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To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment increased: 221 → 290 participants
    • Eligibility criteria expanded, about 9 words
    • Site details revised at 8 of 10 sites
    • Publications: details revised at 1 of 1 entry
  2. Phase: Phase 2 to Not applicablev3 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 30 to 221
    • Primary completion date: Jul 26, 2024 to Mar 24, 2028
    • Start date changed from estimate of Jul 16, 2023 to Dec 1, 2023
    • Study completion date: Oct 22, 2024 to Jun 29, 2028
    • Site details revised at 10 of 10 sites
  3. Phase: Phase 1 to Phase 2v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A multicenter, randomized Phase II/III clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.
Trial Details
NCT Number NCT05925452
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Active Systemic Juvenile Idiopathic Arthritis
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov