A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus

NCT07299422 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2026-05-11

No results posted yet for this study

Summary

This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and a 12-week safety follow-up period. Approximately 245 SLE patients will be included.

Conditions

Interventions

DRUG

SHR-2173 Injection

SHR-2173 injection in different doses.

DRUG

SHR-2173 Injection Placebo

SHR-2173 injection placebo.

Sponsors & Collaborators

  • Guangdong Hengrui Pharmaceutical Co., Ltd

    lead INDUSTRY

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
2026-04-03
Primary Completion
2028-03-31
Completion
2028-11-30

Countries

  • China

Study Locations

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Entities

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 NCT07299422 on ClinicalTrials.gov