A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
NIMBLE
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
1 other identifier
interventional
1,717
20 countries
381
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Jan 2021
Longer than P75 for phase_3 asthma
381 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2025
CompletedResults Posted
Study results publicly available
May 18, 2026
CompletedMay 18, 2026
April 1, 2026
4.6 years
January 18, 2021
March 13, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks
Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \[such as intramuscular (IM), intravenous (IV) or oral\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.
Up to Week 52
Secondary Outcomes (3)
Weighted Mean (WM) Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
From Baseline (Day 1) up to Week 52
Weighted Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
From Baseline (Day 1) up to Week 52
Weighted Mean Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
From Baseline (Day 1) up to Week 52
Study Arms (2)
Depemokimab 100mg SC
EXPERIMENTALParticipants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
Mepolizumab 100 mg / Benralizumab 30 mg SC
ACTIVE COMPARATORParticipants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
Interventions
GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.
Mepolizumab 100 mg SC will be administered in a single-use PFS.
Benralizumab 30 mg will be administered in a single-use PFS.
Placebo will be a sterile liquid formulation.
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).
PFS will include glass barrel with pre-staked needle and plunger.
Eligibility Criteria
You may qualify if:
- 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.
- Current treatment with at least one additional controller medication, besides ICS \[for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline\].
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- IQVIA Pty Ltdcollaborator
Study Sites (397)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Scottsboro, Alabama, 35768, United States
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Litchfield Park, Arizona, 85340, United States
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Phoenix, Arizona, 85054, United States
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Scottsdale, Arizona, 85251, United States
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Bakersfield, California, 93301, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Oxnard, California, 93036, United States
GSK Investigational Site
Rancho Cucamonga, California, 91730, United States
GSK Investigational Site
Redondo Beach, California, 90277, United States
GSK Investigational Site
Redwood City, California, 94063, United States
GSK Investigational Site
Riverside, California, 91786, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Diego, California, 92307, United States
GSK Investigational Site
Valencia, California, 91324, United States
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Woodland, California, 95695, United States
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Aurora, Colorado, 80238, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80923, United States
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Denver, Colorado, 80209, United States
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Wheat Ridge, Colorado, 80033, United States
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New Haven, Connecticut, 06511, United States
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Aventura, Florida, 33180, United States
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Clearwater, Florida, 33765-2103, United States
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Fort Lauderdale, Florida, 33316, United States
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Gainesville, Florida, 32610, United States
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Hialeah, Florida, 33014, United States
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Hialeah, Florida, 33016, United States
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Jacksonville, Florida, 32209, United States
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Kissimmee, Florida, 34746, United States
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Loxahatchee Groves, Florida, 33470, United States
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Miami, Florida, 33125, United States
GSK Investigational Site
Miami, Florida, 33126, United States
GSK Investigational Site
Miami, Florida, 33144, United States
GSK Investigational Site
Miami, Florida, 33166, United States
GSK Investigational Site
Miami, Florida, 33172, United States
GSK Investigational Site
Miami, Florida, 33186, United States
GSK Investigational Site
Miami Lakes, Florida, 33014, United States
GSK Investigational Site
Miami Lakes, Florida, 33125, United States
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North Palm Beach, Florida, 33408, United States
