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Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis

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Trial Profile

Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Fipaxalparant (Primary)
  • Indications Diffuse scleroderma
  • Focus Adverse reactions
  • Sponsors Sanofi

    • Most Recent Events

    • 06 May 2018 Results published in the Arthritis and Rheumatology.
    • 17 Jun 2017 Results assessing the identification of a transcriptomic signature correlated with modified rodnan skin score (Mrss), presented at the 18th Annual Congress of the European League Against Rheumatism
    • 24 Mar 2016 Extension part is now incorporated in this study thus changes in official title, purpose, design, treatment as per ClinicalTrials.gov record.

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