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

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT07299422
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-2173 Injection — DRUG
    SHR-2173 injection in different doses.
  • SHR-2173 Injection Placebo — DRUG
    SHR-2173 injection placebo.

Study Details

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.

Key Dates

First listed
Dec 23, 2025
Start date
Apr 3, 2026
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-2173 Injection Group
  • Placebo Comparator: SHR-2173 Injection Placebo Group

Primary Outcome Measure

The proportion of participants achieving Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 24. [ Time Frame: At Week 24. ]

Central Contacts

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