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Orlando, Florida, 32803, United States
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Orlando, Florida, 32806, United States
GSK Investigational Site
Orlando, Florida, 32819, United States
GSK Investigational Site
Sebring, Florida, 33870, United States
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Tallahassee, Florida, 32308, United States
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Calhoun, Georgia, 30701, United States
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Glenview, Illinois, 60077, United States
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Evansville, Indiana, 47715, United States
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Overland Park, Kansas, 66210, United States
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Lexington, Kentucky, 40509, United States
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Owensboro, Kentucky, 42301, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21162, United States
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Baltimore, Maryland, 21224, United States
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Chevy Chase, Maryland, 20815, United States
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Boston, Massachusetts, 02115, United States
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Burlington, Massachusetts, 01805, United States
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New Bedford, Massachusetts, 02740, United States
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North Dartmouth, Massachusetts, 02747, United States
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Ann Arbor, Michigan, 48109, United States
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Flint, Michigan, 48507, United States
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Warren, Michigan, 48088, United States
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Minneapolis, Minnesota, 55454, United States
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Gulfport, Mississippi, 36608, United States
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Jackson, Mississippi, 39216, United States
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Chesterfield, Missouri, 63017, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63110, United States
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Lincoln, Nebraska, 68505, United States
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Omaha, Nebraska, 68198-5990, United States
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Brick, New Jersey, 08724, United States
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Northfield, New Jersey, 08225, United States
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Riverdale, New Jersey, 07457, United States
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Toms River, New Jersey, 08755, United States
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Brooklyn, New York, 11215, United States
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Corning, New York, 14845, United States
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Great Neck, New York, 11040, United States
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New York, New York, 60301, United States
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The Bronx, New York, 10459-2417, United States
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The Bronx, New York, 10467, United States
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Asheville, North Carolina, 28803, United States
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Huntersville, North Carolina, 28078, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27157, United States
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Cincinnati, Ohio, 45229, United States
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Cincinnati, Ohio, 45231, United States
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Corvallis, Oregon, 97330, United States
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Altoona, Pennsylvania, 15801, United States
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Altoona, Pennsylvania, 16601, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Wyomissing, Pennsylvania, 19610, United States
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Warwick, Rhode Island, 02886, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Hendersonville, Tennessee, 37075, United States
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Knoxville, Tennessee, 37909, United States
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Amarillo, Texas, 79106, United States
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Amarillo, Texas, 79124, United States
GSK Investigational Site
Dallas, Texas, 75225, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77429, United States
GSK Investigational Site
Kerrville, Texas, 78028, United States
GSK Investigational Site
San Antonio, Texas, 78207, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
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Murray, Utah, 84107, United States
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Richmond, Virginia, 23298, United States
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Williamsburg, Virginia, 23188, United States
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Bellingham, Washington, 98225, United States
GSK Investigational Site
Seattle, Washington, 98115, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
GSK Investigational Site
Macquarie University, New South Wales, 2109, Australia
GSK Investigational Site
Sydney, New South Wales, 2010, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Cairns, Queensland, 4870, Australia
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Bedford Park, South Australia, 5042, Australia
GSK Investigational Site
North Adelaide, South Australia, 5006, Australia
GSK Investigational Site
Toorak Gardens, South Australia, 5065, Australia
GSK Investigational Site
Woodville, South Australia, 5011, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Fitzroy, Victoria, 3065, Australia
GSK Investigational Site
Frankston, Victoria, 3199, Australia
GSK Investigational Site
Melbourne, Victoria, 3181, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Feldbach, 8330, Austria
GSK Investigational Site
Vienna, 1130, Austria
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Calgary, Alberta, T2N 4Z6, Canada
GSK Investigational Site
Edmonton, Alberta, T5J 3S9, Canada
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Moncton, New Brunswick, E1C 5K4, Canada
GSK Investigational Site
Ajax, Ontario, L1S 2J5, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 1E4, Canada
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Toronto, Ontario, M5G 1E2, Canada
GSK Investigational Site
Toronto, Ontario, M5T 3A9, Canada
GSK Investigational Site
Windsor, Ontario, N8X 1T3, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G5, Canada
GSK Investigational Site
Québec, Quebec, G1V 4W2, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Tampere, 33520, Finland
GSK Investigational Site
Turku, 20521, Finland
GSK Investigational Site
Amiens, 80000, France
GSK Investigational Site
Annecy, 74011, France
GSK Investigational Site
Antony, 92160, France
GSK Investigational Site
Besançon, 25030, France
GSK Investigational Site
Brest, 29609, France
GSK Investigational Site
Caen, 14033, France
GSK Investigational Site
Cannes, 06414, France
GSK Investigational Site
Cholet, 49300, France
GSK Investigational Site
Dijon, 21079, France
GSK Investigational Site
La Tronche, 38700, France
GSK Investigational Site
Le Mans, 72037, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Lyon, 69317, France
GSK Investigational Site
Marseille, 13003., France
GSK Investigational Site
Marseille, 13015, France
GSK Investigational Site
Montfermeil, 93370, France
GSK Investigational Site
Montivilliers, 76290, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Nice, 06001, France
GSK Investigational Site
Paris, 75014, France
GSK Investigational Site
Paris, 75015, France
GSK Investigational Site
Paris, 75877, France
GSK Investigational Site
Pontoise, 95303, France
GSK Investigational Site
Rouen, 76031, France
GSK Investigational Site
Saint-Herblain, 44093, France
GSK Investigational Site
Strasbourg, 67091, France
GSK Investigational Site
Suresnes, 92150, France
GSK Investigational Site
Toulouse, 31059, France
GSK Investigational Site
Tours, 37044, France
GSK Investigational Site
Aschaffenburg, 63739, Germany
GSK Investigational Site
Bendorf, 56170, Germany
GSK Investigational Site
Berlin, 10969, Germany
GSK Investigational Site
Berlin, 12159, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Bonn, 53119, Germany
GSK Investigational Site
Bonn, 53127, Germany
GSK Investigational Site
Darmstadt, 64283, Germany
GSK Investigational Site
Frankfurt, 60389, Germany
GSK Investigational Site
Frankfurt, 60596, Germany
GSK Investigational Site
Fürstenwalde, 15517, Germany
GSK Investigational Site
Geesthacht, 21502, Germany
GSK Investigational Site
Halle, 06108, Germany
GSK Investigational Site
Halle, 06120, Germany
GSK Investigational Site
Hamburg, 20354, Germany
GSK Investigational Site
Hanover, 30625, Germany
GSK Investigational Site
Landsberg, 86899, Germany
GSK Investigational Site
Leipzig, 04207, Germany
GSK Investigational Site
Leipzig, 04275, Germany
GSK Investigational Site
Leipzig, 04347, Germany
GSK Investigational Site
Lübeck, 23552, Germany
GSK Investigational Site
Lübeck, 23558, Germany
GSK Investigational Site
Magdeburg, 39120, Germany
GSK Investigational Site
Mainz, 55128, Germany
GSK Investigational Site
München, 81241, Germany
GSK Investigational Site
Neu-Isenburg, 63263, Germany
GSK Investigational Site
Rheine, 48431, Germany
GSK Investigational Site
Schleswig, 24837, Germany
GSK Investigational Site
Cork, T12 DFK4, Ireland
GSK Investigational Site
