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Synergetic B-cell Immunomodulation in SLE - 2nd Study.

Study acronym: SynBioSe-2
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Jun 7, 2024 to Jun 22, 2026 Trial completed · Enrollment target: estimated 70 to confirmed 71 · Study completion date changed from estimate of Jun 7, 2026 to Jun 22, 2026 · 3 more Show 6 more changesShow less
    • Trial completed
    • Enrollment target: estimated 70 to confirmed 71
    • Study completion date changed from estimate of Jun 7, 2026 to Jun 22, 2026
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 2 of 14 entries
    • Publications: details revised at 2 of 2 entries
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Dec 2023 to Jun 7, 2024 · Completion date: Sep 2025 to Jun 7, 2026 · Site details revised at 4 of 4 sitesv7 Show 3 more changesShow less
    • Primary completion date changed from estimate of Dec 2023 to Jun 7, 2024
    • Completion date: Sep 2025 to Jun 7, 2026
    • Site details revised at 4 of 4 sites
  3. Primary completion date: Sep 2023 to Dec 2023v6
  4. Phase: Phase 2 to Phase 3 Secondary endpoints revised (14) · Site details revised at 3 of 4 sitesv5 Show 2 more changesShow less
    • Secondary endpoints revised (14)
    • Site details revised at 3 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoint revised Secondary endpoints revised (14)v4 Show 1 more changeShow less
    • Secondary endpoints revised (14)

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Enrollment target: 30 to 70 Primary completion date: Oct 2020 to Sep 2023 · Primary endpoint revised · Study sites: 1 to 4 · 3 morev3 Show 6 more changesShow less
    • Primary completion date: Oct 2020 to Sep 2023
    • Primary endpoint revised
    • Study sites: 1 to 4
    • Completion date: Oct 2023 to Sep 2025
    • Secondary endpoints: 13 to 14
    • Study description expanded, about 23 words

    See this version in full on ClinicalTrials.gov ↗

  2. Collaborators: 1 to 2v2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
In follow-up of the previous SynBioSe Study the present study is a randomized controlled trial designed to further investigate the long-term clinical and imunological efficacy of combination B-cell targeting by starting treatment with belimumab (anti-BAFF) followed by rituximab(anti-CD20) in lupus nephritis patients.
Trial Details
NCT Number NCT03747159
Lead Sponsor Leiden University Medical Center
Collaborators: Dutch Kidney Foundation, GlaxoSmithKline
Conditions Lupus Erythematosus, Systemic
Enrollment 71 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov