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Studie pro zjištění dávky ke zkoumání bezpečnosti a účinnosti GSK1070806 u dospělých účastníků se středně těžkou až těžkou atopickou dermatitidou (AtDventure)

7. května 2026 aktualizováno: GlaxoSmithKline

Fáze 2b, randomizovaná, dvojitě zaslepená, paralelní skupina, placebem kontrolovaná, studie pro zjištění dávek k vyhodnocení účinnosti, bezpečnosti, farmakokinetiky a farmakodynamiky SC injekce GSK1070806 u dospělých účastníků se středně těžkou až těžkou atopickou dermatitidou

Tato studie je placebem kontrolovaná studie s paralelními skupinami, která hodnotí účinnost, bezpečnost, farmakokinetiku a farmakodynamiku GSK1070806 u dospělých účastníků se středně těžkou až těžkou atopickou dermatitidou (AtD), kteří byli dříve léčeni medikovanou lokální léčbou nebo biologická léčba.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

161

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Argentina
      • Buenos Aires, Argentina, C1055AAO
        • GSK Investigational Site
      • Capital Federal, Argentina, C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1056ABI
        • GSK Investigational Site
      • Córdoba, Argentina, X5000AAW
        • GSK Investigational Site
      • Mendoza, Argentina, 5500
        • GSK Investigational Site
      • Rosario, Argentina, S2002
        • GSK Investigational Site
  • Bulharsko
      • Pleven, Bulharsko, 5800
        • GSK Investigational Site
      • Sofia, Bulharsko
        • GSK Investigational Site
      • Sofia, Bulharsko, 1510
        • GSK Investigational Site
  • Francie
      • La Rochelle, Francie, 17019
        • GSK Investigational Site
      • Paris, Francie, 75475
        • GSK Investigational Site
  • Itálie
      • Bari, Itálie, 70124
        • GSK Investigational Site
      • Bologna, Itálie, 40138
        • GSK Investigational Site
      • Florence, Itálie
        • GSK Investigational Site
      • Modena, Itálie, 41124
        • GSK Investigational Site
      • Roma, Itálie, 00168
        • GSK Investigational Site
      • Roma, Itálie, 00128
        • GSK Investigational Site
  • Japonsko
      • Chiba, Japonsko, 272-0033
        • GSK Investigational Site
      • Fukuoka, Japonsko, 812-8582
        • GSK Investigational Site
      • Fukuoka, Japonsko, 807-8556
        • GSK Investigational Site
      • Gunma, Japonsko, 370-0829
        • GSK Investigational Site
      • Hokkaido, Japonsko, 060-0033
        • GSK Investigational Site
      • Hokkaido, Japonsko, 080-0013
        • GSK Investigational Site
      • Kanagawa, Japonsko, 211-0063
        • GSK Investigational Site
      • Osaka, Japonsko, 583-8588
        • GSK Investigational Site
      • Osaka, Japonsko, 593-8324
        • GSK Investigational Site
      • Saitama, Japonsko, 343-8555
        • GSK Investigational Site
  • Jižní Korea
      • Ansan, Jižní Korea, 15355
        • GSK Investigational Site
      • Seoul, Jižní Korea, 04763
        • GSK Investigational Site
      • Seoul, Jižní Korea, 03722
        • GSK Investigational Site
      • Seoul, Jižní Korea, 150-950
        • GSK Investigational Site
      • Seoul, Jižní Korea, 04564
        • 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
  • Německo
      • Berlin, Německo, 10789
        • GSK Investigational Site
      • Hamburg, Německo, 22391
        • GSK Investigational Site
      • Münster, Německo, 48149
        • GSK Investigational Site
  • Panama
      • Panama City, Panama, 7099
        • GSK Investigational Site
  • Polsko
      • Chojnice, Polsko, 89-600
        • GSK Investigational Site
      • Elblag, Polsko, 82-300
        • GSK Investigational Site
      • Katowice, Polsko, 40-600
        • GSK Investigational Site
      • Poznan, Polsko, 60-569
        • GSK Investigational Site
      • Szczecin, Polsko, 70-332
        • GSK Investigational Site
      • Warsaw, Polsko, 03-291
        • GSK Investigational Site
  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85006
        • GSK Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, Spojené státy, 72117
        • GSK Investigational Site
    • California
      • Canoga Park, California, Spojené státy, 91303
        • GSK Investigational Site
      • Fountain Valley, California, Spojené státy, 92708
        • GSK Investigational Site
      • Northridge, California, Spojené státy, 91325
        • GSK Investigational Site
      • Oceanside, California, Spojené státy, 92056
        • GSK Investigational Site
      • Santa Monica, California, Spojené státy, 90404
        • GSK Investigational Site
    • Florida
      • Homestead, Florida, Spojené státy, 33033
        • GSK Investigational Site
      • Oakland Park, Florida, Spojené státy, 33334
        • GSK Investigational Site
    • Georgia
      • Fayetteville, Georgia, Spojené státy, 30214
        • GSK Investigational Site
      • Thomasville, Georgia, Spojené státy, 31792
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Spojené státy, 60614
        • GSK Investigational Site
    • Michigan
      • Troy, Michigan, Spojené státy, 48084
        • GSK Investigational Site
    • New York
      • New York, New York, Spojené státy, 10029
        • GSK Investigational Site
      • New York, New York, Spojené státy, 10075
        • GSK Investigational Site
    • Ohio
      • Dublin, Ohio, Spojené státy, 43016
        • GSK Investigational Site
    • Texas
      • West Lake Hills, Texas, Spojené státy, 78746
        • GSK Investigational Site
  • Thajsko
      • Bangkok, Thajsko, 10330
        • GSK Investigational Site
      • Pathum Thani, Thajsko, 12120
        • GSK Investigational Site
  • Česko
      • Prague, Česko, 10034
        • GSK Investigational Site
      • Prague, Česko
        • GSK Investigational Site
      • Prague, Česko, 128 08
        • GSK Investigational Site
  • Čína
      • Beijing, Čína, 100044
        • GSK Investigational Site
      • Chongqing, Čína, 400016
        • GSK Investigational Site
      • Fuzhou, Čína, 350014
        • GSK Investigational Site
      • Guangzhou, Čína
        • GSK Investigational Site
      • Hangzhou, Čína, 310006
        • GSK Investigational Site
      • Shanghai, Čína, 200025
        • GSK Investigational Site
      • Shanghai, Čína
        • GSK Investigational Site
      • Yinchuan, Čína
        • GSK Investigational Site
      • Yiwu, Čína, 322000
        • GSK Investigational Site
  • Řecko
      • Athens, Řecko
        • GSK Investigational Site
  • Španělsko
      • Alicante, Španělsko, 03010
        • GSK Investigational Site
      • Córdoba, Španělsko, 14004
        • GSK Investigational Site
      • Granada, Španělsko, 18016
        • GSK Investigational Site
      • Madrid, Španělsko, 28222
        • GSK Investigational Site
      • Vigo, Španělsko, 36206
        • GSK Investigational Site
      • Zaragoza, Španělsko, 50009
        • GSK Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Dospělí účastníci od 18 do 75 let

