4SC-201-6-2015_Phase II trial to evaluate Resminostat

• Research type

  Research Study

• Full title

  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 Sézary Syndrome (SS) that have achieved disease control with systemic therapy – the RESMAIN Study

• IRAS ID

  210481

• Contact name

  Julia Scarisbrick

• Contact email

  juliascarisbrick@doctors.org.uk

• Sponsor organisation

  4SC AG

• Eudract number

  2016-000807-99

• Duration of Study in the UK

  3 years, 1 months, 16 days

• Research summary

  Research Summary:
  This is a phase II study to evaluate study drug called Resminostat. The study is to determine if drug will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy. Approximately 150 participants in about 10 European countries will take part in this study. Suitable participants will be randomised (chosen by chance) into two groups Resminostat-three film coated tablet 200mg each(600mg-3x200mg) or Placebo. The study is due to last for approximately 3 years. The Hospital visits will involve the following procedures: blood test, electrocardiogram(ECG) and several clinical examinations including skin biopsy and questionnaires. It is hoped the results of this study will help to develop better ways of treating patients with Mycosis fungoides or Sézary syndrome in the future.
  Lay summary of study results:
  https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-resminostat-for-t-cell-lymphoma-of-the-skin-resmain#undefined

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  16/LO/1469

• Date of REC Opinion

  15 Sep 2016

• REC opinion

  Further Information Favourable Opinion