NCT06245408

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

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 Symptom State (HZNP-DAZ-303)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Acquired from Horizon in 2024.

Conditions

• Sjögren's Syndrome (SS)

Interventions

Type	Name	Description
DRUG	Dazodalibep	IV infusion
DRUG	Placebo	IV infusion

Timeline

• Start date: 2024-04-08
• Primary completion: 2026-10-22
• Completion: 2026-12-17
• First posted: 2024-02-07
• Last updated: 2026-01-08

Locations

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

Regulatory

• FDA-regulated drug study