NCT06484855

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Patients With Primary Sjogren's Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	IBI355	IBI355 IV. Q4W
DRUG	IBI355 placebo	IBI355 placebo IV. Q4W

Timeline

• Start date: 2024-07-14
• Primary completion: 2025-06-21
• Completion: 2025-07-25
• First posted: 2024-07-03
• Last updated: 2025-09-15

Locations

1 site across 1 country: China