlich)

23. Juli 2025

Studienanmeldedaten

Zuerst eingereicht

11. August 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. August 2023

Zuerst gepostet (Tatsächlich)

21. August 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 219538
  • 2023-505414-15-00 (Registrierungskennung: CTIS)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualifizierte Forscher können über das Data Sharing Portal Zugriff auf anonymisierte individuelle Patientendaten (IPD) und zugehörige Studiendokumente der förderfähigen Studien beantragen. Einzelheiten zu den Datenfreigabekriterien von GSK finden Sie unter: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD-Sharing-Zeitrahmen

Anonymisierte IPD werden innerhalb von 6 Monaten nach Veröffentlichung der primären, wichtigen sekundären und Sicherheitsergebnisse für Studien zu Produkten mit zugelassener(n) Indikation(en) oder abgekündigten Asset(s) für alle Indikationen zur Verfügung gestellt.

IPD-Sharing-Zugriffskriterien

Anonymisierte IPD werden an Forscher weitergegeben, deren Vorschläge von einem unabhängigen Prüfgremium genehmigt wurden, und nachdem eine Vereinbarung zur Datenfreigabe getroffen wurde. Der Zugang wird zunächst für einen Zeitraum von 12 Monaten gewährt, in begründeten Fällen kann jedoch eine Verlängerung um bis zu 6 Monate gewährt werden.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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