Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04718389




Registration number
NCT04718389
Ethics application status
Date submitted
18/01/2021
Date registered
22/01/2021
Date last updated
30/04/2024

Titles & IDs
Public title
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
Scientific 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
Secondary ID [1] 0 0
206785
Universal Trial Number (UTN)
Trial acronym
NIMBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GSK3511294 (Depemokimab)
Other interventions - Mepolizumab
Other interventions - Benralizumab
Other interventions - Placebo
Treatment: Drugs - Standard of care (SoC)
Treatment: Devices - Pre-filled Syringes (PFS)

Experimental: Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment - Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor [anti-IL-5/5R] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.

Active Comparator: Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab) - Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.


Other interventions: GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS).

Other interventions: Mepolizumab
Mepolizumab will be provided in a single-use PFS.

Other interventions: Benralizumab
Benralizumab will be provided in a single-use PFS.

Other interventions: Placebo
Placebo will be a sterile liquid formulation.

Treatment: Drugs: 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).

Treatment: Devices: Pre-filled Syringes (PFS)
PFS will include glass barrel with pre-staked needle and plunger.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized rate of clinically significant exacerbations over 52 weeks
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Weighted mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score
Timepoint [1] 0 0
Baseline (Day 1) and up to Week 52
Secondary outcome [2] 0 0
Weighted mean change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score
Timepoint [2] 0 0
Baseline (Day 1) and up to Week 52
Secondary outcome [3] 0 0
Weighted mean change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Timepoint [3] 0 0
Baseline (Day 1) and up to Week 52

