A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509413-37-00

Acronym

200908

Enrollment

Registered

2024-03-15

Start date

2020-01-17

Completion date

2025-10-23

Last updated

2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief summary

Observed belimumab concentrations at Week 12., Steady-state PK parameters: Cavg (AUC), Cmax, Cmin (based on population PK estimates).

Detailed description

Incidence of adverse events, serious adverse events and adverse events of special interest through Week 52., "Change from baseline in biomarkers (C3/C4, anti-dsDNA, B cell subsets, and immunoglobulins) at Weeks 12 and 52."

Interventions

DRUGBenlysta 200 mg solution for injection in pre-filled pen.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Observed belimumab concentrations at Week 12., Steady-state PK parameters: Cavg (AUC), Cmax, Cmin (based on population PK estimates).	—

Secondary

Measure	Time frame
Incidence of adverse events, serious adverse events and adverse events of special interest through Week 52., "Change from baseline in biomarkers (C3/C4, anti-dsDNA, B cell subsets, and immunoglobulins) at Weeks 12 and 52."	—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026