Clinical Trial

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

Study acronym: EnVISage
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-04-07; most recent amendment 2026-03-16.
Status change: Recruiting → Active, Not Recruiting 2026-03-16
Status change: Not Yet Recruiting → Recruiting 2025-07-07
Trial Details
NCT Number NCT06928142
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Sjogren Disease
Enrollment 83 participants
Start Date 2025-04-23
Primary Completion 2027-03-13 (estimated)
Study Completion 2027-06-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-18