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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04718103




Registration number
NCT04718103
Ethics application status
Date submitted
18/01/2021
Date registered
22/01/2021
Date last updated
17/10/2023

Titles & IDs
Public title
A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype
Scientific title
A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype
Secondary ID [1] 0 0
213744
Universal Trial Number (UTN)
Trial acronym
SWIFT-2
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 - Placebo

Experimental: Participants receiving GSK3511294 (Depemokimab) -

Placebo Comparator: Participants receiving Placebo -


Other interventions: GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled syringe.

Other interventions: Placebo
Placebo will be administered as normal saline using a pre-filled syringe.
Intervention code [1] 0 0
Other interventions
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
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 52
Timepoint [1] 0 0
Baseline (Day 1) and at Week 52
Secondary outcome [2] 0 0
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at Week 52
Timepoint [2] 0 0
Baseline (Day 1) and at Week 52
Secondary outcome [3] 0 0
Change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at Week 52
Timepoint [3] 0 0
Baseline (Day 1) and at Week 52
Secondary outcome [4] 0 0
Annualized rate of exacerbations requiring hospitalization and/or Emergency Department (ED) visit over 52 weeks
Timepoint [4] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
Key inclusion criteria for study:

- Adults and adolescents greater than or equal to (>=)12 years of age, at the time of
signing the informed consent/assent.

- Participants must 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 and

1. Eosinophilic phenotype: participants who have, or with high likelihood of having,
asthma with an eosinophilic phenotype as per randomization criteria, and

2. Exacerbation history: participants who have previously confirmed history of >=2
exacerbations requiring treatment with systemic corticosteroid (CS)
(Intramuscular [IM], Intravenous [IV], or oral), in the 12 months prior to Visit
1, despite the use of medium to high-dose ICS. For participants receiving
maintenance CS, the CS treatment for the exacerbations must have been a two-fold
dose increase or greater.

- Persistent airflow obstruction as indicated by (i) For participants >=18 years of age
at Visit 1, a pre-bronchodilator FEV1 less than (<)80 percent (%) predicted National
Health and Nutrition Examination Survey (NHANES III) recorded at Visit 1.

(ii) For participants 12-17 years of age at Visit 1: A pre-bronchodilator FEV1 <90%
predicted (NHANES III) recorded at Visit 1 or FEV1: Forced Vital Capacity (FVC) ratio <0.8
recorded at Visit 1.

- 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 fluticasone propionate (FP) hydrofluoroalkane product
(HFA) daily, or clinically comparable (GINA, 2020). Participants who are treated with
medium dose ICS will also need to be treated with LABA to qualify for inclusion.

- Current treatment with at least one additional controller medication, besides ICS, for
at least 3 months (for example [e.g.], LABA, LAMA, leukotriene receptor antagonist
[LTRA], or theophylline).

Key inclusion criteria for randomization:

- An elevated peripheral blood eosinophil count of >=300 cells per microliter
demonstrated in the past 12 months prior to Visit 1 that is related to asthma or an
elevated peripheral blood eosinophil count of >=150 cells per microliter at Screening
Visit 1 that is related to asthma.

- Evidence of airway reversibility or responsiveness as documented by either:

(i) Airway reversibility (FEV1>=12% and 200 milliliter [mL]) demonstrated at Visit 1
or Visit 2 using the Maximum Post Bronchodilator Procedure or (ii) Airway
reversibility (FEV1>=12% and 200 mL) documented in the 24 months prior to Visit 2
(randomization visit) or (iii) Airway hyper-responsiveness (methacholine: Provocative
concentration causing a 20% fall in FEV1 [PC20] of <8 milligrams per milliliter
(mg/mL), histamine: Provocative dose that decreases FEV1 by 20% [PD20] of <7.8
micromoles, mannitol: decrease in FEV1 as per the labelled product instructions)
documented in the 24 months prior to Visit 2 (randomization visit).

Key exclusion criteria for study:

- 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 who have known, pre-existing, clinically significant cardiac, endocrine,
autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological
or any other system abnormalities that are uncontrolled with standard treatment.

- Participants with current diagnosis of vasculitis. Participants with high clinical
suspicion of vasculitis at screening will be evaluated and current vasculitis must be
excluded prior to enrolment.

- Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or
benralizumab (Fasenra) within 12 months prior to Visit 1 or who have a previous
documented failure with Anti-Interleukin-5/Anti-Interleukin-5 receptor (anti-IL-5/5R)
therapy.

- Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130
days prior to Visit 1.

- Participants who have received any monoclonal antibody (mAb) within 5 half-lives of
Visit 1.

- Previously participated in any study with mepolizumab, reslizumab, or benralizumab and
received study intervention (including placebo) within 12 months prior to 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 = [number of cigarettes per day/ 20] multiplied by 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 the excipients of GSK3511294 or any mAb or
biologic.

Key exclusion criteria for randomization:

- QTcF >= 450 msec or QTcF >=480 msec for participants with Bundle Branch Block, at
randomization Visit 2 are excluded. Participants are excluded if an abnormal
Electrocardiogram (ECG) finding from the 12-lead ECG conducted at Screening Visit 1 is
considered to be clinically significant and would impact the participant's
participation during the study, based on the evaluation of the Investigator.

- 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.

- 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/04/2024
Actual
Sample size
Target
Accrual to date
Final
397
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
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
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Colorado
Country [5] 0 0
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Missouri
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New Jersey
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United States of America
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New York
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North Carolina
Country [15] 0 0
United States of America
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Ohio
Country [16] 0 0
United States of America
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Oklahoma
Country [17] 0 0
United States of America
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Pennsylvania
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United States of America
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South Dakota
Country [19] 0 0
United States of America
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Tennessee
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Texas
Country [21] 0 0
United States of America
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Washington
Country [22] 0 0
United States of America
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Wisconsin
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Czechia
State/province [27] 0 0
Tabor
Country [28] 0 0
Czechia
State/province [28] 0 0
Teplice
Country [29] 0 0
France
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Annecy Cedex
Country [30] 0 0
France
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Caen
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France
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Cannes Cedex
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France
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Marseille
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France
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Paris
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France
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Strasbourg Cedex
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Hungary
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Debrecen
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Hungary
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Gödöllo
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Hungary
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Hajdunanas
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Hungary
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Mosonmagyarovar
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Hungary
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Szigetvar
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Hungary
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Szombathely
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Italy
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Campania
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Italy
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Friuli-Venezia-Giulia
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Italy
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Liguria
Country [44] 0 0
Italy
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Lombardia
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Italy
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Puglia
Country [46] 0 0
Italy
State/province [46] 0 0
Sardegna
Country [47] 0 0
Italy
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Sicilia
Country [48] 0 0
Italy
State/province [48] 0 0
Toscana
Country [49] 0 0
Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
Country [52] 0 0
Japan
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Fukui
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Japan
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Fukuoka
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Japan
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Fukushima
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kagawa
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Saga
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Japan
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Shizuoka
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Japan
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Tokyo
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Ostrowiec Swietokrzyski
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Poland
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Rzeszow
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Poland
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Wroclaw
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Poland
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Zawadzkie
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Spain
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Madrid
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Basurto/Bilbao
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Spain
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Benalmádena
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Spain
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Elche
Country [78] 0 0
Spain
State/province [78] 0 0
Esplugues de Llobregat
Country [79] 0 0
Spain
State/province [79] 0 0
Gerona
Country [80] 0 0
Spain
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Jerez de la Frontera
Country [81] 0 0
Spain
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Málaga
Country [82] 0 0
Spain
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Santander
Country [83] 0 0
Spain
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Santiago de Compostela
Country [84] 0 0
Spain
State/province [84] 0 0
Sán Crístobál De Lá Láguná
Country [85] 0 0
Spain
State/province [85] 0 0
Valencia
Country [86] 0 0
Spain
State/province [86] 0 0
Zaragoza
Country [87] 0 0
Taiwan
State/province [87] 0 0
Changhua
Country [88] 0 0
Taiwan
State/province [88] 0 0
Kaohsiung
Country [89] 0 0
Taiwan
State/province [89] 0 0
New Taipei City
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taichung
Country [91] 0 0
Taiwan
State/province [91] 0 0
Tainan
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taipei
Country [93] 0 0
Taiwan
State/province [93] 0 0
Taoyuan

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 the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive
therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04718103
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries