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A Randomized, Double Blind, Placebo-controlled, Dose Escalation Phase 1b/2a Study to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

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A Randomized, Double Blind, Placebo-controlled, Dose Escalation Phase 1b/2a Study to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2024

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At a glance

  • Drugs CM 326 (Primary)
  • Indications Nasal polyps; Rhinosinusitis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms DUBHE
  • Sponsors KeyMed Biosciences

    • Most Recent Events

    • 08 Nov 2024 Status changed from active, no longer recruiting to completed.
    • 02 Aug 2023 Planned primary completion date changed from 30 Aug 2024 to 29 Aug 2023.
    • 27 Jul 2023 Number of treatment arms have been increased from 4 to 5 by the addition of Experimental: Group 4: 220mg Q4W arm. One more primary end-point added as"Changes from baseline of nasal polyp score", thus making TU also a trial focus. Timeline for the primary end-point "Incidence of AEs" increased from 24 weeks to 64 weeks.

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