Eligibility
Key inclusion criteria
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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/09/2025
Actual
Sample size
Target
1700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Macquarie University
Recruitment hospital [2] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [3] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [4] 0 0
GSK Investigational Site - Cairns
Recruitment hospital [5] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [6] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [7] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [8] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [9] 0 0
GSK Investigational Site - Toorak Gardens
Recruitment hospital [10] 0 0
GSK Investigational Site - Woodville South
Recruitment hospital [11] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [12] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [13] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [14] 0 0
GSK Investigational Site - Frankston
Recruitment hospital [15] 0 0
GSK Investigational Site - Prahran
Recruitment hospital [16] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
5006 - North Adelaide
Recruitment postcode(s) [9] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [10] 0 0
5011 - Woodville South
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
3065 - Fitzroy
Recruitment postcode(s) [14] 0 0
3199 - Frankston
Recruitment postcode(s) [15] 0 0
3181 - Prahran
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New Mexico
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
Wisconsin
Country [36] 0 0
Austria
State/province [36] 0 0
Feldbach
Country [37] 0 0
Austria
State/province [37] 0 0
Wien
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
New Brunswick
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Finland
State/province [42] 0 0
Tampere
Country [43] 0 0
Finland
State/province [43] 0 0
Turku
Country [44] 0 0
France
State/province [44] 0 0
Amiens
Country [45] 0 0
France
State/province [45] 0 0
Annecy Cedex
Country [46] 0 0
France
State/province [46] 0 0
Antony
Country [47] 0 0
France
State/province [47] 0 0
Besançon
Country [48] 0 0
France
State/province [48] 0 0
Brest Cedex
Country [49] 0 0
France
State/province [49] 0 0
Brest cedex
Country [50] 0 0
France
State/province [50] 0 0
Caen
Country [51] 0 0
France
State/province [51] 0 0
Cannes Cedex
Country [52] 0 0
France
State/province [52] 0 0
Cholet
Country [53] 0 0
France
State/province [53] 0 0
Dijon Cedex
Country [54] 0 0
France
State/province [54] 0 0
La Tronche
Country [55] 0 0
France
State/province [55] 0 0
Le Mans Cedex
Country [56] 0 0
France
State/province [56] 0 0
Lille Cedex
Country [57] 0 0
France
State/province [57] 0 0
Lille cedex
Country [58] 0 0
France
State/province [58] 0 0
Lyon cedex 04
Country [59] 0 0
France
State/province [59] 0 0
Marseille
Country [60] 0 0
France
State/province [60] 0 0
Montfermeil
Country [61] 0 0
France
State/province [61] 0 0
Montivilliers
Country [62] 0 0
France
State/province [62] 0 0
Montpellier Cedex 5
Country [63] 0 0
France
State/province [63] 0 0
Nantes cedex
Country [64] 0 0
France
State/province [64] 0 0
Nice cedex 1
Country [65] 0 0
France
State/province [65] 0 0
Paris cedex 15
Country [66] 0 0
France
State/province [66] 0 0
Paris Cedex 18
Country [67] 0 0
France
State/province [67] 0 0
Paris
Country [68] 0 0
France
State/province [68] 0 0
Pontoise
Country [69] 0 0
France
State/province [69] 0 0
Rouen cedex
Country [70] 0 0
France
State/province [70] 0 0
Strasbourg
Country [71] 0 0
France
State/province [71] 0 0
Suresnes
Country [72] 0 0
France
State/province [72] 0 0
Toulouse
Country [73] 0 0
France
State/province [73] 0 0
Tours cedex 9
Country [74] 0 0
Germany
State/province [74] 0 0
Baden-Wuerttemberg
Country [75] 0 0
Germany
State/province [75] 0 0
Bayern
Country [76] 0 0
Germany
State/province [76] 0 0
Brandenburg
Country [77] 0 0
Germany
State/province [77] 0 0
Hessen
Country [78] 0 0
Germany
State/province [78] 0 0
Niedersachsen
Country [79] 0 0
Germany
State/province [79] 0 0
Nordrhein-Westfalen
Country [80] 0 0
Germany
State/province [80] 0 0
Rheinland-Pfalz
Country [81] 0 0
Germany
State/province [81] 0 0
Sachsen-Anhalt
Country [82] 0 0
Germany
State/province [82] 0 0
Sachsen
Country [83] 0 0
Germany
State/province [83] 0 0
Schleswig-Holstein
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Bonn
Country [86] 0 0
Germany
State/province [86] 0 0
Hamburg
Country [87] 0 0
Germany
State/province [87] 0 0
Magdeburg
Country [88] 0 0
Ireland
State/province [88] 0 0
Cork
Country [89] 0 0
Ireland
State/province [89] 0 0
Dublin
Country [90] 0 0
Israel
State/province [90] 0 0
Beer Sheva
Country [91] 0 0
Israel
State/province [91] 0 0
Haifa
Country [92] 0 0
Israel
State/province [92] 0 0
Jerusalem
Country [93] 0 0
Israel
State/province [93] 0 0
Kfar Saba
Country [94] 0 0
Israel
State/province [94] 0 0
Petah Tikva
Country [95] 0 0
Israel
State/province [95] 0 0
Ramat-Gan
Country [96] 0 0
Israel
State/province [96] 0 0
Tel Aviv
Country [97] 0 0
Israel
State/province [97] 0 0
Zrifin
Country [98] 0 0
Italy
State/province [98] 0 0
Campania
Country [99] 0 0
Italy
State/province [99] 0 0
Emilia-Romagna
Country [100] 0 0
Italy
State/province [100] 0 0
Friuli-Venezia-Giulia
Country [101] 0 0
Italy
State/province [101] 0 0
Lazio
Country [102] 0 0
Italy
State/province [102] 0 0
Liguria
Country [103] 0 0
Italy
State/province [103] 0 0
Lombardia
Country [104] 0 0
Italy
State/province [104] 0 0
Marche
Country [105] 0 0
Italy
State/province [105] 0 0
Piemonte
Country [106] 0 0
Italy
State/province [106] 0 0
Puglia
Country [107] 0 0
Italy
State/province [107] 0 0
Sardegna
Country [108] 0 0
Italy
State/province [108] 0 0
Sicilia
Country [109] 0 0
Italy
State/province [109] 0 0
Toscana
Country [110] 0 0
Italy
State/province [110] 0 0
Umbria
Country [111] 0 0
Italy
State/province [111] 0 0
Veneto
Country [112] 0 0
Italy
State/province [112] 0 0
Padova
Country [113] 0 0
Japan
State/province [113] 0 0
Aichi
Country [114] 0 0
Japan
State/province [114] 0 0
Akita
Country [115] 0 0
Japan
State/province [115] 0 0
Ehime
Country [116] 0 0
Japan
State/province [116] 0 0
Fukuoka
Country [117] 0 0
Japan
State/province [117] 0 0
Fukushima
Country [118] 0 0
Japan
State/province [118] 0 0
Gifu
Country [119] 0 0
Japan
State/province [119] 0 0
Hiroshima
Country [120] 0 0
Japan
State/province [120] 0 0
Hokkaido
Country [121] 0 0
Japan
State/province [121] 0 0
Hyogo
Country [122] 0 0
Japan
State/province [122] 0 0
Ibaraki
Country [123] 0 0
Japan
State/province [123] 0 0
Ishikawa
Country [124] 0 0
Japan
State/province [124] 0 0
Iwate
Country [125] 0 0
Japan
State/province [125] 0 0
Kagawa
Country [126] 0 0
Japan
State/province [126] 0 0
Kagoshima
Country [127] 0 0
Japan
State/province [127] 0 0
Kanagawa
Country [128] 0 0
Japan
State/province [128] 0 0
Mie
Country [129] 0 0
Japan
State/province [129] 0 0
Miyagi
Country [130] 0 0
Japan
State/province [130] 0 0
Nagano
Country [131] 0 0
Japan
State/province [131] 0 0
Niigata
Country [132] 0 0
Japan
State/province [132] 0 0
Okayama
Country [133] 0 0
Japan
State/province [133] 0 0
Osaka
Country [134] 0 0
Japan
State/province [134] 0 0
Shimane
Country [135] 0 0
Japan
State/province [135] 0 0
Shizuoka
Country [136] 0 0
Japan
State/province [136] 0 0
Tochigi
Country [137] 0 0
Japan
State/province [137] 0 0
Tokyo
Country [138] 0 0
Japan
State/province [138] 0 0
Toyama
Country [139] 0 0
Japan
State/province [139] 0 0
Wakayama
Country [140] 0 0
Netherlands
State/province [140] 0 0
Arnhem
Country [141] 0 0
Netherlands
State/province [141] 0 0
Breda
Country [142] 0 0
Netherlands
State/province [142] 0 0
Deventer
Country [143] 0 0
Netherlands
State/province [143] 0 0
Eindhoven
Country [144] 0 0
Netherlands
State/province [144] 0 0
Enschede
Country [145] 0 0
Netherlands
State/province [145] 0 0
Harderwijk
Country [146] 0 0
Netherlands
State/province [146] 0 0
Leeuwarden
Country [147] 0 0
Netherlands
State/province [147] 0 0
Nijmegen
Country [148] 0 0
Netherlands
State/province [148] 0 0
Rotterdam
Country [149] 0 0
Netherlands
State/province [149] 0 0
Zwolle
Country [150] 0 0
Norway
State/province [150] 0 0
Bergen
Country [151] 0 0
Norway
State/province [151] 0 0
Lørenskog
Country [152] 0 0
Portugal
State/province [152] 0 0
Coimbra
Country [153] 0 0
Portugal
State/province [153] 0 0
Guarda
Country [154] 0 0
Portugal
State/province [154] 0 0
Lisboa
Country [155] 0 0
Portugal
State/province [155] 0 0
Matosinhos
Country [156] 0 0
Portugal
State/province [156] 0 0
Porto
Country [157] 0 0
Puerto Rico
State/province [157] 0 0
Guaynabo
Country [158] 0 0
Slovenia
State/province [158] 0 0
Golnik
Country [159] 0 0
Spain
State/province [159] 0 0
Madrid
Country [160] 0 0
Spain
State/province [160] 0 0
Alcorcón (Madrid)
Country [161] 0 0
Spain
State/province [161] 0 0
Almería
Country [162] 0 0
Spain
State/province [162] 0 0
Badalona
Country [163] 0 0
Spain
State/province [163] 0 0
Barcelona
Country [164] 0 0
Spain
State/province [164] 0 0
Basurto/Bilbao
Country [165] 0 0
Spain
State/province [165] 0 0
Benalmádena
Country [166] 0 0
Spain
State/province [166] 0 0
Elche
Country [167] 0 0
Spain
State/province [167] 0 0
Esplugues de Llobregat
Country [168] 0 0
Spain
State/province [168] 0 0
Granada
Country [169] 0 0
Spain
State/province [169] 0 0
Jerez de la Frontera
Country [170] 0 0
Spain
State/province [170] 0 0
Málaga
Country [171] 0 0
Spain
State/province [171] 0 0
Mérida (Badajoz)
Country [172] 0 0
Spain
State/province [172] 0 0
Pamplona
Country [173] 0 0
Spain
State/province [173] 0 0
Salamanca
Country [174] 0 0
Spain
State/province [174] 0 0
Santander
Country [175] 0 0
Spain
State/province [175] 0 0
Santiago De Compostela. La Coruña.
Country [176] 0 0
Spain
State/province [176] 0 0
Sán Crístobál De Lá Láguná
Country [177] 0 0
Spain
State/province [177] 0 0
Valencia
Country [178] 0 0
Spain
State/province [178] 0 0
Via-Real (Castellón)
Country [179] 0 0
Spain
State/province [179] 0 0
Vitoria - Gasteiz
Country [180] 0 0
Spain
State/province [180] 0 0
Zaragoza
Country [181] 0 0
Sweden
State/province [181] 0 0
Linköping
Country [182] 0 0
Sweden
State/province [182] 0 0
Lund
Country [183] 0 0
Sweden
State/province [183] 0 0
Stockholm
Country [184] 0 0
Sweden
State/province [184] 0 0
Uppsala
Country [185] 0 0
Sweden
State/province [185] 0 0
Östersund
Country [186] 0 0
Switzerland
State/province [186] 0 0
Aarau
Country [187] 0 0
Switzerland
State/province [187] 0 0
Basel
Country [188] 0 0
Switzerland
State/province [188] 0 0
Liestal
Country [189] 0 0
Switzerland
State/province [189] 0 0
St. Gallen
Country [190] 0 0
Taiwan
State/province [190] 0 0
Changhua
Country [191] 0 0
Taiwan
State/province [191] 0 0
Gueishan Township,Taoyuan County
Country [192] 0 0
Taiwan
State/province [192] 0 0
Taichung
Country [193] 0 0
Taiwan
State/province [193] 0 0
Taipei
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Gloucestershire
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Lanarkshire
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Merseyside
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Nottinghamshire
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Belfast
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Birmingham
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Bradford
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Cottingham, East Yorkshire
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Edinburgh
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Exeter.
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Glasgow
Country [205] 0 0
United Kingdom
State/province [205] 0 0
London
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Newcastle Upon Tyne
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Oxford
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Portsmouth
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Preston
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Wakefield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04718389
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04718389