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A Study of Anti-IL-6R mAb Injection in Patients With iMCD

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv4 Show 8 more changesShow less
    • Enrollment target: estimated 9 to confirmed 25
    • Study completion date: Dec 2024 to Dec 31, 2025
    • Interventions: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg (Biological), Recombinant Humanized… to Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w (Biological), Recombinant Humanized…
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description expanded, about 272 words
    • Site details revised at 3 of 3 sites
    • Study arms: 3 to 5
    • Eligibility criteria shortened, about 5 words
  2. Primary completion date changed from estimate of Jan 2023 to Nov 27, 2022
    • Study completion date: Feb 2023 to Dec 2024
    v3
  3. Secondary endpoints revised (9)v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a single-arm, open-label, multicenter, dose-escalation clinical study. Its primary purpose is to evaluate the safety and tolerability of recombinant humanized anti-interleukin-6 receptor monoclonal antibody ( Anti-IL-6R mAb ) injection in patients with Idiopathic Multicentric Castleman's Disease ( iMCD ) and to determine the recommended dose for follow-up studies. Its secondary purpose is to evaluate the preliminary efficacy, immunogenicity and pharmacokinetic ( PK ) index, pharmacodynamic ( PD ) characteristics of Anti-IL-6R mAb injection in patients with iMCD.
Trial Details
NCT Number NCT05345522
Lead Sponsor Beijing VDJBio Co., LTD.
Conditions
(from sponsor)		 Idiopathic Multicentric Castleman's Disease
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov