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Badanie mające na celu ustalenie dawki w celu zbadania bezpieczeństwa i skuteczności GSK1070806 u dorosłych uczestników z umiarkowanym do ciężkiego atopowym zapaleniem skóry (AtDventure)

7 maja 2026 zaktualizowane przez: GlaxoSmithKline

Randomizowane, podwójnie ślepe, równoległe badanie fazy 2b, kontrolowane placebo, mające na celu ustalenie dawki w celu oceny skuteczności, bezpieczeństwa, farmakokinetyki i farmakodynamiki GSK1070806 we wstrzyknięciu podskórnym u dorosłych uczestników z atopowym zapaleniem skóry o nasileniu umiarkowanym do ciężkiego

To badanie jest równoległym, kontrolowanym placebo badaniem z zakresem dawek w celu oceny skuteczności, bezpieczeństwa, farmakokinetyki i farmakodynamiki GSK1070806 u dorosłych uczestników z umiarkowanym do ciężkiego atopowym zapaleniem skóry (AtD), którzy byli wcześniej leczeni miejscowymi lekami lub terapia biologiczna.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

161

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, C1055AAO
        • GSK Investigational Site
      • Capital Federal, Argentyna, C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentyna, C1056ABI
        • GSK Investigational Site
      • Córdoba, Argentyna, X5000AAW
        • GSK Investigational Site
      • Mendoza, Argentyna, 5500
        • GSK Investigational Site
      • Rosario, Argentyna, S2002
        • GSK Investigational Site
  • Bułgaria
      • Pleven, Bułgaria, 5800
        • GSK Investigational Site
      • Sofia, Bułgaria
        • GSK Investigational Site
      • Sofia, Bułgaria, 1510
        • GSK Investigational Site
  • Chiny
      • Beijing, Chiny, 100044
        • GSK Investigational Site
      • Chongqing, Chiny, 400016
        • GSK Investigational Site
      • Fuzhou, Chiny, 350014
        • GSK Investigational Site
      • Guangzhou, Chiny
        • GSK Investigational Site
      • Hangzhou, Chiny, 310006
        • GSK Investigational Site
      • Shanghai, Chiny, 200025
        • GSK Investigational Site
      • Shanghai, Chiny
        • GSK Investigational Site
      • Yinchuan, Chiny
        • GSK Investigational Site
      • Yiwu, Chiny, 322000
        • GSK Investigational Site
  • Czechy
      • Prague, Czechy, 10034
        • GSK Investigational Site
      • Prague, Czechy
        • GSK Investigational Site
      • Prague, Czechy, 128 08
        • GSK Investigational Site
  • Francja
      • La Rochelle, Francja, 17019
        • GSK Investigational Site
      • Paris, Francja, 75475
        • GSK Investigational Site
  • Grecja
      • Athens, Grecja
        • GSK Investigational Site
  • Hiszpania
      • Alicante, Hiszpania, 03010
        • GSK Investigational Site
      • Córdoba, Hiszpania, 14004
        • GSK Investigational Site
      • Granada, Hiszpania, 18016
        • GSK Investigational Site
      • Madrid, Hiszpania, 28222
        • GSK Investigational Site
      • Vigo, Hiszpania, 36206
        • GSK Investigational Site
      • Zaragoza, Hiszpania, 50009
        • GSK Investigational Site
  • Japonia
      • Chiba, Japonia, 272-0033
        • GSK Investigational Site
      • Fukuoka, Japonia, 812-8582
        • GSK Investigational Site
      • Fukuoka, Japonia, 807-8556
        • GSK Investigational Site
      • Gunma, Japonia, 370-0829
        • GSK Investigational Site
      • Hokkaido, Japonia, 060-0033
        • GSK Investigational Site
      • Hokkaido, Japonia, 080-0013
        • GSK Investigational Site
      • Kanagawa, Japonia, 211-0063
        • GSK Investigational Site
      • Osaka, Japonia, 583-8588
        • GSK Investigational Site
      • Osaka, Japonia, 593-8324
        • GSK Investigational Site
      • Saitama, Japonia, 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
  • Korea Południowa
      • Ansan, Korea Południowa, 15355
        • GSK Investigational Site
      • Seoul, Korea Południowa, 04763
        • GSK Investigational Site
      • Seoul, Korea Południowa, 03722
        • GSK Investigational Site
      • Seoul, Korea Południowa, 150-950
        • GSK Investigational Site
      • Seoul, Korea Południowa, 04564
        • GSK Investigational Site
  • Meksyk
      • Chihuahua City, Meksyk, 31000
        • GSK Investigational Site
      • Durango, Meksyk, 34000
        • GSK Investigational Site
      • Guadalajara, Meksyk, 44628
        • GSK Investigational Site
      • Monterrey, Meksyk, 64718
        • GSK Investigational Site
  • Niemcy
      • Berlin, Niemcy, 10789
        • GSK Investigational Site
      • Hamburg, Niemcy, 22391
        • GSK Investigational Site
      • Münster, Niemcy, 48149
        • GSK Investigational Site
  • Panama
      • Panama City, Panama, 7099
        • GSK Investigational Site
  • Polska
      • Chojnice, Polska, 89-600
        • GSK Investigational Site
      • Elblag, Polska, 82-300
        • GSK Investigational Site
      • Katowice, Polska, 40-600
        • GSK Investigational Site
      • Poznan, Polska, 60-569
        • GSK Investigational Site
      • Szczecin, Polska, 70-332
        • GSK Investigational Site
      • Warsaw, Polska, 03-291
        • GSK Investigational Site
  • Stany Zjednoczone
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85006
        • GSK Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, Stany Zjednoczone, 72117
        • GSK Investigational Site
    • California
      • Canoga Park, California, Stany Zjednoczone, 91303
        • GSK Investigational Site
      • Fountain Valley, California, Stany Zjednoczone, 92708
        • GSK Investigational Site
      • Northridge, California, Stany Zjednoczone, 91325
        • GSK Investigational Site
      • Oceanside, California, Stany Zjednoczone, 92056
        • GSK Investigational Site
      • Santa Monica, California, Stany Zjednoczone, 90404
        • GSK Investigational Site
    • Florida
      • Homestead, Florida, Stany Zjednoczone, 33033
        • GSK Investigational Site
      • Oakland Park, Florida, Stany Zjednoczone, 33334
        • GSK Investigational Site
    • Georgia
      • Fayetteville, Georgia, Stany Zjednoczone, 30214
        • GSK Investigational Site
      • Thomasville, Georgia, Stany Zjednoczone, 31792
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60614
        • GSK Investigational Site
    • Michigan
      • Troy, Michigan, Stany Zjednoczone, 48084
        • GSK Investigational Site
    • New York
      • New York, New York, Stany Zjednoczone, 10029
        • GSK Investigational Site
      • New York, New York, Stany Zjednoczone, 10075
        • GSK Investigational Site
    • Ohio
      • Dublin, Ohio, Stany Zjednoczone, 43016
        • GSK Investigational Site
    • Texas
      • West Lake Hills, Texas, Stany Zjednoczone, 78746
        • GSK Investigational Site
  • Tajlandia
      • Bangkok, Tajlandia, 10330
        • GSK Investigational Site
      • Pathum Thani, Tajlandia, 12120
        • GSK Investigational Site
  • Włochy
      • Bari, Włochy, 70124
        • GSK Investigational Site
      • Bologna, Włochy, 40138
        • GSK Investigational Site
      • Florence, Włochy
        • GSK Investigational Site
      • Modena, Włochy, 41124
        • GSK Investigational Site
      • Roma, Włochy, 00168
        • GSK Investigational Site
      • Roma, Włochy, 00128
        • GSK Investigational Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Dorośli uczestnicy w wieku od 18 do 75 lat

  • Uczestnicy z:

    • AtD zdefiniowane przez AAD Consensus Criteria.
    • Rozpoznanie AtD ≥1 rok.
    • Wynik IGA ≥3.
    • Zajęcie AtD ≥10% powierzchni ciała (BSA).
    • Wynik EASI ≥16
    • Wyjściowy średni wynik w numerycznej skali oceny świądu dla maksymalnej intensywności co najmniej 3.

  • Uczestnicy mogli mieć kontakt z 1 terapią biologiczną spełniającą co najmniej 1 z następujących warunków:

    • Uczestnicy, którzy przerwali leczenie z powodu braku odpowiedzi, częściowej odpowiedzi, utraty skuteczności.
    • Uczestnicy, którzy przerwali leczenie z powodu nietolerancji lub zdarzeń niepożądanych.
    • Uczestnicy, którzy przerwali leczenie z powodu kosztów lub utraty dostępu.
  • Uczestnik z niedawną historią krótszą lub równą (≤6) miesiącom przed wizytą przesiewową) niewystarczającej odpowiedzi na stały schemat miejscowych leków na receptę.
  • Uczestnicy, u których miejscowe leki na receptę nie są tolerowane.
  • Stosowanie środków antykoncepcyjnych przez kobiety powinno być zgodne z lokalnymi przepisami dotyczącymi metod antykoncepcji dla osób uczestniczących w badaniu klinicznym

Kryteria wyłączenia:

  • Przewlekła lub ostra infekcja wymagająca leczenia doustnymi lub dożylnymi antybiotykami, lekami przeciwwirusowymi, przeciwpierwotniakowymi lub przeciwgrzybiczymi w ciągu 4 tygodni przed wizytą przesiewową lub w dowolnym momencie pomiędzy wizytą przesiewową a wizytą wyjściową.
  • Powierzchowne zakażenia skóry w ciągu 1 tygodnia przed wizytą przesiewową lub czynne zakażenia (w tym zakażenia miejscowe) lub nawracające zakażenia w wywiadzie (z wyłączeniem nawracających zakażeń grzybiczych łożyska paznokcia)
  • Znana, wcześniej istniejąca lub podejrzewana infekcja pasożytnicza w ciągu 6 miesięcy przed wizytą przesiewową.
  • Objawowy półpasiec w ciągu 3 miesięcy przed badaniem przesiewowym
  • Niekontrolowane nadciśnienie.
  • Obecna lub przewlekła historia chorób wątroby lub znanych nieprawidłowości wątroby lub dróg żółciowych.
  • Znana lub podejrzewana immunosupresja w wywiadzie, w tym inwazyjne infekcje oportunistyczne w wywiadzie pomimo ustąpienia infekcji lub niezwykle częste, nawracające lub przedłużające się infekcje, zgodnie z oceną badacza.
  • Chłoniak, białaczka lub jakikolwiek nowotwór złośliwy w ciągu ostatnich 5 lat, z wyjątkiem raka podstawnokomórkowego lub raka płaskonabłonkowego skóry, które zostały usunięte bez objawów przerzutów przez 3 lata
  • Rak piersi w ciągu ostatnich 10 lat.
  • Historia lub obecność poważnych chorób medycznych, w tym między innymi zaburzeń sercowo-naczyniowych, oddechowych, wątrobowych, nerek, żołądkowo-jelitowych, endokrynologicznych, hematologicznych, neurologicznych lub psychiatrycznych, które w opinii badacza mogłyby zakłócać procedury badania i/lub oceny.
  • Wcześniej leczony jakimkolwiek doustnym inhibitorem kinazy janusowej (JAKi) lub innymi inhibitorami kinazy, eksperymentalnymi lub zatwierdzonymi.
  • Niekontrolowana przewlekła choroba, która może wymagać wyrzutów doustnych kortykosteroidów, np. współistniejąca ciężka niekontrolowana astma.
  • Obecność przeciwciał powierzchniowych przeciwko wirusowi zapalenia wątroby typu B (HBsAg) lub przeciwciał przeciwko rdzeniu wirusa zapalenia wątroby typu B (HBcAb) podczas badania przesiewowego lub w ciągu 3 miesięcy przed podaniem pierwszej dawki badanej interwencji.
  • Dodatni wynik testu na obecność przeciwciał przeciwko wirusowemu zapaleniu wątroby typu C podczas badania przesiewowego lub w ciągu 3 miesięcy przed rozpoczęciem interwencji badawczej.
  • Dodatni wynik testu RNA wirusa zapalenia wątroby typu C podczas badania przesiewowego lub w ciągu 3 miesięcy przed podaniem pierwszej dawki badanej interwencji.
  • Pozytywny wynik testu na przeciwciała HIV.
  • Dowody na aktywną lub utajoną gruźlicę udokumentowane wywiadem lekarskim, badaniem i testem na gruźlicę z pozytywnym wynikiem testu QuantiFERON podczas pierwszej wizyty przesiewowej.
  • Kobiety w ciąży lub karmiące piersią lub kobiety planujące zajść w ciążę lub karmiące piersią podczas badania.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
Lek: Placebo
Zostanie podane placebo.
Eksperymentalny: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
Lek: GSK1070806
GSK1070806 zostanie podany.
Eksperymentalny: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
Lek: GSK1070806
GSK1070806 zostanie podany.
Eksperymentalny: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
Lek: GSK1070806
GSK1070806 zostanie podany.
Eksperymentalny: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
Lek: GSK1070806
GSK1070806 zostanie podany.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Śledczy

  • Dyrektor Studium: GSK Clinical Trials, GlaxoSmithKline

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 listopada 2023

Zakończenie podstawowe (Rzeczywisty)

23 lipca 2025

Ukończenie studiów (Rzeczywisty)

23 lipca 2025

Daty rejestracji na studia

Pierwszy przesłany

11 sierpnia 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 sierpnia 2023

Pierwszy wysłany (Rzeczywisty)

21 sierpnia 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 219538
  • 2023-505414-15-00 (Identyfikator rejestru: CTIS)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Wykwalifikowani badacze mogą poprosić o dostęp do anonimowych danych na poziomie poszczególnych pacjentów (IPD) i powiązanych dokumentów badawczych kwalifikujących się badań za pośrednictwem portalu udostępniania danych. Szczegóły dotyczące kryteriów udostępniania danych przez GSK można znaleźć na stronie: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Ramy czasowe udostępniania IPD

Zanonimizowane IChP zostaną udostępnione w ciągu 6 miesięcy od opublikowania wyników pierwszorzędowych, kluczowych drugorzędnych i wyników badań dotyczących bezpieczeństwa dla badań produktu z zatwierdzonym wskazaniem lub składnikami zakończonymi we wszystkich wskazaniach.

Kryteria dostępu do udostępniania IPD

Zanonimizowane IPD są udostępniane naukowcom, których wnioski zostały zatwierdzone przez niezależny zespół recenzentów i po zawarciu umowy o udostępnianiu danych. Dostęp jest udzielany na początkowy okres 12 miesięcy, ale w uzasadnionych przypadkach może zostać przedłużony na okres do 6 miesięcy.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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