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Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis

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

Record History

  1. Enrollment target: 236 to 423 Primary completion date: Jun 25, 2026 to Oct 2028 · Completion date: Aug 20, 2026 to Oct 2028 · Interventions: Placebo (Drug), SHR-1819 injection (Drug) to SHR-1819 Injection (Drug), SHR-1819 Injection Placebo (Drug) · 4 morev3 Show 7 more changesShow less
    • Primary completion date: Jun 25, 2026 to Oct 2028
    • Completion date: Aug 20, 2026 to Oct 2028
    • Interventions: Placebo (Drug), SHR-1819 injection (Drug) to SHR-1819 Injection (Drug), SHR-1819 Injection Placebo (Drug)
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (9)
    • Site contact updated
    • Study arms: 4 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 20, 2024 to Sep 19, 2024 · Secondary endpoints revised (9) · Site details revised · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Aug 20, 2024 to Sep 19, 2024
    • Secondary endpoints revised (9)
    • Site details revised
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
Trial Details
NCT Number NCT06554509
Lead Sponsor Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions Prurigo Nodularis
Enrollment 423 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov