Trials / Recruiting
RecruitingNCT06411249
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belimumab (GSK1550188) | GSK1550188 will be administered subcutaneously. |
Timeline
- Start date
- 2024-06-06
- Primary completion
- 2027-05-31
- Completion
- 2029-05-29
- First posted
- 2024-05-13
- Last updated
- 2025-11-26
Locations
113 sites across 11 countries: United States, Argentina, Brazil, France, Germany, Greece, Italy, Japan, Mexico, Portugal, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06411249. Inclusion in this directory is not an endorsement.