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COMPLETED
NCT04078386
PHASE2

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

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2019-11-21

Completion Date

2021-10-26

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

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.

Locations (14)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

The First Affiliated Hospital of USTC,Anhui Provincial Hospital

Hefei, Anhui, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Huzhou Third Municipal Hospital

Huzhou, Zhejiang, China

Beijing Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

West China School of Medicine,West China Hospital of Sichuan University

Chengdu, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Tianjin Medical University General Hospital

Tianjin, China

The First Affiliated Hospital of Xiamen University

Xiamen, China