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: 22 Apr 2018

At a glance

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

    • 11 Apr 2018 According to a 4SC media release, company have enrolled 67 patients till date.
    • 11 Apr 2018 According to a 4SC media release, If the study results are positive, 4SC plans to submit applications for marketing approval of resminostat in CTCL in Europe and potentially the U.S. and Yakult Honsha will submit in Japan.
    • 11 Apr 2018 According to a 4SC media release, Yakult Honsha recruits first Japanese patient in pivotal RESMAIN study of resminostat in CTCL and Top-line results expected in the first half of 2019.
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