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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05243680




Registration number
NCT05243680
Ethics application status
Date submitted
8/02/2022
Date registered
17/02/2022

Titles & IDs
Public title
An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
Scientific title
A Multi-centre, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety of GSK3511294 (Depemokimab) in Adult and Adolescent Participants With Severe Asthma With an Eosinophilic Phenotype From Studies 206713 or 213744
Secondary ID [1] 0 0
212895
Universal Trial Number (UTN)
Trial acronym
AGILE
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)

Experimental: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab) -


Treatment: Other: GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks
Timepoint [1] 0 0
Up to Week 52
Primary outcome [2] 0 0
Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294 over 52 weeks
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Annualized rate of clinically significant exacerbations over 52 weeks
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [2] 0 0
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score over 52 weeks (Scores on a scale)
Timepoint [2] 0 0
Baseline (Day 1) and Up to Week 52
Secondary outcome [3] 0 0
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 (Scores on a scale)
Timepoint [3] 0 0
Baseline (Day 1), Week 26 and Week 52
Secondary outcome [4] 0 0
Change from Baseline in pre-bronchodilator Forced expiratory volume in one second (FEV1) at Week 26 and Week 52 (Liters)
Timepoint [4] 0 0
Baseline (Day 1), Week 26 and Week 52

Eligibility
Key inclusion criteria
Inclusion criteria:

* Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.
* Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
* A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded).
* Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.
* Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294.
* Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result:

1. Alanine aminotransferase (ALT) greater than (>)2 times upper limit of normal (ULN).
2. Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<] 35 percent [%]).
3. 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 must be excluded prior to enrolment.
* Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (>=)450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at Visit 1.
* Current smokers.
* Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.
* Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.
* Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.
* Other investigational product/clinical study:

1. Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term "investigational" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products.
2. Participants who are currently participating in any other interventional clinical study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/05/2025
Actual
Sample size
Target
Accrual to date
Final
641
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - South Brisbane
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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California
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Colorado
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Florida
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Georgia
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Illinois
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Kentucky
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Michigan
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Washington
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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China
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Changchun
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China
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Changsha
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China
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Chengdu
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China
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Guangzhou
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China
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Haikou
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China
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Hangzhou
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China
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Hefei
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Huhhot
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Jinan
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Shanghai
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China
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Shenyang
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China
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Urumqi
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China
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Wenzhou
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China
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Wuhan
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China
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Xuzhou
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Jindrichuv Hradec
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Czechia
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Olomouc
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Strakonice
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Tabor
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Teplice
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France
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France
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France
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Cholet
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France
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France
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Germany
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Berlin
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Frankfurt
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Hamburg
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Leipzig
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Magdeburg
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Mainz
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Germany
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Neu-Isenburg
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Hungary
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GOdOll?
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Hungary
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Mosonmagyarovar
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Hungary
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Szigetvar
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Brescia
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Foggia
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Messina
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Milano
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Monserrato CA
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Italy
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Palermo
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Italy
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Pavia
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Italy
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Roma
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Italy
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Rozzano MI
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Siena
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Aichi
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Niigata
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Lodz
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Lublin
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Ostrowiec Swietokrzyski
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Rzeszow
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Strzelce Opolskie
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Wroclaw
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Spain
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Barcelona
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BenalmAdena
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Spain
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Bilbao
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Gerona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Pozuelo De AlarcOn Madr
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Santander
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Santiago de Compostela
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Spain
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Valencia
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Spain
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Zaragoza
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
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Bradford
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United Kingdom
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Chertsey
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham

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
GSKClinicalSupportHD@gsk.com
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/NCT05243680