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? Patients with severe uncontrolled asthma with an eosinophilic phenotype
What treatments are being studied? GSK3511294
Status: Completed
Location: See all (118) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) 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 (NHLBI) guidelines or Global Initiative for Asthma (GINA) guidelines and

‣ Have, or with high likelihood of having, asthma with an eosinophilic phenotype

⁃ 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:

‣ For participants \>=18 years of age at Visit 1, a pre-bronchodilator FEV1 less than (\<)80% predicted (The Third National Health and Nutrition Examination Survey \[NHANES III\]) recorded at Visit 1

⁃ 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 (mcg) Fluticasone propionate (FP) Hydrofluoroalkane (HFA) product daily, or clinically comparable (GINA). 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).

⁃ Key randomization inclusion criteria:

• For blood eosinophilic count:

‣ An elevated peripheral blood eosinophil count of \>=300 cells/microliter (mcL) 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/mcL at Screening Visit 1 that is related to asthma.

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

‣ Airway reversibility (FEV1\>=12% and 200 milliliters \[mL\]) demonstrated at Visit 1 or Visit 2 using the Maximum Post Bronchodilator Procedure OR

⁃ Airway reversibility (FEV1\>=12% and 200 mL) documented in the 24 months prior to Visit 2 (randomization visit) OR

⁃ Airway hyperresponsiveness (methacholine: Provocative concentration causing a 20% fall in FEV1 \[PC20\] of \<8 milligrams (mg)/mL, histamine: 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
California
GSK Investigational Site
Encinitas
GSK Investigational Site
Long Beach
GSK Investigational Site
Pasadena
GSK Investigational Site
Rancho Cucamonga
GSK Investigational Site
San Jose
Florida
GSK Investigational Site
Coral Gables
GSK Investigational Site
Loxahatchee Groves
GSK Investigational Site
Miami
GSK Investigational Site
Miami
GSK Investigational Site
New Port Richey
GSK Investigational Site
Orlando
Georgia
GSK Investigational Site
Alpharetta
GSK Investigational Site
Calhoun
GSK Investigational Site
Columbus
GSK Investigational Site
Savannah
Illinois
GSK Investigational Site
Normal
Kentucky
GSK Investigational Site
Lexington
GSK Investigational Site
Owensboro
Michigan
GSK Investigational Site
Rochester Hills
North Carolina
GSK Investigational Site
Gastonia
Nevada
GSK Investigational Site
Las Vegas
New York
GSK Investigational Site
Bronx
GSK Investigational Site
New York
Ohio
GSK Investigational Site
Cleveland
Texas
GSK Investigational Site
Boerne
GSK Investigational Site
Cypress
GSK Investigational Site
Cypress
GSK Investigational Site
Dallas
GSK Investigational Site
Kerrville
GSK Investigational Site
San Antonio
Other Locations
Canada
GSK Investigational Site
Ajax
GSK Investigational Site
Niagara Falls
GSK Investigational Site
Ottawa
GSK Investigational Site
Quebec
GSK Investigational Site
Windsor
China
GSK Investigational Site
Changchun
GSK Investigational Site
Changchun
GSK Investigational Site
Changsha
GSK Investigational Site
Chengdu
GSK Investigational Site
Guangzhou
GSK Investigational Site
Guangzhou
GSK Investigational Site
Guangzhou
GSK Investigational Site
Guangzhou
GSK Investigational Site
Hangzhou
GSK Investigational Site
Hefei
GSK Investigational Site
Hohhot
GSK Investigational Site
Huhhot
GSK Investigational Site
Jinan
GSK Investigational Site
Sanya
GSK Investigational Site
Shanghai
GSK Investigational Site
Shanghai
GSK Investigational Site
Shanghai
GSK Investigational Site
Shenyang
GSK Investigational Site
Shenyang
GSK Investigational Site
Shenzhen
GSK Investigational Site
Urumqi
GSK Investigational Site
Wenzhou
GSK Investigational Site
Wuhan
GSK Investigational Site
Xi'an
GSK Investigational Site
Xuzhou
GSK Investigational Site
Zhanjiang
France
GSK Investigational Site
Besancon
GSK Investigational Site
Cholet
GSK Investigational Site
Marseille
GSK Investigational Site
Montpellier Cedex
GSK Investigational Site
Nice
GSK Investigational Site
Tarbes Cedex 9
Germany
GSK Investigational Site
Aschaffenburg
GSK Investigational Site
Berlin
GSK Investigational Site
Frankfurt
GSK Investigational Site
Hamburg
GSK Investigational Site
Koblenz
GSK Investigational Site
Leipzig
GSK Investigational Site
Leipzig
GSK Investigational Site
Magdeburg
GSK Investigational Site
Mainz
GSK Investigational Site
Neu-isenburg
GSK Investigational Site
Schleswig
Ireland
GSK Investigational Site
Cork
GSK Investigational Site
Dublin 9
Italy
GSK Investigational Site
Bergamo
GSK Investigational Site
Milano
GSK Investigational Site
Modena
GSK Investigational Site
Pavia
GSK Investigational Site
Roma
GSK Investigational Site
Vicenza
Poland
GSK Investigational Site
Kielce
GSK Investigational Site
Krakow
GSK Investigational Site
Lodz
GSK Investigational Site
Lublin
GSK Investigational Site
Strzelce Opolskie
GSK Investigational Site
Tarnow
GSK Investigational Site
Wroclaw
GSK Investigational Site
Wroclaw
Russian Federation
GSK Investigational Site
Kemerovo
GSK Investigational Site
Moscow
GSK Investigational Site
Moscow
GSK Investigational Site
Novosibirsk
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Saint-petersburg
GSK Investigational Site
St Petersburg
GSK Investigational Site
Yaroslavl
Spain
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Benalmadena
GSK Investigational Site
Gerona
GSK Investigational Site
Granada
GSK Investigational Site
Madrid
GSK Investigational Site
Palma De Mallorca
GSK Investigational Site
Santa Cruz De Tenerife
GSK Investigational Site
Valencia
GSK Investigational Site
Valencia
United Kingdom
GSK Investigational Site
Birmingham
GSK Investigational Site
Bradford
GSK Investigational Site
Chertsey
GSK Investigational Site
London
GSK Investigational Site
Manchester
GSK Investigational Site
Nottingham
Time Frame
Start Date: 2021-03-17
Completion Date: 2023-11-21
Participants
Target number of participants: 395
Treatments
Experimental: GSK3511294
Participants received a 100 milligram (mg) dose of GSK3511294 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.
Placebo_comparator: Placebo
Participants received placebo 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.
Related Therapeutic Areas
Sponsors
Collaborators: Iqvia Pty Ltd
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov