Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants

A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a Single Subcutaneous Dose of GSK3858279 Administered to Healthy Caucasian, Chinese and Japanese Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy Caucasian, Chinese and Japanese participants.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: GSK3858279

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston Queensland, Queensland, Australia, 4006
      • GSK Investigational Site
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent.
• Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Participants who have evidence of completed vaccination for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine.
• Body weight within the range 45 - 100 killogram (kg) and body mass index (BMI) within the range 18-29.9 kg per meter square (/m2) (inclusive).
• Japanese participants are eligible based on meeting all of the following:
• Participants born in Japan
• Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents.
• Have lived outside Japan for less than (<) 10 years at the time of screening
• Chinese participants are eligible based on meeting all of the following
• Participants born in mainland China, Hong Kong or Taiwan
• Descendants of four Chinese grandparents and two Chinese parents
• Have lived outside China, Hong Kong or Taiwan for <10 years at the time of screening
• Caucasian participants are eligible based on meeting the following
• Declaration of familial Caucasian/European ancestry (having 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry)
• Male or female participant
• Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
• A female participant is eligible to participate if she is of non-reproductive potential.
• Capable of giving signed informed consent.

Exclusion Criteria:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• Personal or family history of cardiomyopathy.
• Abnormal blood pressure at screening as determined by the investigator.
• History of symptomatic herpes zoster.
• Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
• Significant allergies to humanized monoclonal antibodies as per principal investigator's and GSK medical monitor's judgements.
• History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
• History of lymphoma, leukaemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.

ALT greater than (>)1.5 times upper limit of normal (ULN) .

• Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Corrected QT (QTc) >450 milliseconds (msec).
• History of Stevens Johnson Syndrome.
• Known immunodeficiency.
• Participants with a chronic infection (for example [e.g.], osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
• Previous or current history of bleeding diathesis, excessive bleeding or coagulation disorders.
• History of significant medical illness in the opinion of the investigator would interfere with the study procedures and / or assessments.
• Intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing until final follow-up visit.
• Live vaccine(s) or plans to receive such vaccines within 1 month of screening until final follow-up visit.
• Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
• Treatment with antiplatelet or anticoagulant agents within 7 days of dosing.
• Major surgery (as per investigator's judgement) within 3 months prior to dosing.
• Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months.
• Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
• Current enrolment or past participation in any other clinical study involving an investigational drug intervention within the last 3 months or 5 half-lives (whichever is longer) of signing the ICF.
• Presence of Hepatitis B surface antigen (HBsAg) at screening.
• Presence of the Hepatitis B core antibody (HBcAb) at screening.
• Positive Hepatitis C antibody test result at screening.
• Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
• Abnormal clinically significant echocardiogram at screening, as assessed by the investigator.
• Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out of normal range at screening.
• Positive pre-study drug/alcohol screen.
• Positive human immunodeficiency virus (HIV) antibody test.
• Positive coronavirus disease 2019 (COVID-19): SARS-CoV2 polymerase chain reaction (PCR) or lateral flow test of a combined throat and nasopharyngeal swab or nasal swab only.
• Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 units for males and >14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
• Regular use of known drugs of abuse.
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK3858279 Caucasian; Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	Drug: GSK3858279; GSK3858279 will be administered
Experimental: GSK3858279 Chinese; Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	Drug: GSK3858279; GSK3858279 will be administered
Experimental: GSK3858279 Japanese; Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Drug: GSK3858279; GSK3858279 will be administered
Placebo Comparator: Caucasian Placebo; Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Drug: Placebo; Placebo will be administered
Placebo Comparator: Chinese Placebo; Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Drug: Placebo; Placebo will be administered
Placebo Comparator: Japanese Placebo; Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.	Drug: Placebo; Placebo will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.	Up to 169 days
Change From Baseline in Hematology Parameter of Platelet Count	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Hematology Parameter of Hemoglobin	Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Hematology Parameter of Hematocrit	Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Total Protein	Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.	Baseline and Day 169
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.	Baseline and Day 169
Number of Participants With Abnormal Urinalysis Results by Dipstick Method	The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.	Baseline and Day 169
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Vital Signs: Pulse Rate	The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Vital Signs: Body Temperature	The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Vital Signs: Respiratory Rate	The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.	Baseline and Day 169
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.	Baseline and Day 169
Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Maximum Observed Concentration (Cmax) of GSK3858279	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Time of Occurrence of Cmax (Tmax) of GSK3858279	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in Free CCL17	Blood samples were collected from participants at time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Cmax of Total CCL17 in Serum Following GSK3858279	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Tmax of Total CCL17 in Serum Following GSK3858279	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.	Baseline (Day 1) and Days 56 Post dose
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA). The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.	Day 169
Number of Participants With Treatment-Emergent ADA's Over Time	Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA).The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.	Day 169

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Chinese; Pharmacokinetics; Japanese; Tolerability; Placebo; Caucasian; GSK3858279
• Other Study ID Numbers: 212979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No