Dublin, D04 T6F4, Ireland
GSK Investigational Site
Dublin, D08 NHY1, Ireland
GSK Investigational Site
Beersheba, 8410101, Israel
GSK Investigational Site
Haifa, 34362, Israel
GSK Investigational Site
Jerusalem, 91031, Israel
GSK Investigational Site
Jerusalem, 91120, Israel
GSK Investigational Site
Kfar Saba, 44281, Israel
GSK Investigational Site
Petah Tikva, 49100, Israel
GSK Investigational Site
Ramat Gan, 52621, Israel
GSK Investigational Site
Tel Aviv, 64239, Israel
GSK Investigational Site
Zrifin, 70300, Israel
GSK Investigational Site
Bari, 70124, Italy
GSK Investigational Site
Bergamo, 24127, Italy
GSK Investigational Site
Bologna, 40138, Italy
GSK Investigational Site
Brescia, 25123, Italy
GSK Investigational Site
Catania, 95123, Italy
GSK Investigational Site
Ferrara, 44124, Italy
GSK Investigational Site
Florence, 50134, Italy
GSK Investigational Site
Genova, 16132, Italy
GSK Investigational Site
Mantua, 46100, Italy
GSK Investigational Site
Milan, 20122, Italy
GSK Investigational Site
Milan, 20123, Italy
GSK Investigational Site
Milan, 20132, Italy
GSK Investigational Site
Milan, 20162, Italy
GSK Investigational Site
Modena, 41124, Italy
GSK Investigational Site
Monserrato CA, 09042, Italy
GSK Investigational Site
Naples, 80131, Italy
GSK Investigational Site
Padova, 35128, Italy
GSK Investigational Site
Palermo, 90127, Italy
GSK Investigational Site
Pavia, 27100, Italy
GSK Investigational Site
Perugia, 06156, Italy
GSK Investigational Site
Pisa, 56100, Italy
GSK Investigational Site
Reggio Emilia, 42100, Italy
GSK Investigational Site
Roma, 168, Italy
GSK Investigational Site
Salerno, 84131, Italy
GSK Investigational Site
Sassari, 7100, Italy
GSK Investigational Site
Siena, 53100, Italy
GSK Investigational Site
Torino, 10128, Italy
GSK Investigational Site
Torrette AN, 60020, Italy
GSK Investigational Site
Treviso, 31100, Italy
GSK Investigational Site
Trieste, 34139, Italy
GSK Investigational Site
Verona, 37134, Italy
GSK Investigational Site
Shibuya-Ku, Tokyo, 150-8935, Japan
GSK Investigational Site
Aichi, 454-8509, Japan
GSK Investigational Site
Aichi, 470-1192, Japan
GSK Investigational Site
Aichi, 489-8642, Japan
GSK Investigational Site
Akita, 010-8543, Japan
GSK Investigational Site
Ehime, 790-0024, Japan
GSK Investigational Site
Fukuoka, 802-0052, Japan
GSK Investigational Site
Fukuoka, 805-8508, Japan
GSK Investigational Site
Fukuoka, 806-8501, Japan
GSK Investigational Site
Fukuoka, 811-1394, Japan
GSK Investigational Site
Fukuoka, 813-0017, Japan
GSK Investigational Site
Fukuoka, 830-0011, Japan
GSK Investigational Site
Fukushima, 960-1295, Japan
GSK Investigational Site
Gifu, 509-6134, Japan
GSK Investigational Site
Hiroshima, 734-8530, Japan
GSK Investigational Site
Hiroshima, 735-8585, Japan
GSK Investigational Site
Hiroshima, 737-0023, Japan
GSK Investigational Site
Hokkaido, 064-0804, Japan
GSK Investigational Site
Hyōgo, 650-0047, Japan
GSK Investigational Site
Hyōgo, 653-0013, Japan
GSK Investigational Site
Ibaraki, 302-0022, Japan
GSK Investigational Site
Ibaraki, 319-1113, Japan
GSK Investigational Site
Ishikawa, 920-0293, Japan
GSK Investigational Site
Kagawa, 762-8550, Japan
GSK Investigational Site
Kagoshima, 890-8520, Japan
GSK Investigational Site
Kanagawa, 231-8682, Japan
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Kanagawa, 232-0024, Japan
GSK Investigational Site
Kanagawa, 236-0004, Japan
GSK Investigational Site
Kanagawa, 236-0051, Japan
GSK Investigational Site
Kanagawa, 254-8502, Japan
GSK Investigational Site
Mie, 510-8561, Japan
GSK Investigational Site
Mie, 511-0061, Japan
GSK Investigational Site
Mie, 515-8544, Japan
GSK Investigational Site
Miyagi, 981-8563, Japan
GSK Investigational Site
Nagano, 386-8610, Japan
GSK Investigational Site
Niigata, 951-8520, Japan
GSK Investigational Site
Numakunai, 020-8505, Japan
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Okayama, 701-0304, Japan
GSK Investigational Site
Okayama, 702-8055, Japan
GSK Investigational Site
Osaka, 530-0012, Japan
GSK Investigational Site
Osaka, 543-8555, Japan
GSK Investigational Site
Osaka, 560-8552, Japan
GSK Investigational Site
Osaka, 569-1096, Japan
GSK Investigational Site
Osaka, 569-1192, Japan
GSK Investigational Site
Osaka, 569-8686, Japan
GSK Investigational Site
Osaka, 572-8551, Japan
GSK Investigational Site
Osaka, 593-8304, Japan
GSK Investigational Site
Osaka, 596-8501, Japan
GSK Investigational Site
Shimane, 693-8501, Japan
GSK Investigational Site
Shizuoka, 420-8527, Japan
GSK Investigational Site
Shizuoka, 430-8525, Japan
GSK Investigational Site
Tokyo, 103-0027, Japan
GSK Investigational Site
Tokyo, 105-8471, Japan
GSK Investigational Site
Tokyo, 113-8431, Japan
GSK Investigational Site
Tokyo, 113-8519, Japan
GSK Investigational Site
Tokyo, 136-0075, Japan
GSK Investigational Site
Tokyo, 141-8625, Japan
GSK Investigational Site
Tokyo, 142-8666, Japan
GSK Investigational Site
Tokyo, 160-8582, Japan
GSK Investigational Site
Tokyo, 162-8655, Japan
