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This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study (NCT04908865)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving belimumab + Standard of care (SOC) | Experimental | Participants will receive belimumab 200 milligrams SC injection according the Baseline body weight plus SOC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Biological | Belimumab will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Greater Than or Equal to (>=) 50 Kilograms (kg) | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of belimumab. AUCss,0-tau of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
| Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 30 kg and Less Than (<) 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 30 kg and < 50 kg has been reported. | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
| Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
| Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 | An AE is 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. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per medical and scientific judgement of the Investigator. AESIs defined in the protocol included post-injection systemic reactions and hypersensitivity reactions, infections of special interest, malignancies, and depression, suicidality, or self-injury. Number of participants with AEs, SAEs, and AESIs has been reported. |
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Inclusion Criteria:
Participants between 5 and 17 years of age inclusive, at the time of informed consent
Chinese pediatric participants with SLE, who have completed 48 weeks treatment in study 213560 and who, in the opinion of the investigator, may benefit from treatment with GSK1550188.
Body weight greater than equal to >=15 kilograms (kg), at the time of signing the informed consent.
Male and/or female:
i) Is a woman of non-childbearing potential OR ii) Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of <1%
Participant signs and dates a written age-appropriate assent form (in accordance with applicable regulations) and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent (including consent for the use and disclosure of research-related health information) that the participant will comply with the study protocol procedures (including required study visits).
Exclusion Criteria:
Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an Adverse events (AE) in 213560 study that could, in the opinion of the principal investigator, put the participant at undue risk.
Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions that, in the opinion of the principal investigator, makes the participant unsuitable for the study.
Have an estimated glomerular filtration rate as calculated by Schwartz Formula of less than 30 milliliter per minute (mL/min).
Have an Immunoglobulin A (IgA) deficiency (IgA level <10 milli gram per deciliter [mg/dL]).
Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
Developing a positive test for Human immunodeficiency virus (HIV) antibody after inclusion into 213560, per investigator's discretion according to clinical need.
Developing hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) OR Hepatitis B core antibody positive (HBcAb+) after inclusion into 213560, per investigator's discretion according to clinical need.
Developing a positive test for Hepatitis C antibody after inclusion into 213560, per investigator's discretion according to clinical need.
Have received a live or live-attenuated vaccine within 30 Days of Day 1.
Are unable or unlikely, in the opinion of the investigator, to administer belimumab by SC injection and have no reliable source to administer the injection.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GSK Clinical Trials | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beijing | 100045 | China | |||
| GSK Investigational Site |
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/
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.
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.
Participants who had completed 48 weeks of intravenous (IV) belimumab treatment in study 213560 (NCT04908865) were enrolled in this study.
A total of 16 participants were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belimumab 200 mg/mL | Participants with systemic lupus erythematosus (SLE), who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 milligrams per milliliter (mg/mL) as a subcutaneous (SC) injection over 12 weeks along with standard of care (SOC) therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing greater than or equal to (>=) 50 kilograms (kg) received belimumab every week, participants weighing between 30 kg and less than (<) 50 kg received belimumab every 10 days, and participants weighing between 15 kg and < 30 kg received belimumab every 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab 200 mg/mL | Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 mg/mL as an SC injection over 12 weeks along with SOC therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing >= 50 kg received belimumab every week, participants weighing between 30 kg and < 50 kg received belimumab every 10 days, and participants weighing between 15 kg and < 30 kg received belimumab every 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Greater Than or Equal to (>=) 50 Kilograms (kg) | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of belimumab. AUCss,0-tau of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*micrograms per milliliter | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
|
All-cause mortality, SAEs, and non-SAEs were collected up to 28 weeks (treatment: up to 12 weeks and follow-up: up to 16 weeks)
All-cause mortality, SAEs, and non-SAEs were analyzed for ITT Analysis Set that included all participants assigned treatment who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belimumab 200 mg/mL | Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 mg/mL as an SC injection over 12 weeks along with SOC therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing >= 50 kg received belimumab every week, participants weighing between 30 kg and < 50 kg received belimumab every 10 days, and participants weighing between 15 kg and < 30 kg received belimumab every 2 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2024 | Oct 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2024 | Oct 29, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511911 | belimumab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Drug | Standard of care will be administered |
|
| Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 30 kg and < 50 kg has been reported. | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
| Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
| Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
| Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 30 kg and < 50 kg has been reported. | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
| Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
| Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
| Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 30 kg and < 50 kg has been reported. | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
| Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
| Up to Week 12 |
| Changsha |
| 410007 |
| China |
| GSK Investigational Site | Hangzhou | 310052 | China |
| GSK Investigational Site | Nanjing | 210011 | China |
| GSK Investigational Site | Shanghai | 361006 | China |
| GSK Investigational Site | Suzhou | 215007 | China |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 30 kg and Less Than (<) 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 30 kg and < 50 kg has been reported. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*micrograms per milliliter | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
|
|
|
| Primary | Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*micrograms per milliliter | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
|
|
|
| Primary | Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
|
|
|
| Primary | Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 30 kg and < 50 kg has been reported. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
|
|
|
| Primary | Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
|
|
|
| Primary | Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
|
|
|
| Primary | Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 30 kg and < 50 kg has been reported. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
|
|
|
| Primary | Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
|
|
|
| Primary | Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 |
|
|
|
| Primary | Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 30 kg and < 50 kg has been reported. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 |
|
|
|
| Primary | Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. | PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 | An AE is 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. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per medical and scientific judgement of the Investigator. AESIs defined in the protocol included post-injection systemic reactions and hypersensitivity reactions, infections of special interest, malignancies, and depression, suicidality, or self-injury. Number of participants with AEs, SAEs, and AESIs has been reported. | Intent-to-Treat (ITT) Analysis Set included all participants assigned treatment who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 12 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 13 |
| 16 |
| Bronchitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Mycoplasma infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Noninfective gingivitis | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v27.1 | Systematic Assessment |
|
| Weight fluctuation | Metabolism and nutrition disorders | MedDRA v27.1 | Systematic Assessment |
|
| Growth retardation | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Measurements |
|---|
|