  • Účastníci s:

    • AtD definované konsensuálními kritérii AAD.
    • Diagnóza AtD ≥1 rok.
    • Skóre IGA ≥3.
    • AtD postižení ≥10 % tělesného povrchu (BSA).
    • EASI skóre ≥16
    • Základní pruritus číselná hodnotící stupnice průměrné skóre pro maximální intenzitu alespoň 3.

  • Účastníci mohli být vystaveni 1 biologické léčbě splňující alespoň 1 z následujících podmínek:

    • Účastníci, kteří ukončili léčbu z důvodu nereagování, částečné odpovědi, ztráty účinnosti.
    • Účastníci, kteří ukončili léčbu kvůli intoleranci nebo nežádoucím účinkům.
    • Účastníci, kteří léčbu ukončili z důvodu nákladů nebo ztráty přístupu.
  • Účastník s nedávnou anamnézou menší nebo rovnou (≤6) měsíců před screeningovou návštěvou) s nedostatečnou odpovědí na stabilní režim lokální medikace na předpis.
  • Účastníci, u kterých nejsou tolerovány lokální léky na předpis.
  • Používání antikoncepce ženami by mělo být v souladu s místními předpisy týkajícími se metod antikoncepce pro účastníky klinické studie

Kritéria vyloučení:

