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COMPLETED

NCT04718389

PHASE3

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

Official title: A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1717

Start Date

2021-01-26

Completion Date

2025-09-14

Last Updated

2026-05-18

Healthy Volunteers

Conditions

Asthma

Interventions

BIOLOGICAL

GSK3511294 (Depemokimab)

GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.

BIOLOGICAL

Mepolizumab

Mepolizumab 100 mg SC will be administered in a single-use PFS.

BIOLOGICAL

Benralizumab

Benralizumab 30 mg will be administered in a single-use PFS.

BIOLOGICAL

Placebo

Placebo will be a sterile liquid formulation.

DRUG

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).

DEVICE

Pre-filled Syringes (PFS)

PFS will include glass barrel with pre-staked needle and plunger.

Key inclusion criteria for study: * Adult and adolescent participants more than or equal to (\>=)12 years of age, at the time of signing the informed consent/assent. * 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 \[for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline\]. Key exclusion criteria for study: * Participants with presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. * 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. Key exclusion criteria for randomization: * 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.

Locations (397)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

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

GSK Investigational Site

Redondo Beach, California, United States

GSK Investigational Site

Redwood City, California, United States

GSK Investigational Site

Riverside, California, United States

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San Diego, California, United States

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San Diego, California, United States

GSK Investigational Site

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

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

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Miami, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

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Miami Lakes, Florida, United States

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North Palm Beach, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

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 University, New South Wales, Australia

GSK Investigational Site

Sydney, New South Wales, Australia

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Westmead, New South Wales, Australia

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Cairns, Queensland, Australia

GSK Investigational Site

South Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

GSK Investigational Site

Bedford Park, South Australia, Australia

GSK Investigational Site

North Adelaide, South Australia, Australia

GSK Investigational Site

Toorak Gardens, South Australia, Australia

GSK Investigational Site

Woodville, South Australia, Australia

GSK Investigational Site

Box Hill, Victoria, Australia

GSK Investigational Site

Clayton, Victoria, Australia

GSK Investigational Site

Fitzroy, Victoria, Australia

GSK Investigational Site

Frankston, Victoria, Australia

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Melbourne, Victoria, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Feldbach, Austria

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Vienna, Austria

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

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

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Trois-Rivières, Quebec, Canada

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

Florence, Italy

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Genova, Italy

GSK Investigational Site

Mantua, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

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

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Padova, Italy

GSK Investigational Site

Palermo, Italy

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Pavia, Italy

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Perugia, Italy

GSK Investigational Site

Pisa, Italy

GSK Investigational Site

Reggio Emilia, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Salerno, Italy

GSK Investigational Site

Sassari, Italy

GSK Investigational Site

Siena, Italy

GSK Investigational Site

Torino, Italy

GSK Investigational Site

Torrette AN, Italy

GSK Investigational Site

Treviso, Italy

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Trieste, Italy

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Verona, Italy

GSK Investigational Site

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

GSK Investigational Site

Ehime, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukushima, Japan

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hyōgo, Japan

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Hyōgo, Japan

GSK Investigational Site

Ibaraki, Japan

GSK Investigational Site

Ibaraki, Japan

GSK Investigational Site

Ishikawa, Japan

GSK Investigational Site

Kagawa, Japan

GSK Investigational Site

Kagoshima, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Mie, Japan

GSK Investigational Site

Mie, Japan

GSK Investigational Site

Mie, Japan

GSK Investigational Site

Miyagi, Japan

GSK Investigational Site

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

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Linkou - Taoyuan Hsien, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Belfast, United Kingdom

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Birmingham, United Kingdom

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Bradford, United Kingdom

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Bristol Avon, United Kingdom

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Cottingham, United Kingdom

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Exeter, United Kingdom

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Glasgow, United Kingdom

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Glasgow, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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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

Clinical Research Directory

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (397)