NCT06312020

A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren's Syndrome

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

Detailed description

The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo. Acquired from Horizon in 2024.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	HZN-1116	Subcutaneous Administration
DRUG	Placebo	Subcutaneous Administration

Timeline

• Start date: 2024-05-09
• Primary completion: 2026-03-19
• Completion: 2026-11-24
• First posted: 2024-03-15
• Last updated: 2025-10-24

Locations

65 sites across 16 countries: United States, Argentina, Austria, Chile, Colombia, France, Germany, Hungary, Italy, Mexico, Poland, Portugal, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study