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A Proof of Concept, Phase II, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease (CUV040)

Trial Profile

A Proof of Concept, Phase II, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease (CUV040)

Planning
Phase of Trial: Phase II

Latest Information Update: 09 Oct 2018

At a glance

  • Drugs Afamelanotide (Primary)
  • Indications Variegate-porphyria
  • Focus Proof of concept; Therapeutic Use
  • Most Recent Events

    • 09 Oct 2018 New trial record
    • 01 Oct 2018 According to a Clinuvel Pharmaceuticals media release, the company has reached an agreement agreement with two European porphyria expert centres on a clinical trial protocol to conduct a Phase IIa proof of concept study evaluating the safety and effectiveness of SCENESSE (afamelanotide 16mg) in variegate porphyria (VP).
    • 01 Oct 2018 According to a Clinuvel Pharmaceuticals media release, the company will start patient treatment in the northern hemisphere spring of 2019. Commencement of the study is subject to regulatory and ethical approvals at both the national and local level of both expert centres involved.
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