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Une étude de recherche de dose pour étudier l'innocuité et l'efficacité de GSK1070806 chez des participants adultes atteints de dermatite atopique modérée à sévère (AtDventure)

7 mai 2026 mis à jour par: GlaxoSmithKline

Une étude de recherche de dose de phase 2b, randomisée, en double aveugle, en groupes parallèles, contrôlée par placebo pour évaluer l'efficacité, l'innocuité, la pharmacocinétique et la pharmacodynamique de l'injection SC de GSK1070806 chez des participants adultes atteints de dermatite atopique modérée à sévère

Cette étude est une étude de dosage en groupes parallèles, contrôlée par placebo, visant à évaluer l'efficacité, l'innocuité, la pharmacocinétique et la pharmacodynamique de GSK1070806 chez des participants adultes atteints de dermatite atopique modérée à sévère (AtD), qui ont déjà été traités avec des traitements topiques médicamenteux ou un thérapie biologique.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

161

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Participants adultes de 18 à 75 ans

  • Intervenants avec :

    • AtD défini par les critères de consensus AAD.
    • Diagnostic d'AtD ≥1 an.
    • Un score IGA ≥3.
    • Implication AtD de ≥ 10 % de la surface corporelle (BSA).
    • Score EASI ≥16
    • Score moyen de l'échelle d'évaluation numérique du prurit de base pour une intensité maximale d'au moins 3.

  • Les participants peuvent avoir été exposés à 1 traitement biologique répondant à au moins 1 des conditions suivantes :

    • Participants ayant arrêté le traitement en raison d'une non-réponse, d'une réponse partielle, d'une perte d'efficacité.
    • Participants ayant arrêté le traitement en raison d'une intolérance ou d'EI.
    • Participants qui ont arrêté le traitement en raison du coût ou de la perte d'accès.
  • Participant ayant des antécédents récents inférieurs ou égaux à (≤6) mois avant la visite de dépistage) de réponse inadéquate à un régime stable de médicaments topiques sur ordonnance.
  • Participants pour qui les médicaments topiques sur ordonnance ne sont pas tolérés.
  • L'utilisation de la contraception par les femmes doit être conforme aux réglementations locales concernant les méthodes de contraception pour celles qui participent à l'étude clinique

Critère d'exclusion:

