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A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

Study acronym: EnVISage
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 80 to confirmed 83 · Study sites: 73 to 64v7 Show 2 more changesShow less
    • Enrollment target: estimated 80 to confirmed 83
    • Study sites: 73 to 64
  2. Study sites: 72 to 73v6
  3. Study sites: 70 to 72v5
  4. Site details revised at 12 of 70 sitesv4
  5. Study sites: 18 to 70v3
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 15, 2025 to Apr 23, 2025 · Site details revised at 18 of 18 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 15, 2025 to Apr 23, 2025
    • Site details revised at 18 of 18 sites
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.
Trial Details
NCT Number NCT06928142
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Sjogren Disease
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov