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Een dosisbepalingsonderzoek om de veiligheid en effectiviteit van GSK1070806 te onderzoeken bij volwassen deelnemers met matige tot ernstige atopische dermatitis (AtDventure)

7 mei 2026 bijgewerkt door: GlaxoSmithKline

Een fase 2b, gerandomiseerde, dubbelblinde, parallelle groep, placebogecontroleerde, dosisbepalingsstudie om de werkzaamheid, veiligheid, farmacokinetiek en farmacodynamiek van GSK1070806 SC-injectie te evalueren bij volwassen deelnemers met matige tot ernstige atopische dermatitis

Deze studie is een placebogecontroleerde studie met parallelle groepen om de werkzaamheid, veiligheid, farmacokinetiek en farmacodynamiek van GSK1070806 te evalueren bij volwassen deelnemers met matige tot ernstige atopische dermatitis (AtD), die eerder zijn behandeld met medicinale topische behandelingen of een biologische therapie.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

161

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, C1055AAO
        • GSK Investigational Site
      • Capital Federal, Argentinië, C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentinië, C1056ABI
        • GSK Investigational Site
      • Córdoba, Argentinië, X5000AAW
        • GSK Investigational Site
      • Mendoza, Argentinië, 5500
        • GSK Investigational Site
      • Rosario, Argentinië, S2002
        • GSK Investigational Site
  • Bulgarije
      • Pleven, Bulgarije, 5800
        • GSK Investigational Site
      • Sofia, Bulgarije
        • GSK Investigational Site
      • Sofia, Bulgarije, 1510
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • GSK Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • GSK Investigational Site
      • London, Ontario, Canada, N6H 5L5
        • GSK Investigational Site
      • Markham, Ontario, Canada, L3P1X2
        • GSK Investigational Site
    • Quebec
      • Québec, Quebec, Canada, G1W 4R4
        • 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
  • Duitsland
      • Berlin, Duitsland, 10789
        • GSK Investigational Site
      • Hamburg, Duitsland, 22391
        • GSK Investigational Site
      • Münster, Duitsland, 48149
        • GSK Investigational Site
  • Frankrijk
      • La Rochelle, Frankrijk, 17019
        • GSK Investigational Site
      • Paris, Frankrijk, 75475
        • GSK Investigational Site
  • Griekenland
      • Athens, Griekenland
        • GSK Investigational Site
  • Italië
      • Bari, Italië, 70124
        • GSK Investigational Site
      • Bologna, Italië, 40138
        • GSK Investigational Site
      • Florence, Italië
        • GSK Investigational Site
      • Modena, Italië, 41124
        • GSK Investigational Site
      • Roma, Italië, 00168
        • GSK Investigational Site
      • Roma, Italië, 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
  • Mexico
      • Chihuahua City, Mexico, 31000
        • GSK Investigational Site
      • Durango, Mexico, 34000
        • GSK Investigational Site
      • Guadalajara, Mexico, 44628
        • GSK Investigational Site
      • Monterrey, Mexico, 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
  • Spanje
      • Alicante, Spanje, 03010
        • GSK Investigational Site
      • Córdoba, Spanje, 14004
        • GSK Investigational Site
      • Granada, Spanje, 18016
        • GSK Investigational Site
      • Madrid, Spanje, 28222
        • GSK Investigational Site
      • Vigo, Spanje, 36206
        • GSK Investigational Site
      • Zaragoza, Spanje, 50009
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • GSK Investigational Site
      • Pathum Thani, Thailand, 12120
        • GSK Investigational Site
  • Tsjechië
      • Prague, Tsjechië, 10034
        • GSK Investigational Site
      • Prague, Tsjechië
        • GSK Investigational Site
      • Prague, Tsjechië, 128 08
        • GSK Investigational Site
  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85006
        • GSK Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, Verenigde Staten, 72117
        • GSK Investigational Site
    • California
      • Canoga Park, California, Verenigde Staten, 91303
        • GSK Investigational Site
      • Fountain Valley, California, Verenigde Staten, 92708
        • GSK Investigational Site
      • Northridge, California, Verenigde Staten, 91325
        • GSK Investigational Site
      • Oceanside, California, Verenigde Staten, 92056
        • GSK Investigational Site
      • Santa Monica, California, Verenigde Staten, 90404
        • GSK Investigational Site
    • Florida
      • Homestead, Florida, Verenigde Staten, 33033
        • GSK Investigational Site
      • Oakland Park, Florida, Verenigde Staten, 33334
        • GSK Investigational Site
    • Georgia
      • Fayetteville, Georgia, Verenigde Staten, 30214
        • GSK Investigational Site
      • Thomasville, Georgia, Verenigde Staten, 31792
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60614
        • GSK Investigational Site
    • Michigan
      • Troy, Michigan, Verenigde Staten, 48084
        • GSK Investigational Site
    • New York
      • New York, New York, Verenigde Staten, 10029
        • GSK Investigational Site
      • New York, New York, Verenigde Staten, 10075
        • GSK Investigational Site
    • Ohio
      • Dublin, Ohio, Verenigde Staten, 43016
        • GSK Investigational Site
    • Texas
      • West Lake Hills, Texas, Verenigde Staten, 78746
        • GSK Investigational Site
  • Zuid -Korea
      • Ansan, Zuid -Korea, 15355
        • GSK Investigational Site
      • Seoul, Zuid -Korea, 04763
        • GSK Investigational Site
      • Seoul, Zuid -Korea, 03722
        • GSK Investigational Site
      • Seoul, Zuid -Korea, 150-950
        • GSK Investigational Site
      • Seoul, Zuid -Korea, 04564
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Volwassen deelnemers van 18 jaar tot 75 jaar

  • deelnemers met:

    • AtD gedefinieerd door de AAD-consensuscriteria.
    • Diagnose van AtD ≥1 jaar.
    • Een IGA-score ≥3.
    • Bij D betrokkenheid van ≥10% lichaamsoppervlak (BSA).
    • EASI-score ≥16
    • Baseline pruritus numerieke beoordelingsschaal gemiddelde score voor maximale intensiteit van ten minste 3.

  • Deelnemers zijn mogelijk blootgesteld aan 1 biologische therapie die aan ten minste 1 van de volgende voorwaarden voldoet:

    • Deelnemers die de behandeling stopten vanwege non-respons, gedeeltelijke respons, verlies van werkzaamheid.
    • Deelnemers die de behandeling stopten vanwege intolerantie of bijwerkingen.
    • Deelnemers die de behandeling hebben stopgezet vanwege kosten of verlies van toegang.
  • Deelnemer met een recente geschiedenis van minder dan of gelijk aan (≤6) maanden voorafgaand aan het screeningsbezoek) van onvoldoende respons op een stabiel regime van voorgeschreven lokale medicatie.
  • Deelnemers voor wie lokale medicatie op recept niet wordt getolereerd.
  • Het gebruik van anticonceptie door vrouwen moet in overeenstemming zijn met de lokale regelgeving met betrekking tot de anticonceptiemethoden voor degenen die deelnemen aan klinische studies

Uitsluitingscriteria:

  • Chronische of acute infectie die behandeling met orale of IV-antibiotica, antivirale middelen, antiprotozoale middelen of antischimmelmiddelen vereist binnen 4 weken vóór het screeningsbezoek of op elk moment tussen de screenings- en basislijnbezoeken.
  • Oppervlakkige huidinfecties binnen 1 week voor het screeningsbezoek of actieve infecties (inclusief lokale infecties), of voorgeschiedenis van recidiverende infecties (exclusief terugkerende schimmelinfecties van het nagelbed)
  • Bekende, reeds bestaande of vermoede parasitaire infectie binnen 6 maanden vóór het screeningsbezoek.
  • Symptomatische herpes zoster binnen 3 maanden voorafgaand aan screening
  • Ongecontroleerde hypertensie.
  • Huidige of chronische voorgeschiedenis van leverziekte of bekende lever- of galafwijkingen.
  • Bekende of vermoede voorgeschiedenis van immunosuppressie, inclusief voorgeschiedenis van invasieve opportunistische infecties ondanks het verdwijnen van de infectie of ongewoon frequente, terugkerende of langdurige infecties, volgens het oordeel van de onderzoeker.
  • Lymfoom, leukemie of een maligniteit in de afgelopen 5 jaar, behalve basaalcelcarcinomen of plaveiselepitheelcarcinomen van de huid die zijn gereseceerd zonder bewijs van gemetastaseerde ziekte gedurende 3 jaar
  • Borstkanker in de afgelopen 10 jaar.
  • Voorgeschiedenis of aanwezigheid van significante medische aandoeningen, waaronder maar niet beperkt tot cardiovasculaire, respiratoire, lever-, nier-, gastro-intestinale, endocriene, hematologische, neurologische of psychiatrische stoornissen die naar de mening van de onderzoeker de onderzoeksprocedures en/of beoordelingen zouden verstoren.
  • Eerder behandeld met een orale Janus Kinase-remmer (JAKi) of andere kinaseremmers, experimenteel of goedgekeurd.
  • Ongecontroleerde chronische ziekte waarvoor uitbarstingen van orale corticosteroïden nodig kunnen zijn, bijv. comorbide ernstige ongecontroleerde astma.
  • Aanwezigheid van Hepatitis B-oppervlakte-antilichaam (HBsAg) of Hepatitis B-kernantilichaam (HBcAb) bij screening of binnen 3 maanden voorafgaand aan de eerste dosis van de onderzoeksinterventie.
  • Positief resultaat van de hepatitis C-antilichaamtest bij screening of binnen 3 maanden voorafgaand aan de start van de onderzoeksinterventie.
  • Positief hepatitis C RNA-testresultaat bij screening of binnen 3 maanden voorafgaand aan de eerste dosis studieinterventie.
  • Positieve HIV-antilichaamtest.
  • Bewijs van actieve of latente tbc zoals gedocumenteerd door medische geschiedenis, onderzoek en tbc-testen met een positieve QuantiFERON-test bij het eerste screeningsbezoek.
  • Zwangere vrouwen of vrouwen die borstvoeding geven, of vrouwen die van plan zijn zwanger te worden of borstvoeding te geven tijdens het onderzoek.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
Geneesmiddel: Placebo
Placebo zal worden toegediend.
Experimenteel: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
Geneesmiddel: GSK1070806
GSK1070806 zal worden toegediend.
Experimenteel: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
Geneesmiddel: GSK1070806
GSK1070806 zal worden toegediend.
Experimenteel: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
Geneesmiddel: GSK1070806
GSK1070806 zal worden toegediend.
Experimenteel: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
Geneesmiddel: GSK1070806
GSK1070806 zal worden toegediend.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Onderzoekers

  • Studie directeur: GSK Clinical Trials, GlaxoSmithKline

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 november 2023

Primaire voltooiing (Werkelijk)

23 juli 2025

Studie voltooiing (Werkelijk)

23 juli 2025

Studieregistratiedata

Eerst ingediend

11 augustus 2023

Eerst ingediend dat voldeed aan de QC-criteria

11 augustus 2023

Eerst geplaatst (Werkelijk)

21 augustus 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 219538
  • 2023-505414-15-00 (Register-ID: CTIS)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Gekwalificeerde onderzoekers kunnen toegang vragen tot geanonimiseerde individuele patiëntgegevens (IPD) en gerelateerde onderzoeksdocumenten van de in aanmerking komende onderzoeken via het Data Sharing Portal. Details over GSK's criteria voor het delen van gegevens zijn te vinden op: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD-tijdsbestek voor delen

Geanonimiseerde IPD zal beschikbaar worden gesteld binnen 6 maanden na publicatie van primaire, belangrijke secundaire en veiligheidsresultaten voor onderzoeken in product met goedgekeurde indicatie(s) of beëindigde activa voor alle indicaties.

IPD-toegangscriteria voor delen

Geanonimiseerde IPD wordt gedeeld met onderzoekers van wie de voorstellen zijn goedgekeurd door een onafhankelijk beoordelingspanel en nadat er een overeenkomst voor het delen van gegevens is gesloten. Toegang wordt verleend voor een initiële periode van 12 maanden, maar indien gerechtvaardigd kan een verlenging worden verleend tot maximaal 6 maanden.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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