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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06079190




Registration number
NCT06079190
Ethics application status
Date submitted
6/10/2023
Date registered
12/10/2023

Titles & IDs
Public title
Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease
Scientific title
A Phase 2, Parallel Group, Randomized, Double- Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared With Placebo in Patients With Early Alzheimer's Disease
Secondary ID [1] 0 0
2023-505083-11-00
Secondary ID [2] 0 0
219867
Universal Trial Number (UTN)
Trial acronym
PROGRESS-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK4527226
Other interventions - Placebo

Experimental: GSK4527226 Dose 1 - Participants will receive GSK4527226 Dose 1

Experimental: GSK4527226 Dose 2 - Participants will receive GSK4527226 Dose 2

Placebo comparator: Placebo - Participants will receive placebo.


Treatment: Drugs: GSK4527226
GSK4527226 will be administered.

Other interventions: Placebo
Placebo will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Timepoint [1] 0 0
Baseline, Week 52, 64 and 76
Secondary outcome [1] 0 0
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Timepoint [1] 0 0
Baseline, Weeks 52, 64 and 76
Secondary outcome [2] 0 0
Change from Baseline in ADAS-Cog14 Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Timepoint [2] 0 0
Baseline, Weeks 52, 64 and 76
Secondary outcome [3] 0 0
Change from Baseline in ADCS-ADL-MCI Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Timepoint [3] 0 0
Baseline, Weeks 52, 64 and 76
Secondary outcome [4] 0 0
Change from Baseline in ADCS-iADL component of ADCS-ADL-MCI Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Timepoint [4] 0 0
Baseline, Weeks 52, 64 and 76
Secondary outcome [5] 0 0
Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Timepoint [5] 0 0
Baseline, Weeks 52, 64 and 76

Eligibility
Key inclusion criteria
Participant must be in the Alzheimer's continuum as defined by the 2018 National Institute on Aging and Alzheimer's Association (NIAAA) Research Framework corresponding to the clinical categories of MCI due to AD and mild AD dementia.

Participant must have evidence of amyloid positivity either by positive positron emission tomography (PET) result (Amyloid PET scans must be read by a central imaging lab) or cerebrospinal fluid (CSF) amyloid beta (Aß) test result indicative of amyloid positivity

* Participants must also meet the following criteria for clinical severity:

1. MMSE score of between 21 and 29 points
2. CDR-global score (GS) of 0.5 to 1.0.
3. CDR Memory Box score greater than or equal to (=) 0.5.
4. Participants with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale-IV Logical Memory II (WMS-IV LMII)
* If the participant is receiving symptomatic AD medications such as an Acetylcholinesterase inhibitor (AChEI) or memantine, the dosing regimen must have been stable for at least 12 weeks prior to screening and is not expected to change during study participation.
* If the participant is receiving other medications for AD related symptoms or associated conditions, the dosing regimen must have been stable for at least 4 weeks prior to screening and not expected to change during study participation. Symptoms must be considered adequately and stably controlled by the investigator, without marked changes in medication anticipated for the duration of the study.
* Body weight = 45 kilogram (kg) to less than or equal to (=)120 kg with body mass index (BMI) between 17 and 34.9 kilogram per meter square (kg/m^2), inclusive.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of child-bearing potential follows contraception requirements outlined in the protocol
* A male participant is eligible to participate if he follows contraception requirements outlined in the protocol
* Willing and able to give informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
* Availability of an adult person who has frequent and sufficient contact with the participant is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, and signs the ICF of the study partner.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant has evidence of any neurological condition other than AD that may contribute to cognitive impairment.

* History or presence of vascular disease that has the potential to affect cognitive function.
* History or presence of stroke within the past 1 year or recent transient ischemic attack within 180 days before screening.
* History of severe, clinically significant central nervous system (CNS) trauma.
* History or presence of intracranial tumor.
* Presence of ongoing infection(s) that may affect brain function, or history of infections that resulted in neurologic sequelae.
* History of primary psychiatric diagnosis that the investigator considers may interfere with study assessments.

Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, suicidal behaviour or has been assessed to be at risk of suicide, in the opinion of the investigator within 6 months before screening, at screening, or at the Baseline visit, or has been hospitalized or treated for suicidal behaviour in the past 2 years.

* Participant has history of alcohol and/or moderate to severe substance use disorder within the past 2 years
* Magnetic resonance imaging (MRI) evidence based on central read of:

1. >3 lacunar infarcts.
2. Stroke involving a major vascular territory, severe small vessel, or white matter disease.
3. Any territorial infarct >1 cubic centimetre (cm^3).
4. White matter hyperintense lesions on the FLAIR sequence that correspond to an overall Fazekas score of 3
5. >4 microhaemorrhages.
6. Any areas of superficial (leptomeningeal) hemosiderosis.
7. A single macro-hemorrhage greater than 10 millimetres (mm) at greatest diameter.
8. Vasogenic edema.
9. Cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions.
10. Space occupying lesions or brain tumors.
11. Significant cerebral vascular pathology
* History suggestive of exposure to, or past tuberculosis (TB) infection should undergo screening for TB disease.
* Chronic active immune disorder requiring systemic immunosuppressive therapy within 6 months prior to Screening.
* Screening serum vitamin B12 concentration < Lower limit of normal (LLN) or in the low normal range
* Folate <LLN or Thyroid-stimulating hormone (TSH) > Upper limit of normal (ULN)
* Hemoglobin A1c >8 percentage (%) or poorly controlled diabetes during the last 12 weeks
* History of cancer
* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
* Planned surgery during the study which requires general, spinal, or epidural anesthesia that would take place during the study.
* Key exclusionary medications include:

* Antipsychotics, opiates/opioids, cannabinoids, hypnotics, antidepressants, mood stabilizers, or stimulants that are used on a chronic basis, are exclusionary if not consistent with the following rule: treatment has to have been at a stable dose for at least 4 weeks before screening and should remain stable during the study
* Any biologic drugs with systemic exposure, whether investigational or approved, used within 6 months before screening Any disease modification drug for AD, such as aducanumab and lecanemab, whether investigational or approved, used within 6 months before screening.
* Anticoagulation medications within 90 days of screening and during the study
* Systemic immunosuppressive therapy within 90 days before screening and during the study.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
20/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/02/2029
Actual
Sample size
Target
282
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Kogarah
Recruitment hospital [4] 0 0
GSK Investigational Site - Macquarie Park
Recruitment hospital [5] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [6] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [7] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [8] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [5] 0 0
4222 - Gold Coast
Recruitment postcode(s) [6] 0 0
3079 - Heidelberg
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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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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Missouri
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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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United States of America
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Oklahoma
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Oregon
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South Carolina
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Ciudad Autonoma De Bueno
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Helsinki
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Finland
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Kuopio
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Finland
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Oulu
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Finland
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Turku
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France
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Bron
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France
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Lille Cedex
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France
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Nice
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France
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Paris
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France
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Saint-Herblain
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France
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Strasbourg
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France
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Toulouse
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France
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Villeurbanne
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Germany
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Erbach
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Germany
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Koeln
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Germany
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Muenchen
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Germany
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Muenster
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Italy
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Brescia
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Italy
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CefalU PA
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Italy
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Genova
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Italy
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Milano
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Italy
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Modena
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Italy
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Monza
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Italy
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Pavia
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Italy
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Perugia
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Italy
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Roma
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Korea, Republic of
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Jung Gu
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Den Bosch
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Netherlands
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Zwolle
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Stavanger
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Spain
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Barcelona
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Spain
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Getxo - Vizcaya
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Salamanca
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Spain
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San Sebastian
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Spain
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Terrassa - Barcelona
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Malmo
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Sweden
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Stockholm
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
State/province [66] 0 0
Tau-Yuan
Country [67] 0 0
Turkey
State/province [67] 0 0
Ankara
Country [68] 0 0
Turkey
State/province [68] 0 0
CapaIstanbul
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Birmingham
Country [70] 0 0
United Kingdom
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Bristol
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Glasgow
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London

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
Alector Inc.
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?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


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/NCT06079190