A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
NCT ID: NCT04718389
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1719 participants
INTERVENTIONAL
2021-01-26
2025-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment
Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor \[anti-IL-5/5R\] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS).
Placebo
Placebo will be a sterile liquid formulation.
Standard of care (SoC)
Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
Pre-filled Syringes (PFS)
PFS will include glass barrel with pre-staked needle and plunger.
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)
Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Mepolizumab
Mepolizumab will be provided in a single-use PFS.
Benralizumab
Benralizumab will be provided in a single-use PFS.
Placebo
Placebo will be a sterile liquid formulation.
Standard of care (SoC)
Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
Pre-filled Syringes (PFS)
PFS will include glass barrel with pre-staked needle and plunger.
Interventions
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GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS).
Mepolizumab
Mepolizumab will be provided in a single-use PFS.
Benralizumab
Benralizumab will be provided in a single-use PFS.
Placebo
Placebo will be a sterile liquid formulation.
Standard of care (SoC)
Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
Pre-filled Syringes (PFS)
PFS will include glass barrel with pre-staked needle and plunger.
Eligibility Criteria
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Inclusion Criteria
* Participants who 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.
* Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for \>=12 months prior to screening and have a documented benefit to therapy assessed by either:
(i) \>=50% reduction in exacerbation frequency since initiating treatment, or (ii) \>=50% reduction in maintenance OCS use since initiating treatment, or (iii) No exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (\<=)1.5 at screening.
* 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. Participants who are treated with medium dose ICS will also need to be treated with a LABA to qualify for inclusion.
* Current treatment with at least one additional controller medication, besides ICS \[for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline\].
Exclusion Criteria
* Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
* Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
* Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment.
* Participants who have received Omalizumab (Xolair), dupilumab (Dupixent) or reslizumab (Cinqair/Cinqaero) within 130 days prior to Visit 1.
* Participants who have received any Monoclonal antibody (mAb) within 5 half-lives of Visit 1.
* Corrected QT interval using Fridericia's formula (QTcF) \>=450 milliseconds (msec) or QTcF \>=480 msec for participants with Bundle Branch Block at screening Visit 1.
* Current smokers or former smokers with a smoking history of \>=10 pack years (number of pack years equal to \[number of cigarettes per day/20\] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.
* Participants with allergy/intolerance to a mAb or biologic.
* Evidence of a clinically significant abnormality in the 12-lead electrocardiogram (ECG) over-read conducted at Screening Visit 1, based on the evaluation of the investigator, or QTcF \>=450 msec or QTcF \>=480 msec for participants with Bundle Branch Block, at randomization Visit 2.
* Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable. If the 8-week screening period has elapsed, then the participant should be considered a run-in failure.
* Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period.
12 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Scottsboro, Alabama, United States
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Litchfield Park, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Bakersfield, California, United States
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Encinitas, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Oxnard, California, United States
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Rancho Cucamonga, California, United States
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Redondo Beach, California, United States
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Redwood City, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Valencia, California, United States
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Woodland, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Wheat Ridge, Colorado, United States
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New Haven, Connecticut, United States
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Aventura, Florida, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Miami Lakes, Florida, United States
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North Palm Beach, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Sebring, Florida, United States
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Tallahassee, Florida, United States
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Calhoun, Georgia, United States
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Glenview, Illinois, United States
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Evansville, Indiana, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Chevy Chase, Maryland, United States
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Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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New Bedford, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Flint, Michigan, United States
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Warren, Michigan, United States
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Minneapolis, Minnesota, United States
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Gulfport, Mississippi, United States
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Jackson, Mississippi, United States
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Chesterfield, Missouri, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Brick, New Jersey, United States
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Northfield, New Jersey, United States
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Riverdale, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Corning, New York, United States
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Great Neck, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Huntersville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Corvallis, Oregon, United States
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Altoona, Pennsylvania, United States
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Altoona, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Rock Hill, South Carolina, United States
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Spartanburg, South Carolina, United States
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Hendersonville, Tennessee, United States
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Knoxville, Tennessee, United States
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Amarillo, Texas, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Richmond, Virginia, United States
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Williamsburg, Virginia, United States
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Bellingham, Washington, United States
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Seattle, Washington, United States
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Greenfield, Wisconsin, United States
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Macquarie Park, New South Wales, Australia
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Sydney, New South Wales, Australia
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Westmead, New South Wales, Australia
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Cairns, Queensland, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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North Adelaide, South Australia, Australia
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Toorak Gardens, South Australia, Australia
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Woodville, South Australia, Australia
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Box Hill, Victoria, Australia
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Clayton, Victoria, Australia
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Fitzroy, Victoria, Australia
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Frankston, Victoria, Australia
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Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Feldbach, , Austria
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Vienna, , Austria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Moncton, New Brunswick, Canada
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Ajax, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Tampere, , Finland
