A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

Who is this study for? Child to adult patients with Asthma
What treatments are being studied? Depemokimab
Status: Completed
Location: See all (126) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Adults and adolescents greater than or equal to (\>=)12 years of age, at the time of signing the informed consent/assent.

• Participants must have a documented physician diagnosis of asthma for \>=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines and

‣ Eosinophilic phenotype: participants who have, or with high likelihood of having, asthma with an eosinophilic phenotype as per randomization criteria, and

⁃ Exacerbation history: participants who have previously confirmed history of \>=2 exacerbations requiring treatment with systemic corticosteroid (CS) (Intramuscular \[IM\], Intravenous \[IV\], or oral), in the 12 months prior to Visit 1, despite the use of medium to high-dose ICS. For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.

• Persistent airflow obstruction as indicated by (i) For participants \>=18 years of age at Visit 1, a pre-bronchodilator FEV1 less than (\<)80 percent (%) predicted National Health and Nutrition Examination Survey (NHANES III) recorded at Visit 1.

∙ (ii) For participants 12-17 years of age at Visit 1: A pre-bronchodilator FEV1 \<90% predicted (NHANES III) recorded at Visit 1 or FEV1: Forced Vital Capacity (FVC) ratio \<0.8 recorded at Visit 1.

• A well-documented requirement for regular treatment with medium to high dose ICS (in the 12 months prior to Visit 1 with or without maintenance OCS). The maintenance ICS dose must be \>=440 micrograms fluticasone propionate (FP) hydrofluoroalkane product (HFA) daily, or clinically comparable (GINA, 2020). Participants who are treated with medium dose ICS will also need to be treated with LABA to qualify for inclusion.

• Current treatment with at least one additional controller medication, besides ICS, for at least 3 months (for example \[e.g.\], LABA, LAMA, leukotriene receptor antagonist \[LTRA\], or theophylline).

• An elevated peripheral blood eosinophil count of \>=300 cells per microliter demonstrated in the past 12 months prior to Visit 1 that is related to asthma or an elevated peripheral blood eosinophil count of \>=150 cells per microliter at Screening Visit 1 that is related to asthma.

• Evidence of airway reversibility or responsiveness as documented by either:

• (i) Airway reversibility (FEV1\>=12% and 200 milliliter \[mL\]) demonstrated at Visit 1 or Visit 2 using the Maximum Post Bronchodilator Procedure or (ii) Airway reversibility (FEV1\>=12% and 200 mL) documented in the 24 months prior to Visit 2 (randomization visit) or (iii) Airway hyper-responsiveness (methacholine: Provocative concentration causing a 20% fall in FEV1 \[PC20\] of \<8 milligrams per milliliter (mg/mL), histamine: Provocative dose that decreases FEV1 by 20% \[PD20\] of \<7.8 micromoles, mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 24 months prior to Visit 2 (randomization visit).

