A multicentre, double blind, randomised, placebo controlled, Phase II trial to evaluate Resminostat for maintenance treatment of patients with advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sezary Syndrome (SS) that have achieved disease control with systemic therapy – the RESMAIN Study

Trial Profile

A multicentre, double blind, randomised, placebo controlled, Phase II trial to evaluate Resminostat for maintenance treatment of patients with advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sezary Syndrome (SS) that have achieved disease control with systemic therapy – the RESMAIN Study

Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2017

At a glance

  • Drugs Resminostat (Primary)
  • Indications Mycosis fungoides; Sezary syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms RESMAIN
  • Sponsors 4SC
  • Most Recent Events

    • 05 Dec 2017 According to a 4SC media release, one third of the patients have been enrolled in this trial according to plan by the end of November. Top-line results are expected in the first half of 2019. If the top-line results from this trial are positive, the company plans to submit resminostat for market approval in Europe and the US.
    • 31 Aug 2017 According to a 4SC media release, data from this study will be presented at the EORTC CLTF Meeting, Cutaneous Lymphomas: Insights & Therapeutic Progress 2017 Meeting.
    • 03 May 2017 According to a 4SC media release, this study was presented at the 13th Congress of the European Association of Dermato-Oncology.
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