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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04718389
Ethics application status
Date submitted
18/01/2021
Date registered
22/01/2021

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
Treatment: Other - GSK3511294 (Depemokimab)
Treatment: Other - Mepolizumab
Treatment: Other - Benralizumab
Treatment: Other - 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.


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

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

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

Treatment: Other: 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
Treatment: Other
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
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GSK Investigational Site - Westmead
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GSK Investigational Site - Cairns
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GSK Investigational Site - Bedford Park
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GSK Investigational Site - North Adelaide
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GSK Investigational Site - Toorak Gardens
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GSK Investigational Site - Woodville South
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GSK Investigational Site - Box Hill
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GSK Investigational Site - Clayton
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GSK Investigational Site - Fitzroy
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GSK Investigational Site - Frankston
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GSK Investigational Site - Prahran
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GSK Investigational Site - Nedlands
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2109 - Macquarie University
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2010 - Sydney
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2145 - Westmead
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4870 - Cairns
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4101 - South Brisbane
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5000 - Adelaide
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5042 - Bedford Park
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5006 - North Adelaide
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5065 - Toorak Gardens
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5011 - Woodville South
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3128 - Box Hill
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3168 - Clayton
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3065 - Fitzroy
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3199 - Frankston
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3181 - Prahran
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04718389