  • Infection chronique ou aiguë nécessitant un traitement avec des antibiotiques oraux ou IV, des antiviraux, des antiprotozoaires ou des antifongiques dans les 4 semaines précédant la visite de dépistage ou à tout moment entre les visites de dépistage et de référence.
  • Infections cutanées superficielles dans la semaine précédant la visite de dépistage ou infections actives (y compris les infections localisées), ou antécédents d'infections récurrentes (à l'exclusion des infections fongiques récurrentes du lit de l'ongle)
  • Infection parasitaire connue, préexistante ou suspectée dans les 6 mois précédant la visite de dépistage.
  • Zona symptomatique dans les 3 mois précédant le dépistage
  • Hypertension non contrôlée.
  • Antécédents actuels ou chroniques de maladie du foie ou anomalies hépatiques ou biliaires connues.
  • Antécédents connus ou suspectés d'immunosuppression, y compris des antécédents d'infections opportunistes invasives malgré la résolution de l'infection ou des infections inhabituellement fréquentes, récurrentes ou prolongées, selon le jugement de l'investigateur.
  • Lymphome, leucémie ou toute tumeur maligne au cours des 5 dernières années, à l'exception des carcinomes basocellulaires ou épithéliaux squameux de la peau qui ont été réséqués sans signe de maladie métastatique depuis 3 ans
  • Cancer du sein au cours des 10 dernières années.
  • Antécédents ou présence d'une maladie médicale importante, y compris, mais sans s'y limiter, des troubles cardiovasculaires, respiratoires, hépatiques, rénaux, gastro-intestinaux, endocriniens, hématologiques, neurologiques ou psychiatriques qui, de l'avis de l'investigateur, interféreraient avec les procédures et / ou les évaluations de l'étude.
  • Précédemment traité avec un inhibiteur oral de Janus Kinase (JAKi) ou d'autres inhibiteurs de kinase, expérimentaux ou approuvés.
  • Maladie chronique non contrôlée pouvant nécessiter des poussées de corticostéroïdes oraux, par exemple, asthme sévère non contrôlé comorbide.
  • Présence d'anticorps de surface de l'hépatite B (HBsAg) ou d'anticorps de base de l'hépatite B (HBcAb) lors du dépistage ou dans les 3 mois précédant la première dose de l'intervention à l'étude.
  • Résultat positif du test d'anticorps anti-hépatite C lors du dépistage ou dans les 3 mois précédant le début de l'intervention de l'étude.
  • Résultat positif du test d'ARN de l'hépatite C lors du dépistage ou dans les 3 mois précédant la première dose de l'intervention à l'étude.
  • Test d'anticorps VIH positif.
  • Preuve de tuberculose active ou latente documentée par les antécédents médicaux, l'examen et le test de dépistage de la tuberculose avec un test QuantiFERON positif lors de la visite de dépistage initiale.
  • Femmes enceintes ou allaitantes, ou femmes prévoyant de devenir enceintes ou d'allaiter pendant l'étude.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Participants received placebo subcutaneous (SC) injections for 16 weeks.
Médicament: Placebo
Un placebo sera administré.
Expérimental: GSK1070806 Dose Level 1
Participants received GSK1070806 dose level 1 SC injection for 16 weeks. Dose level 1 is the lowest dose level.
Médicament: GSK1070806
GSK1070806 sera administré.
Expérimental: GSK1070806 Dose Level 2
Participants received GSK1070806 dose level 2 SC injection for 16 weeks. Dose level 2 is greater than dose level 1.
Médicament: GSK1070806
GSK1070806 sera administré.
Expérimental: GSK1070806 Dose Level 3
Participants received GSK1070806 dose level 3 SC injection for 16 weeks. Dose level 3 is greater than dose level 2.
Médicament: GSK1070806
GSK1070806 sera administré.
Expérimental: GSK1070806 Dose Level 4
Participants received GSK1070806 dose level 4 SC injection for 16 weeks. Dose level 4 is greater than dose level 3.
Médicament: GSK1070806
GSK1070806 sera administré.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percent Change From Baseline (CFB) in EASI Score at Each Time Point
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

Les enquêteurs

  • Directeur d'études: GSK Clinical Trials, GlaxoSmithKline

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 novembre 2023

Achèvement primaire (Réel)

23 juillet 2025

Achèvement de l'étude (Réel)

23 juillet 2025

Dates d'inscription aux études

Première soumission

11 août 2023

Première soumission répondant aux critères de contrôle qualité

11 août 2023

Première publication (Réel)

21 août 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 219538
  • 2023-505414-15-00 (Identificateur de registre: CTIS)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Les chercheurs qualifiés peuvent demander l'accès aux données anonymisées individuelles au niveau du patient (DPI) et aux documents d'étude connexes des études éligibles via le portail de partage de données. Des détails sur les critères de partage de données de GSK sont disponibles sur : https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Délai de partage IPD

Les IPD anonymisées seront mises à disposition dans les 6 mois suivant la publication des résultats primaires, secondaires clés et de sécurité pour les études sur les produits avec indication(s) approuvée(s) ou actif(s) terminé(s) dans toutes les indications.

Critères d'accès au partage IPD

Les IPD anonymisées sont partagées avec les chercheurs dont les propositions sont approuvées par un comité d'examen indépendant et après la mise en place d'un accord de partage de données. L'accès est accordé pour une période initiale de 12 mois, mais une prolongation peut être accordée, lorsqu'elle est justifiée, jusqu'à 6 mois.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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