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Turku, , Finland
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Amiens, , France
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Annecy, , France
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Antony, , France
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Besançon, , France
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Brest, , France
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Caen, , France
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Cannes, , France
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Cholet, , France
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Dijon, , France
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La Tronche, , France
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Le Mans, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Marseille, , France
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Montfermeil, , France
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Montivilliers, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Pontoise, , France
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Rouen, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Suresnes, , France
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Toulouse, , France
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Tours, , France
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Aschaffenburg, , Germany
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Bendorf, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Bonn, , Germany
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Darmstadt, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Fürstenwalde, , Germany
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Geesthacht, , Germany
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Halle, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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München, , Germany
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Neu-Isenburg, , Germany
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Rheine, , Germany
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Schleswig, , Germany
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Cork, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Zrifin, , Israel
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Bari, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Catania, , Italy
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Ferrara, , Italy
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Florence, , Italy
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Genova, , Italy
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Mantova, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Monserrato CA, , Italy
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Napoli, , Italy
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Padua, , Italy
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Palermo, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Salerno, , Italy
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Sassari, , Italy
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Siena, , Italy
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Torino, , Italy
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Torrette AN, , Italy
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Treviso, , Italy
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Trieste, , Italy
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Verona, , Italy
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Shibuya-Ku, Tokyo, Japan
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Aichi, , Japan
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Aichi, , Japan
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Aichi, , Japan
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Akita, , Japan
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Ehime, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Gifu, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
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Hyōgo, , Japan
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Ibaraki, , Japan
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Ibaraki, , Japan
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Ishikawa, , Japan
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Kagawa, , Japan
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Kagoshima, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Mie, , Japan
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Mie, , Japan
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Mie, , Japan
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Miyagi, , Japan
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Nagano, , Japan
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Niigata, , Japan
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Numakunai, , Japan
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Okayama, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Shimane, , Japan
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Shizuoka, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Toyama, , Japan
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Wakayama, , Japan
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Arnhem, , Netherlands
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Breda, , Netherlands
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Deventer, , Netherlands
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Eindhoven, , Netherlands
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Enschede, , Netherlands
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Harderwijk, , Netherlands
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Leeuwarden, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Zwolle, , Netherlands
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Bergen, , Norway
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Lrenskog, , Norway
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Coimbra, , Portugal
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Guarda, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Guaynabo, , Puerto Rico
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Golnik, , Slovenia
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Alcorcón, , Spain
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Almería, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Benalmádena, , Spain
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Bilbao, , Spain
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Granada, , Spain
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Jerez de la Frontera, , Spain
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La Laguna Santa Cruz, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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MErida Badajoz, , Spain
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Pamplona, , Spain
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Pozuelo de AlarcOn Madr, , Spain
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Salamanca, , Spain
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Santander, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Via-Real CastellOn, , Spain
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Vitoria-Gasteiz, , Spain
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Zaragoza, , Spain
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Linköping, , Sweden
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Lund, , Sweden
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Östersund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Aarau, , Switzerland
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Basel, , Switzerland
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Liestal, , Switzerland
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Sankt Gallen, , Switzerland
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Banchiau Taipei, , Taiwan
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Changhua, , Taiwan
GSK Investigational Site
Linkou - Taoyuan Hsien, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Belfast, , United Kingdom
GSK Investigational Site
Birmingham, , United Kingdom
GSK Investigational Site
Bradford, , United Kingdom
GSK Investigational Site
Bristol Avon, , United Kingdom
GSK Investigational Site
Cottingham, , United Kingdom
GSK Investigational Site
Exeter, , United Kingdom
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
Liverpool, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Newcastle upon Tyne, , United Kingdom
GSK Investigational Site
Nottingham, , United Kingdom
GSK Investigational Site
Oxford, , United Kingdom
GSK Investigational Site
Portsmouth, , United Kingdom
GSK Investigational Site
Preston, , United Kingdom
GSK Investigational Site
Wakefield, , United Kingdom
GSK Investigational Site
Wishaw, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
206785
Identifier Type: -
Identifier Source: org_study_id
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