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A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 21, 2026 to Dec 2028 Enrollment target: 112 to 166 · Completion date: May 16, 2027 to Dec 2028 · Interventions: SHR-1703 (Drug), SHR-1703 Placebo (Drug) to Mepolizumab Injection (Drug), SHR-1703 (Drug) · 2 morev3 Show 5 more changesShow less
    • Enrollment target: 112 to 166
    • Completion date: May 16, 2027 to Dec 2028
    • Interventions: SHR-1703 (Drug), SHR-1703 Placebo (Drug) to Mepolizumab Injection (Drug), SHR-1703 (Drug)
    • Secondary endpoints revised (24)
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 15, 2023 to Nov 16, 2023 · Study sites: 0 to 2v2 Show 2 more changesShow less
    • Start date changed from estimate of Aug 15, 2023 to Nov 16, 2023
    • Study sites: 0 to 2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Trial Details
NCT Number NCT05979051
Lead Sponsor Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions Eosinophilic Granulomatosis With Polyangiitis
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov