AzTrials
AzTrials

AsthmaPhase 3NIMBLENCT04718389

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

A Phase 3 study testing GSK3511294 (Depemokimab), Mepolizumab and Benralizumab in people with Asthma, run by GlaxoSmithKline at 397 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
GSK3511294 (Depemokimab), Mepolizumab and Benralizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,717 participants
Where
397 sitesin 21 countries
Study dates
26 Jan 2021to 14 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
  • >=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].

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

397 sites in 21 countries.

397 sites in 21 countries

United States119 sites

  • GSK Investigational Site

    Altoona, Pennsylvania, 15801

  • GSK Investigational Site

    Altoona, Pennsylvania, 16601

  • GSK Investigational Site

    Amarillo, Texas, 79106

  • GSK Investigational Site

    Amarillo, Texas, 79124

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Asheville, North Carolina, 28803

  • GSK Investigational Site

    Aurora, Colorado, 80238

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Baltimore, Maryland, 21162

  • GSK Investigational Site

    Baltimore, Maryland, 21224

  • GSK Investigational Site

    Bangor, Maine, 04401

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Birmingham, Alabama, 35209

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Brick, New Jersey, 08724

  • GSK Investigational Site

    Brooklyn, New York, 11215

  • GSK Investigational Site

    Burlington, Massachusetts, 01805

  • GSK Investigational Site

    Calhoun, Georgia, 30701

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Chevy Chase, Maryland, 20815

  • GSK Investigational Site

    Cincinnati, Ohio, 45229

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Clearwater, Florida, 33765-2103

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Colorado Springs, Colorado, 80923

  • GSK Investigational Site

    Corning, New York, 14845

  • GSK Investigational Site

    Corvallis, Oregon, 97330

  • GSK Investigational Site

    Dallas, Texas, 75225

  • GSK Investigational Site

    Dallas, Texas, 75235

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Denver, Colorado, 80209

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Evansville, Indiana, 47715

  • GSK Investigational Site

    Flint, Michigan, 48507

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Gainesville, Florida, 32610

  • GSK Investigational Site

    Glenview, Illinois, 60077

  • GSK Investigational Site

    Great Neck, New York, 11040

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Gulfport, Mississippi, 36608

  • GSK Investigational Site

    Hendersonville, Tennessee, 37075

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hialeah, Florida, 33014

  • GSK Investigational Site

    Hialeah, Florida, 33016

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77429

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Jackson, Mississippi, 39216

  • GSK Investigational Site

    Jacksonville, Florida, 32209

  • GSK Investigational Site

    Kerrville, Texas, 78028

  • GSK Investigational Site

    Kissimmee, Florida, 34746

  • GSK Investigational Site

    Knoxville, Tennessee, 37909

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Lincoln, Nebraska, 68505

  • GSK Investigational Site

    Litchfield Park, Arizona, 85340

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Loxahatchee Groves, Florida, 33470

  • GSK Investigational Site

    Miami, Florida, 33125

  • GSK Investigational Site

    Miami, Florida, 33126

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33166

  • GSK Investigational Site

    Miami, Florida, 33172

  • GSK Investigational Site

    Miami, Florida, 33186

  • GSK Investigational Site

    Miami Lakes, Florida, 33014

  • GSK Investigational Site

    Miami Lakes, Florida, 33125

  • GSK Investigational Site

    Minneapolis, Minnesota, 55454

  • GSK Investigational Site

    Murray, Utah, 84107

  • GSK Investigational Site

    New Bedford, Massachusetts, 02740

  • GSK Investigational Site

    New Haven, Connecticut, 06511

  • GSK Investigational Site

    New York, New York, 60301

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    North Palm Beach, Florida, 33408

  • GSK Investigational Site

    Northfield, New Jersey, 08225

  • GSK Investigational Site

    Omaha, Nebraska, 68198-5990

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Orlando, Florida, 32819

  • GSK Investigational Site

    Overland Park, Kansas, 66210

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Oxnard, California, 93036

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Phoenix, Arizona, 85054

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Rancho Cucamonga, California, 91730

  • GSK Investigational Site

    Redondo Beach, California, 90277

  • GSK Investigational Site

    Redwood City, California, 94063

  • GSK Investigational Site

    Richmond, Virginia, 23298

  • GSK Investigational Site

    Riverdale, New Jersey, 07457

  • GSK Investigational Site

    Riverside, California, 91786

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    San Antonio, Texas, 78207

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    San Diego, California, 92307

  • GSK Investigational Site

    Scottsboro, Alabama, 35768

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Seattle, Washington, 98115

  • GSK Investigational Site

    Sebring, Florida, 33870

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    The Bronx, New York, 10459-2417

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Toms River, New Jersey, 08755

  • GSK Investigational Site

    Valencia, California, 91324

  • GSK Investigational Site

    Warren, Michigan, 48088

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Williamsburg, Virginia, 23188

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

  • GSK Investigational Site

    Woodland, California, 95695

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan66 sites

  • GSK Investigational Site

    Aichi, 454-8509

  • GSK Investigational Site

    Aichi, 470-1192

  • GSK Investigational Site

    Aichi, 489-8642

  • GSK Investigational Site

    Akita, 010-8543

  • GSK Investigational Site

    Ehime, 790-0024

  • GSK Investigational Site

    Fukuoka, 802-0052

  • GSK Investigational Site

    Fukuoka, 805-8508

  • GSK Investigational Site

    Fukuoka, 806-8501

  • GSK Investigational Site

    Fukuoka, 811-1394

  • GSK Investigational Site

    Fukuoka, 813-0017

  • GSK Investigational Site

    Fukuoka, 830-0011

  • GSK Investigational Site

    Fukushima, 960-1295

  • GSK Investigational Site

    Gifu, 509-6134

  • GSK Investigational Site

    Hiroshima, 734-8530

  • GSK Investigational Site

    Hiroshima, 735-8585

  • GSK Investigational Site

    Hiroshima, 737-0023

  • GSK Investigational Site

    Hokkaido, 064-0804

  • GSK Investigational Site

    Hyōgo, 650-0047

  • GSK Investigational Site

    Hyōgo, 653-0013

  • GSK Investigational Site

    Ibaraki, 302-0022

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Ishikawa, 920-0293

  • GSK Investigational Site

    Kagawa, 762-8550

  • GSK Investigational Site

    Kagoshima, 890-8520

  • GSK Investigational Site

    Kanagawa, 231-8682

  • GSK Investigational Site

    Kanagawa, 232-0024

  • GSK Investigational Site

    Kanagawa, 236-0004

  • GSK Investigational Site

    Kanagawa, 236-0051

  • GSK Investigational Site

    Kanagawa, 254-8502

  • GSK Investigational Site

    Mie, 510-8561

  • GSK Investigational Site

    Mie, 511-0061

  • GSK Investigational Site

    Mie, 515-8544

  • GSK Investigational Site

    Miyagi, 981-8563

  • GSK Investigational Site

    Nagano, 386-8610

  • GSK Investigational Site

    Niigata, 951-8520

  • GSK Investigational Site

    Numakunai, 020-8505

  • GSK Investigational Site

    Okayama, 701-0304

  • GSK Investigational Site

    Okayama, 702-8055

  • GSK Investigational Site

    Osaka, 530-0012

  • GSK Investigational Site

    Osaka, 543-8555

  • GSK Investigational Site

    Osaka, 560-8552

  • GSK Investigational Site

    Osaka, 569-1096

  • GSK Investigational Site

    Osaka, 569-1192

  • GSK Investigational Site

    Osaka, 569-8686

  • GSK Investigational Site

    Osaka, 572-8551

  • GSK Investigational Site

    Osaka, 593-8304

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Shibuya-Ku, Tokyo, 150-8935

  • GSK Investigational Site

    Shimane, 693-8501

  • GSK Investigational Site

    Shizuoka, 420-8527

  • GSK Investigational Site

    Shizuoka, 430-8525

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 105-8471

  • GSK Investigational Site

    Tokyo, 113-8431

  • GSK Investigational Site

    Tokyo, 113-8519

  • GSK Investigational Site

    Tokyo, 136-0075

  • GSK Investigational Site

    Tokyo, 141-8625

  • GSK Investigational Site

    Tokyo, 142-8666

  • GSK Investigational Site

    Tokyo, 160-8582

  • GSK Investigational Site

    Tokyo, 162-8655

  • GSK Investigational Site

    Tokyo, 173-8606

  • GSK Investigational Site

    Tokyo, 187-8510

  • GSK Investigational Site

    Tokyo, 190-0014

  • GSK Investigational Site

    Tokyo, 204-8585

  • GSK Investigational Site

    Toyama, 930-8550

  • GSK Investigational Site

    Wakayama, 640-8558

Other trials in Japan

Italy31 sites

  • GSK Investigational Site

    Bari, 70124

  • GSK Investigational Site

    Bergamo, 24127

  • GSK Investigational Site

    Bologna, 40138

  • GSK Investigational Site

    Brescia, 25123

  • GSK Investigational Site

    Catania, 95123

  • GSK Investigational Site

    Ferrara, 44124

  • GSK Investigational Site

    Florence, 50134

  • GSK Investigational Site

    Genova, 16132

  • GSK Investigational Site

    Mantua, 46100

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Milan, 20123

  • GSK Investigational Site

    Milan, 20132

  • GSK Investigational Site

    Milan, 20162

  • GSK Investigational Site

    Modena, 41124

  • GSK Investigational Site

    Monserrato CA, 09042

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Padova, 35128

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Pavia, 27100

  • GSK Investigational Site

    Perugia, 06156

  • GSK Investigational Site

    Pisa, 56100

  • GSK Investigational Site

    Reggio Emilia, 42100

  • GSK Investigational Site

    Roma, 168

  • GSK Investigational Site

    Salerno, 84131

  • GSK Investigational Site

    Sassari, 7100

  • GSK Investigational Site

    Siena, 53100

  • GSK Investigational Site

    Torino, 10128

  • GSK Investigational Site

    Torrette AN, 60020

  • GSK Investigational Site

    Treviso, 31100

  • GSK Investigational Site

    Trieste, 34139

  • GSK Investigational Site

    Verona, 37134

Other trials in Italy

Spain30 sites

  • GSK Investigational Site

    Alcorcón, 28922

  • GSK Investigational Site

    Almería, 04009

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08017

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08950

  • GSK Investigational Site

    Barcelona, 8025

  • GSK Investigational Site

    Benalmádena, 29631

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Jerez de la Frontera, 11407

  • GSK Investigational Site

    La Laguna Santa Cruz, 38320

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    MErida Badajoz, 06800

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223

  • GSK Investigational Site

    Salamanca, 37007

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46015

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Via-Real CastellOn, 12540

  • GSK Investigational Site

    Vitoria-Gasteiz, 01009

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

France29 sites

  • GSK Investigational Site

    Amiens, 80000

  • GSK Investigational Site

    Annecy, 74011

  • GSK Investigational Site

    Antony, 92160

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Cannes, 06414

  • GSK Investigational Site

    Cholet, 49300

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    La Tronche, 38700

  • GSK Investigational Site

    Le Mans, 72037

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Lyon, 69317

  • GSK Investigational Site

    Marseille, 13003.

  • GSK Investigational Site

    Marseille, 13015

  • GSK Investigational Site

    Montfermeil, 93370

  • GSK Investigational Site

    Montivilliers, 76290

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nice, 06001

  • GSK Investigational Site

    Paris, 75014

  • GSK Investigational Site

    Paris, 75015

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Pontoise, 95303

  • GSK Investigational Site

    Rouen, 76031

  • GSK Investigational Site

    Saint-Herblain, 44093

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Suresnes, 92150

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tours, 37044

Other trials in France

Germany28 sites

  • GSK Investigational Site

    Aschaffenburg, 63739

  • GSK Investigational Site

    Bendorf, 56170

  • GSK Investigational Site

    Berlin, 10969

  • GSK Investigational Site

    Berlin, 12159

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Bonn, 53119

  • GSK Investigational Site

    Bonn, 53127

  • GSK Investigational Site

    Darmstadt, 64283

  • GSK Investigational Site

    Frankfurt, 60389

  • GSK Investigational Site

    Frankfurt, 60596

  • GSK Investigational Site

    Fürstenwalde, 15517

  • GSK Investigational Site

    Geesthacht, 21502

  • GSK Investigational Site

    Halle, 06108

  • GSK Investigational Site

    Halle, 06120

  • GSK Investigational Site

    Hamburg, 20354

  • GSK Investigational Site

    Hanover, 30625

  • GSK Investigational Site

    Landsberg, 86899

  • GSK Investigational Site

    Leipzig, 04207

  • GSK Investigational Site

    Leipzig, 04275

  • GSK Investigational Site

    Leipzig, 04347

  • GSK Investigational Site

    Lübeck, 23552

  • GSK Investigational Site

    Lübeck, 23558

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Mainz, 55128

  • GSK Investigational Site

    München, 81241

  • GSK Investigational Site

    Neu-Isenburg, 63263

  • GSK Investigational Site

    Rheine, 48431

  • GSK Investigational Site

    Schleswig, 24837

Other trials in Germany

United Kingdom17 sites

  • GSK Investigational Site

    Belfast, BT9 7AB

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Bristol Avon, BS10 5NB

  • GSK Investigational Site

    Cottingham, HU16 5JQ

  • GSK Investigational Site

    Exeter, EX2 5DW

  • GSK Investigational Site

    Glasgow, G31 2ER

  • GSK Investigational Site

    Glasgow, G51 4TF

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    London, EC1A 7BE

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    Nottingham, NG5 1PB

  • GSK Investigational Site

    Oxford, OX3 9DU

  • GSK Investigational Site

    Portsmouth, PO6 3LY

  • GSK Investigational Site

    Preston, PR2 9HT

  • GSK Investigational Site

    Wakefield, WF1 4DG

  • GSK Investigational Site

    Wishaw, ML6 0JS

Other trials in United Kingdom

Australia16 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Bedford Park, South Australia, 5042

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Cairns, Queensland, 4870

  • GSK Investigational Site

    Clayton, Victoria, 3168

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Frankston, Victoria, 3199

  • GSK Investigational Site

    Macquarie University, New South Wales, 2109

  • GSK Investigational Site

    Melbourne, Victoria, 3181

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    North Adelaide, South Australia, 5006

  • GSK Investigational Site

    South Brisbane, Queensland, 4101

  • GSK Investigational Site

    Sydney, New South Wales, 2010

  • GSK Investigational Site

    Toorak Gardens, South Australia, 5065

  • GSK Investigational Site

    Westmead, New South Wales, 2145

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

Canada12 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Edmonton, Alberta, T5J 3S9

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Moncton, New Brunswick, E1C 5K4

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1E4

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Québec, Quebec, G1V 4W2

  • GSK Investigational Site

    Toronto, Ontario, M5G 1E2

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Netherlands10 sites

  • GSK Investigational Site

    Arnhem, 6815 AD

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Deventer, 7416 SE

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Enschede, 7513 ER

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Nijmegen, 6532 SZ

  • GSK Investigational Site

    Rotterdam, 3045 PM

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Israel9 sites

  • GSK Investigational Site

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Taiwan6 sites

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Sweden5 sites

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Switzerland4 sites

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Ireland3 sites

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Austria2 sites

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About this study

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

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.

Conditions
Asthma
Being tested
GSK3511294 (Depemokimab), Mepolizumab, Benralizumab, Placebo, Standard of care (SoC)
Keywords
Asthma, GSK3511294 (Depemokimab), Mepolizumab, Benralizumab, Interventional, Eosinophilic phenotype
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK3511294 (Depemokimab)Biological

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

  • MepolizumabBiological

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

  • BenralizumabBiological

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

  • PlaceboBiological

    Placebo will be a sterile liquid formulation.

