Belimumab
BiologicalBelimumab will be administered
NCT Number: NCT05917288
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)
Looking for future studies?
Notify Me5 year–17 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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%
Exclusion criteria
Belimumab will be administered
Standard of care will be administered
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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.
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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.
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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.
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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.
Time frame: Up to 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.
GlaxoSmithKline
Industry
A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Systemic Lupus Erythematosus (SLE)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial DetailsNCT00055055
Arthritis, Arthritis, Rheumatoid
Bethesda, Maryland, United States
View Trial DetailsNCT03738826
Autoimmune Diseases, Behavior
Durham, North Carolina, United States
View Trial DetailsNCT06759519
Autoimmune Diseases, Connective Tissue Diseases
Barnaul, Russia
View Trial Details