  • Chronická nebo akutní infekce vyžadující léčbu perorálními nebo IV antibiotiky, antivirotiky, antiprotozoálními nebo antimykotiky během 4 týdnů před screeningovou návštěvou nebo kdykoli mezi screeningovou a základní návštěvou.
  • Povrchové kožní infekce během 1 týdne před screeningovou návštěvou nebo aktivní infekce (včetně lokalizovaných infekcí) nebo anamnéza rekurentních infekcí (s výjimkou recidivujících mykotických infekcí nehtového lůžka)
  • Známá, již existující nebo suspektní parazitární infekce během 6 měsíců před screeningovou návštěvou.
  • Symptomatický pásový opar během 3 měsíců před screeningem
  • Nekontrolovaná hypertenze.
  • Současná nebo chronická anamnéza onemocnění jater nebo známých abnormalit jater nebo žlučových cest.
  • Známá nebo suspektní imunosuprese v anamnéze, včetně anamnézy invazivních oportunních infekcí navzdory vyléčení infekce nebo neobvykle častých, opakujících se nebo prodloužených infekcí, podle úsudku zkoušejícího.
  • Lymfom, leukémie nebo jakákoli malignita během posledních 5 let s výjimkou bazaliomů nebo karcinomů dlaždicového epitelu kůže, které byly resekovány bez známek metastatického onemocnění po dobu 3 let
  • Rakovina prsu za posledních 10 let.
  • Anamnéza nebo přítomnost významného zdravotního onemocnění, včetně, ale bez omezení, kardiovaskulárních, respiračních, jaterních, ledvinových, gastrointestinálních, endokrinních, hematologických, neurologických nebo psychiatrických poruch, které by podle názoru zkoušejícího mohly interferovat s postupy studie a/nebo hodnocením.
  • Dříve léčeni jakýmkoli perorálním inhibitorem Janus kinázy (JAKi) nebo jinými inhibitory kinázy, experimentálními nebo schválenými.
  • Nekontrolované chronické onemocnění, které může vyžadovat návaly perorálních kortikosteroidů, např. komorbidní těžké nekontrolované astma.
  • Přítomnost povrchové protilátky proti hepatitidě B (HBsAg) nebo jádrové protilátky proti hepatitidě B (HBcAb) při screeningu nebo během 3 měsíců před první dávkou studijní intervence.
  • Pozitivní výsledek testu na protilátky proti hepatitidě C při screeningu nebo do 3 měsíců před zahájením studijní intervence.
  • Pozitivní výsledek testu RNA na hepatitidu C při screeningu nebo do 3 měsíců před první dávkou studijní intervence.
  • Pozitivní test na HIV protilátky.
  • Důkaz aktivní nebo latentní TBC zdokumentovaný anamnézou, vyšetřením a testováním TBC s pozitivním testem QuantiFERON při úvodní screeningové návštěvě.
  • Těhotné nebo kojící ženy nebo ženy, které plánují otěhotnět nebo kojit během studie.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
Lék: Placebo
Bude podáváno placebo.
Experimentální: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
Lék: GSK1070806
GSK1070806 bude spravován.
Experimentální: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
Lék: GSK1070806
GSK1070806 bude spravován.
Experimentální: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
Lék: GSK1070806
GSK1070806 bude spravován.
Experimentální: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
Lék: GSK1070806
GSK1070806 bude spravován.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Vyšetřovatelé

  • Ředitel studie: GSK Clinical Trials, GlaxoSmithKline

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. listopadu 2023

Primární dokončení (Aktuální)

23. července 2025

Dokončení studie (Aktuální)

23. července 2025

Termíny zápisu do studia

První předloženo

11. srpna 2023

První předloženo, které splnilo kritéria kontroly kvality

11. srpna 2023

První zveřejněno (Aktuální)

21. srpna 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 219538
  • 2023-505414-15-00 (Identifikátor registru: CTIS)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Kvalifikovaní výzkumní pracovníci mohou požádat o přístup k anonymizovaným údajům na úrovni jednotlivých pacientů (IPD) a souvisejícím studijním dokumentům vhodných studií prostřednictvím portálu pro sdílení dat. Podrobnosti o kritériích sdílení dat GSK naleznete na: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Časový rámec sdílení IPD

Anonymizovaná IPD bude zpřístupněna do 6 měsíců od zveřejnění primárních, klíčových sekundárních a bezpečnostních výsledků pro studie s produktem se schválenou indikací (indikacemi) nebo ukončeným aktivem (aplikacemi) ve všech indikacích.

Kritéria přístupu pro sdílení IPD

Anonymizované IPD je sdíleno s výzkumníky, jejichž návrhy jsou schváleny nezávislým kontrolním panelem a poté, co je uzavřena dohoda o sdílení dat. Přístup je poskytován na počáteční období 12 měsíců, ale v odůvodněných případech může být povoleno prodloužení až na 6 měsíců.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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