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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 13 words Secondary endpoints: 13 to 14 Show 1 more changeShow less
    • Secondary endpoints: 13 to 14
  2. Recruitment opened Start date changed from estimate of Mar 2026 to Apr 3, 2026 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2026 to Apr 3, 2026
    • Site details revised at 2 of 2 sites
  3. Start date: Dec 2025 to Mar 2026 Enrollment target: 245 to 248 · Study sites: 1 to 2v3 Show 2 more changesShow less
    • Enrollment target: 245 to 248
    • Study sites: 1 to 2
  4. Interventions: SHR-1819 Injection Placebo (Drug), SHR-2173 Injection (Drug) to SHR-2173 Injection (Drug), SHR-2173 Injection Placebo (Drug)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07299422
Lead Sponsor Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions Systemic Lupus Erythematosus
Enrollment 248 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov