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A Phase 3 single, two-part, randomized withdrawal pivotal study of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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Trial Profile

A Phase 3 single, two-part, randomized withdrawal pivotal study of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2024

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At a glance

  • Drugs DNTH 103 (Primary)
  • Indications Chronic inflammatory demyelinating polyradiculoneuropathy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Dianthus Therapeutics

    • Most Recent Events

    • 13 Nov 2024 New trial record
    • 07 Nov 2024 According to a Dianthus Therapeutics media release, initiation of a single, two-part, pivotal Phase 3 trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) anticipated by year-end (YE24). The Company believes this single pivotal trial will support BLA filing in adult patients with CIDP. Additional details regarding Phase 3 trial design and timelines will be provided by YE24.

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