Locations
United States
Alabama
GSK Investigational Site
Alabaster
GSK Investigational Site
Mobile
Arizona
GSK Investigational Site
Phoenix
California
GSK Investigational Site
Beverly Hills
GSK Investigational Site
Lancaster
Colorado
GSK Investigational Site
Colorado Springs
GSK Investigational Site
Lafayette
Florida
GSK Investigational Site
Aventura
GSK Investigational Site
Hialeah
GSK Investigational Site
Miami
GSK Investigational Site
Miami
GSK Investigational Site
Miami Lakes
GSK Investigational Site
Orlando
Georgia
GSK Investigational Site
Atlanta
Illinois
GSK Investigational Site
Evanston
Maryland
GSK Investigational Site
Columbia
Michigan
GSK Investigational Site
Dearborn
GSK Investigational Site
Ypsilanti
Missouri
GSK Investigational Site
St Louis
North Carolina
GSK Investigational Site
Huntersville
GSK Investigational Site
Winston-salem
New Jersey
GSK Investigational Site
Northfield
GSK Investigational Site
Toms River
New York
GSK Investigational Site
The Bronx
Ohio
GSK Investigational Site
Cincinnati
GSK Investigational Site
Cincinnati
Oklahoma
GSK Investigational Site
Edmond
Pennsylvania
GSK Investigational Site
Altoona
GSK Investigational Site
Dubois
GSK Investigational Site
Hershey
GSK Investigational Site
Philadelphia
South Dakota
GSK Investigational Site
Rapid City
Texas
GSK Investigational Site
Allen
GSK Investigational Site
Boerne
GSK Investigational Site
Dallas
GSK Investigational Site
Houston
GSK Investigational Site
San Antonio
GSK Investigational Site
San Antonio
GSK Investigational Site
San Antonio
Washington
GSK Investigational Site
Bellingham
Wisconsin
GSK Investigational Site
Milwaukee
Other Locations
Australia
GSK Investigational Site
Coffs Harbour
GSK Investigational Site
South Brisbane
Canada
GSK Investigational Site
Burlington
GSK Investigational Site
Kamloops
GSK Investigational Site
Québec
GSK Investigational Site
Sherwood Park
GSK Investigational Site
Windsor
France
GSK Investigational Site
Annecy
GSK Investigational Site
Caen
GSK Investigational Site
Cannes
GSK Investigational Site
Marseille
GSK Investigational Site
Paris
GSK Investigational Site
Strasbourg
Hungary
GSK Investigational Site
Godoll?
GSK Investigational Site
Mosonmagyaróvár
GSK Investigational Site
Szigetvár
Italy
GSK Investigational Site
Brescia
GSK Investigational Site
Foggia
GSK Investigational Site
Messina
GSK Investigational Site
Monserrato Ca
GSK Investigational Site
Palermo
GSK Investigational Site
Pietra Ligure Sv
GSK Investigational Site
Rozzano Mi
GSK Investigational Site
Salerno
GSK Investigational Site
Siena
GSK Investigational Site
Tradate Va
Japan
GSK Investigational Site
Aichi
GSK Investigational Site
Aichi
GSK Investigational Site
Chiba
GSK Investigational Site
Ehime
GSK Investigational Site
Fukui
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukushima
GSK Investigational Site
Hiroshima
GSK Investigational Site
Hokkaido
GSK Investigational Site
Hokkaido
GSK Investigational Site
Hyōgo
GSK Investigational Site
Hyōgo
GSK Investigational Site
Kagawa
GSK Investigational Site
Kagawa
GSK Investigational Site
Kagoshima
GSK Investigational Site
Kanagawa
GSK Investigational Site
Kanagawa
GSK Investigational Site
Niigata
GSK Investigational Site
Okayama
GSK Investigational Site
Saga
GSK Investigational Site
Shizuoka
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
Poland
GSK Investigational Site
Gdansk
GSK Investigational Site
Krakow
GSK Investigational Site
Krakow
GSK Investigational Site
Ostrowiec Świętokrzyski
GSK Investigational Site
Rzeszów
GSK Investigational Site
Strzelce Opolskie
GSK Investigational Site
Wroclaw
Spain
GSK Investigational Site
Almería
GSK Investigational Site
Badalona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Bilbao
GSK Investigational Site
Girona
GSK Investigational Site
Jerez De La Frontera
GSK Investigational Site
La Laguna Santa Cruz
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Málaga
GSK Investigational Site
Pozuelo De Alarcon Madr
GSK Investigational Site
Santander
GSK Investigational Site
Santiago De Compostela
GSK Investigational Site
Valencia
GSK Investigational Site
Zaragoza
Taiwan
GSK Investigational Site
Kaohsiung City
GSK Investigational Site
Linkou - Taoyuan Hsien
GSK Investigational Site
Taichung
GSK Investigational Site
Taichung
GSK Investigational Site
Tainan
GSK Investigational Site
Taipei
Time Frame
Start Date: 2021-02-04
Completion Date: 2024-04-11
Participants
Target number of participants: 397
Treatments
Experimental: GSK3511294
Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.
Placebo_comparator: Placebo
Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.
Related Therapeutic Areas
Sponsors
Collaborators: Iqvia Pty Ltd
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov