A Phase 4, multicenter, prospective, open-label study describing the efficacy and safety of belimumab administered subcutaneously in adult participants with early systemic lupus erythematosus

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509146-35-00

Acronym

219240

Enrollment

Registered

2024-10-08

Start date

2025-01-30

Completion date

Unknown

Last updated

2026-01-22

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

Achieving LLDAS at Week 52.

Detailed description

Achieving SRI4 at Week 52., Achieving LLDAS for ≥25% of time from Day 1 to Week 52., Achieving average oral prednisone equivalent dose ≤5 mg/day at Week 52., Incidence of severe flare (modified SFI) as assessed at Week 52., Part B: Achieving DORIS remission at Week 104., Part B: Maintaining an SDI of 0 at Week 156., Part B: Incidence of AEs, SAEs and AESI up to Week 104 and up to Week 156.

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achieving LLDAS at Week 52.	—

Secondary

Measure	Time frame
Achieving SRI4 at Week 52., Achieving LLDAS for ≥25% of time from Day 1 to Week 52., Achieving average oral prednisone equivalent dose ≤5 mg/day at Week 52., Incidence of severe flare (modified SFI) as assessed at Week 52., Part B: Achieving DORIS remission at Week 104., Part B: Maintaining an SDI of 0 at Week 156., Part B: Incidence of AEs, SAEs and AESI up to Week 104 and up to Week 156.	—

Countries

France, Germany, Greece, Italy, Portugal, Spain

Outcome results

None listed

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