drugset / Trial / NCT06245408

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

NCT06245408

Phase 3 Active not recruiting 434 enrolled Amgen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

Timeline

Start
2024-04-08
Primary completion
2026-10-22
Completion
2026-12-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Dazodalibep Protein / enzyme biologic Intravenous

Indications