At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Belimumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Belimumab and Standard of care for Systemic Lupus Erythematosus. Completed, enrolled 16 participants across 6 sites.
Detailed Summary
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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedJun 2023
Enrollment StartJul 2023
Primary CompletionOct 2024
TodayJul 2026
First PostedJun 23, 2023
Enrollment StartJul 7, 2023
Primary CompletionOct 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.0 years ago
Interventions
Belimumabbiological
Belimumab will be administered
Standard of caredrug
Standard of care will be administered