A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Belimumab (GSK1550188) — BIOLOGICAL
  GSK1550188 will be administered subcutaneously.

Study Details

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 first-line SLE therapy.

Key Dates

Start date

Jun 6, 2024

Status verified

May 2026

Primary completion

May 31, 2027

Completion

May 29, 2029

Study Design

Enrollment

350 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Belimumab (GSK1550188)
  Participants will receive GSK1550188.

Primary Outcome Measure

Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52 [ Time Frame: At Week 52 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (46)

Find similar trials in Anniston, AL

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