  • Standard of care (SoC)Drug

    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)Device

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

Study groups in NCT04718389
Study groupRoleWhat they receive
Depemokimab 100mg SCExperimentalParticipants 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).
Receives: Biological: GSK3511294 (Depemokimab); Biological: Placebo; Drug: Standard of care (SoC); Device: Pre-filled Syringes (PFS)
Mepolizumab 100 mg / Benralizumab 30 mg SCActive 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.
Receives: Biological: Mepolizumab; Biological: Benralizumab; Biological: Placebo; Drug: Standard of care (SoC); Device: Pre-filled Syringes (PFS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Week 52

Secondary outcomes (3)

  1. Weighted Mean (WM) Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score

    SGRQ: validated, disease specific questionnaire comprising of 51 questions designed to measure health related quality of life in participants with disease of airway obstruction. It assesses how respiratory symptoms and limitations affect daily life. SGRQ 3 domains: Symptoms, Activity and, Impacts. Each item has an empirically derived weight, and domain scores are combined to produce a total score ranging: 0 to 100. Scores are expressed as a percentage of overall impairment between 100 (worst possible health status) and 0 (best possible health status). Higher scores indicating greater impairment of quality of life. Change from Baseline (CFB): value at indicated time point minus Baseline value. For each participant, WM CFB in SGRQ total score was calculated using linear trapezoidal rule to estimate area under the curve (AUC) from Baseline (Day 1) across Weeks 4, 12, 26, and 52 and presented as a single consolidated SGRQ total score on original scale (i.e., not expressed per unit time).

    Measured: From Baseline (Day 1) up to Week 52

  2. Weighted Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score

    The ACQ 5 is a validated, 5-item patient reported tool assessing asthma symptoms over the past week. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). Each item is scored from 0 (no impairment) to 6 (maximum impairment), and the final ACQ 5 score is the average of all items, ranging from 0 to 6. Lower scores indicate better asthma control, while higher scores indicate poorer control. CFB was defined as value at the indicated time point minus Baseline value. For each participant, the WM CFB in ACQ-5 score was calculated using the linear trapezoidal rule to estimate the AUC from Baseline (Day 1) across Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48 and 52) and presented as a single consolidated ACQ-5 score on the original scale (i.e., not expressed per unit/time).

    Measured: From Baseline (Day 1) up to Week 52

  3. Weighted Mean Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)

    Forced Expiratory Volume in One Second (FEV1) is defined as the volume of air that can be forced out in one second after taking a deep breath by a person and was measured by spirometry testing. Change from Baseline in clinic pre-bronchodilator FEV1 was determined. Change from Baseline was defined as value at the indicated time point minus Baseline value. For each participant, the WM change from baseline in FEV1 was calculated using the linear trapezoidal rule to estimate the AUC from Baseline (Day 1) across Weeks 12, 26, 40, and 52). WM change from baseline in FEV1 over 52-week period was presented as a single consolidated data.

    Measured: From Baseline (Day 1) up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start26 Jan 2021
  3. Primary completion14 Sep 2025
  4. Study completion14 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is randomized, double-blind, parallel group, multi-center and non-inferiority study.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,717 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718389
Sponsor's protocol ID
206785
Acronym
NIMBLE
Status last verified
Apr 2026
First submitted
18 Jan 2021
Last updated
18 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Chupp G, Nagase H, Skowasch D, Devouassoux G, Cote A, Jackson DJ, Jackson DJ, Wechsler ME, Imber V, McGinniss JE, O K S, 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 May 1;212(5):921-935. doi: 10.1093/ajrccm/aamag031.

    PubMed 41738176

  • Seluk 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.

    PubMed 39393433

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK3511294 (Depemokimab), Mepolizumab and Benralizumab in people with Asthma, run by GlaxoSmithKline at 397 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 397 sites in United States, Japan, Italy, Spain, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04718389, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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