drugset / Trial / NCT06104124

A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

NCT06104124

Phase 3 Active not recruiting 651 enrolled Amgen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Timeline

Start
2024-01-24
Primary completion
2026-08-19
Completion
2026-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Dazodalibep Protein / enzyme biologic Intravenous

Indications