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Annoksenhakututkimus GSK1070806:n turvallisuuden ja tehokkuuden tutkimiseksi aikuisilla potilailla, joilla on kohtalainen tai vaikea atooppinen ihottuma (AtDventure)

torstai 7. toukokuuta 2026 päivittänyt: GlaxoSmithKline

Vaihe 2b, satunnaistettu, kaksoissokkoutettu, rinnakkaisryhmä, lumekontrolloitu, annoksenmääritystutkimus GSK1070806 SC-injektion tehon, turvallisuuden, farmakokinetiikka ja farmakodynamiikan arvioimiseksi aikuisilla potilailla, joilla on kohtalainen tai vaikea atooppinen ihottuma

Tämä tutkimus on rinnakkaisryhmätutkimus, lumekontrolloitu annosvaihtelututkimus, jossa arvioidaan GSK1070806:n tehoa, turvallisuutta, farmakokinetiikkaa ja farmakodynamiikkaa aikuisilla potilailla, joilla on keskivaikea tai vaikea atooppinen dermatiitti (AtD) ja joita on aiemmin hoidettu paikallisilla lääkehoidoilla tai biologinen terapia.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

161

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Aikuiset osallistujat 18-75-vuotiaat

  • Osallistujat:

    • AtD määritelty AAD Consensus Criteria.
    • Diagnoosi AtD ≥1 vuosi.
    • IGA-pisteet ≥3.
    • AtD osallistuminen ≥ 10 % kehon pinta-alasta (BSA).
    • EASI-pisteet ≥16
    • Perustason kutinan numeerinen arviointiasteikon keskimääräinen pistemäärä maksimiintensiteetille vähintään 3.

  • Osallistujat ovat saaneet altistua yhdelle biologiselle terapialle, joka täyttää vähintään yhden seuraavista ehdoista:

    • Osallistujat, jotka lopettivat hoidon vasteen, osittaisen vasteen tai tehon menetyksen vuoksi.
    • Osallistujat, jotka lopettivat hoidon intoleranssin tai haittavaikutusten vuoksi.
    • Osallistujat, jotka lopettivat hoidon kustannusten tai pääsyn menettämisen vuoksi.
  • Osallistuja, jolla on äskettäin alle tai yhtä suuri (≤6) kuukautta ennen seulontakäyntiä) riittämätön vaste vakaalle paikalliselle reseptilääkitysohjelmalle.
  • Osallistujat, jotka eivät siedä reseptilääkkeitä.
  • Naisten ehkäisyn käytön tulee olla kliiniseen tutkimukseen osallistuvien ehkäisymenetelmiä koskevien paikallisten määräysten mukaista

Poissulkemiskriteerit:

  • Krooninen tai akuutti infektio, joka vaatii hoitoa oraalisilla tai suonensisäisillä antibiooteilla, viruslääkkeillä, alkueläinlääkkeillä tai sienilääkkeillä 4 viikon sisällä ennen seulontakäyntiä tai milloin tahansa seulonta- ja lähtötilanteen välisenä aikana.
  • Pinnalliset ihotulehdukset 1 viikon sisällä ennen seulontakäyntiä tai aktiiviset infektiot (mukaan lukien paikalliset infektiot) tai toistuvat infektiot (pois lukien toistuvat kynsipohjan sieni-infektiot)
  • Tunnettu, olemassa oleva tai epäilty loisinfektio 6 kuukauden sisällä ennen seulontakäyntiä.
  • Oireinen herpes zoster 3 kuukauden sisällä ennen seulontaa
  • Hallitsematon verenpainetauti.
  • Nykyinen tai krooninen maksasairaus tai tiedossa olevat maksan tai sapen poikkeavuudet.
  • Tunnettu tai epäilty immunosuppressio, mukaan lukien aiemmat invasiiviset opportunistiset infektiot infektion paranemisesta huolimatta tai epätavallisen usein toistuvista tai pitkittyneistä infektioista tutkijan arvion mukaan.
  • Lymfooma, leukemia tai mikä tahansa pahanlaatuinen kasvain viimeisen 5 vuoden aikana, paitsi ihon tyvisolu- tai levyepiteelisyövät, jotka on leikattu ilman merkkejä etäpesäkkeistä 3 vuoteen
  • Rintasyöpä viimeisen 10 vuoden aikana.
  • Merkittävän lääketieteellisen sairauden historia tai esiintyminen, mukaan lukien, mutta ei rajoittuen, sydän- ja verisuoni-, hengitystie-, maksa-, munuais-, maha-suolikanavan, endokriiniset, hematologiset, neurologiset tai psykiatriset häiriöt, jotka tutkijan mielestä häiritsevät tutkimusmenettelyjä ja/tai arviointeja.
  • Aiemmin käsitelty millä tahansa suun kautta otetulla Janus-kinaasi-inhibiittorilla (JAKi) tai muilla kokeellisilla tai hyväksytyillä kinaasiestäjillä.
  • Hallitsematon krooninen sairaus, joka saattaa vaatia suun kautta otettavia kortikosteroideja, esim. samanaikainen vakava hallitsematon astma.
  • Hepatiitti B -pinnan vasta-aineen (HBsAg) tai hepatiitti B -ydinvasta-aineen (HBcAb) läsnäolo seulonnassa tai 3 kuukauden sisällä ennen ensimmäistä tutkimusannosta.
  • Positiivinen hepatiitti C -vasta-ainetestitulos seulonnassa tai 3 kuukauden sisällä ennen tutkimustoimenpiteen aloittamista.
  • Positiivinen C-hepatiitti-RNA-testitulos seulonnassa tai 3 kuukauden sisällä ennen ensimmäistä tutkimusannosta.
  • Positiivinen HIV-vasta-ainetesti.
  • Todisteet aktiivisesta tai piilevästä tuberkuloosista, joka on dokumentoitu sairaushistorian, tutkimuksen ja tuberkuloosin testin avulla positiivisella QuantiFERON-testillä ensimmäisellä seulontakäynnillä.
  • Raskaana olevat tai imettävät naiset tai naiset, jotka suunnittelevat raskautta tai imettävät tutkimuksen aikana.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
Lääke: Plasebo
Plaseboa annetaan.
Kokeellinen: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
Lääke: GSK1070806
GSK1070806 annetaan.
Kokeellinen: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
Lääke: GSK1070806
GSK1070806 annetaan.
Kokeellinen: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
Lääke: GSK1070806
GSK1070806 annetaan.
Kokeellinen: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
Lääke: GSK1070806
GSK1070806 annetaan.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

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Sponsori

GlaxoSmithKline

Tutkijat

  • Opintojohtaja: GSK Clinical Trials, GlaxoSmithKline

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 16. marraskuuta 2023

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 23. heinäkuuta 2025

Opintojen valmistuminen (Todellinen)

Keskiviikko 23. heinäkuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 11. elokuuta 2023

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 11. elokuuta 2023

Ensimmäinen Lähetetty (Todellinen)

Maanantai 21. elokuuta 2023

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 3. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 7. toukokuuta 2026

Viimeksi vahvistettu

Perjantai 1. toukokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 219538
  • 2023-505414-15-00 (Rekisterin tunniste: CTIS)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Pätevät tutkijat voivat pyytää pääsyä anonymisoituihin yksittäisten potilastason tietoihin (IPD) ja niihin liittyviin tukikelpoisten tutkimusten tutkimusasiakirjoihin tiedonjakoportaalin kautta. Lisätietoja GSK:n tiedonjakokriteereistä on osoitteessa: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD-jaon aikakehys

Anonymisoitu IPD tulee saataville kuuden kuukauden kuluessa primaaristen, keskeisten toissijaisten ja turvallisuustulosten julkaisemisesta tutkimuksissa, jotka koskevat hyväksyttyjä käyttöaiheita tai lopetettuja hyödykkeitä kaikissa käyttöaiheissa.

IPD-jaon käyttöoikeuskriteerit

Anonymisoitu IPD jaetaan tutkijoille, joiden ehdotukset hyväksytään riippumattomassa arviointipaneelissa ja sen jälkeen, kun tiedonjakosopimus on tehty. Käyttöoikeus tarjotaan aluksi 12 kuukauden ajaksi, mutta sitä voidaan perustellusti pidentää enintään kuudeksi kuukaudeksi.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ICF
  • CSR

Lääke- ja laitetiedot, tutkimusasiakirjat

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Yhdysvalloissa valmistettu ja sieltä viety tuote

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