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A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Sickle Cell-Related Pain Crises

Trial Profile

A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Sickle Cell-Related Pain Crises

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Jul 2019

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At a glance

  • Drugs Crizanlizumab (Primary)
  • Indications Sickle cell anaemia
  • Focus Therapeutic Use
  • Acronyms SUSTAIN
  • Sponsors Reprixys Pharmaceuticals Corporation; Selexys Pharmaceuticals
  • Most Recent Events

    • 16 Jul 2019 According to a Novartis media release, the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) and has granted Priority Review for its investigational sickle cell medicine crizanlizumab (SEG101). If FDA-approved, crizanlizumab is expected to represent the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in sickle cell disease.The FDA submission is supported by this phase II study results.
    • 08 Jan 2019 Results presented in a Novartis Media Release.
    • 08 Jan 2019 According to a Novartis media release, Crizanlizumab is granted breakthrough therapy designation by the US FDA for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). The designation is granted based on positive results of this trial.
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