GSK Investigational Site
Tokyo, 173-8606, Japan
GSK Investigational Site
Tokyo, 187-8510, Japan
GSK Investigational Site
Tokyo, 190-0014, Japan
GSK Investigational Site
Tokyo, 204-8585, Japan
GSK Investigational Site
Toyama, 930-8550, Japan
GSK Investigational Site
Wakayama, 640-8558, Japan
GSK Investigational Site
Arnhem, 6815 AD, Netherlands
GSK Investigational Site
Breda, 4818 CK, Netherlands
GSK Investigational Site
Deventer, 7416 SE, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Enschede, 7513 ER, Netherlands
GSK Investigational Site
Harderwijk, 3844 DG, Netherlands
GSK Investigational Site
Leeuwarden, 8934 AD, Netherlands
GSK Investigational Site
Nijmegen, 6532 SZ, Netherlands
GSK Investigational Site
Rotterdam, 3045 PM, Netherlands
GSK Investigational Site
Zwolle, 8025 AB, Netherlands
GSK Investigational Site
Bergen, 5021, Norway
GSK Investigational Site
Lrenskog, 1478, Norway
GSK Investigational Site
Coimbra, 3041-801, Portugal
GSK Investigational Site
Guarda, 6300-035, Portugal
GSK Investigational Site
Lisbon, 1649-035, Portugal
GSK Investigational Site
Matosinhos Municipality, 4464-509, Portugal
GSK Investigational Site
Guaynabo, 00968, Puerto Rico
GSK Investigational Site
Golnik, 4204, Slovenia
GSK Investigational Site
Alcorcón, 28922, Spain
GSK Investigational Site
Almería, 04009, Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08017, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 08950, Spain
GSK Investigational Site
Barcelona, 8025, Spain
GSK Investigational Site
Benalmádena, 29631, Spain
GSK Investigational Site
Bilbao, 48013, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Jerez de la Frontera, 11407, Spain
GSK Investigational Site
La Laguna Santa Cruz, 38320, Spain
GSK Investigational Site
Madrid, 28031, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
MErida Badajoz, 06800, Spain
GSK Investigational Site
Pamplona, 31008, Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223, Spain
GSK Investigational Site
Salamanca, 37007, Spain
GSK Investigational Site
Santander, 39008, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Valencia, 46015, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Via-Real CastellOn, 12540, Spain
GSK Investigational Site
Vitoria-Gasteiz, 01009, Spain
GSK Investigational Site
Zaragoza, 50009, Spain
GSK Investigational Site
Linköping, SE-58758, Sweden
GSK Investigational Site
Lund, SE-221 85, Sweden
GSK Investigational Site
Östersund, SE-831 83, Sweden
GSK Investigational Site
Stockholm, SE-141 86, Sweden
GSK Investigational Site
Uppsala, SE-751 85, Sweden
GSK Investigational Site
Aarau, 5001, Switzerland
GSK Investigational Site
Basel, 4031, Switzerland
GSK Investigational Site
Liestal, 4410, Switzerland
GSK Investigational Site
Sankt Gallen, 9007, Switzerland
GSK Investigational Site
Banchiau Taipei, 220, Taiwan
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Changhua, 500, Taiwan
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Linkou - Taoyuan Hsien, 333, Taiwan
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Taichung, 404, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
GSK Investigational Site
Belfast, BT9 7AB, United Kingdom
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Birmingham, B9 5SS, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
GSK Investigational Site
Bristol Avon, BS10 5NB, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
GSK Investigational Site
Exeter, EX2 5DW, United Kingdom
GSK Investigational Site
Glasgow, G31 2ER, United Kingdom
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Glasgow, G51 4TF, United Kingdom
GSK Investigational Site
Liverpool, L7 8XP, United Kingdom
GSK Investigational Site
London, EC1A 7BE, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
GSK Investigational Site
Nottingham, NG5 1PB, United Kingdom
GSK Investigational Site
Oxford, OX3 9DU, United Kingdom
GSK Investigational Site
Portsmouth, PO6 3LY, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
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Wishaw, ML6 0JS, United Kingdom
Related Publications (2)
Chupp G, Nagase H, Skowasch D, Devouassoux G, Cote A, Jackson DJ, Jackson DJ, Wechsler ME, Imber V, McGinniss JE, K SO, Howarth P, Pavord ID; NIMBLE Study Investigators. Switching to twice-yearly depemokimab from mepolizumab/benralizumab in severe asthma: A multicenter, randomized, double-blind, Phase 3A Clinical Trial (NIMBLE). Am J Respir Crit Care Med. 2026 Feb 11:aamag031. doi: 10.1093/ajrccm/aamag031. Online ahead of print.
PMID: 41738176BACKGROUNDSeluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.
PMID: 39393433DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This is a double-blind study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2021
First Posted
January 22, 2021
Study Start
January 26, 2021
Primary Completion
September 14, 2025
Study Completion
September 14, 2025
Last Updated
May 18, 2026
Results First Posted
May 18, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.