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

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 651 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Acquired from Horizon in 2024.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	Dazodalibep	IV infusion
DRUG	Placebo	IV infusion

Timeline

• Start date: 2024-01-24
• Primary completion: 2026-08-19
• Completion: 2026-08-19
• First posted: 2023-10-27
• Last updated: 2026-01-16

Locations

216 sites across 26 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, Portugal, Puerto Rico, Serbia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study