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
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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