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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jan 2025

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At a glance

  • Drugs Resminostat (Primary)
  • Indications Cutaneous T-cell lymphoma; Mycosis fungoides; Sezary syndrome; Skin cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RESMAIN
  • Sponsors 4SC; 4SC AG

Most Recent Events

  • 07 Jan 2025 According to a 4SC media release, Subject to the EMA's decision, marketing authorisation approval is expected around mid-2025. This filing moves resminostat (Kinselby) another step closer to market following Orphan Drug Designation from the EMA in 2023 and from the Swiss Agency for Therapeutic Products (SwissMedic) in September 2024.
  • 30 Aug 2024 Status changed from active, no longer recruiting to completed.
  • 15 Aug 2024 This trial has been completed in Belgium (Global end date: 7 Aug 2024).

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