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

StatusActive, Not Recruiting
PhasePhase 4
Started

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Record History

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  1. Enrollment closed, study ongoingv12 Show 4 more changesShow less
    • Trial sites reduced: 114 → 109 locations
    • Final enrollment: 303 participants (planned 350)
    • Study completion pushed from May 29, 2029 to Jul 17, 2029
    • Primary completion date: May 31, 2027 to Jun 29, 2027
  2. Study sites: 113 to 114
    • Interventions: Belimumab (GSK1550188) (Drug) to Belimumab (GSK1550188) (Biological)
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints revised (10)
    v11
  3. Study sites: 100 to 113v10
  4. Site details revised at 3 of 100 sitesv9
  5. Study sites: 97 to 100v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 91 to 97v7
  2. Study sites: 82 to 91v6
  3. Study sites: 43 to 82
    • Eligibility criteria expanded, about 429 words
    • Secondary endpoints: 4 to 10
    v5
  4. Study sites: 18 to 43v4
  5. Study sites: 113 to 18
    • Primary completion date: Apr 19, 2027 to May 31, 2027
    • Start date changed from estimate of Jun 4, 2024 to Jun 6, 2024
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 113
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
Lupus (SLE)
669 trials monitored
See 29 trials at risk
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.
Trial Details
NCT Number NCT06411249
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Systemic Lupus Erythematosus
Related terms Autoimmune Diseases, Lupus Erythematosus, Systemic
Enrollment 303 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov