NCT04078386

A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome

A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Patients received the test group Placebo weekly administered subcutaneously for 24 times.
BIOLOGICAL	RC18 240 mg	Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
BIOLOGICAL	RC18 160 mg	Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.

Timeline

• Start date: 2019-11-21
• Primary completion: 2021-06-23
• Completion: 2021-10-26
• First posted: 2019-09-06
• Last updated: 2022-01-11

Locations

1 site across 1 country: China