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

NCT04078386 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-01-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaofeng Zeng, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-21
Primary Completion
2021-06-23
Completion
2021-10-26

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04078386 on ClinicalTrials.gov