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A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis

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Trial Profile

A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Feb 2024

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At a glance

  • Drugs FT 011 (Primary)
  • Indications Diffuse scleroderma
  • Focus Pharmacokinetics
  • Sponsors Certa Therapeutics
  • Most Recent Events

    • 19 Feb 2024 According to Certa Therapeutics media release, based on the results from this study, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for FT011 for the treatment of systemic sclerosis (scleroderma).
    • 30 Nov 2023 Status changed from active, no longer recruiting to completed.
    • 15 Nov 2023 Results assessing pharmacokinetics, pharmacodynamic effects, and safety, presented at the ACR Convergence 2023
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