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:
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 24 Apr 2024
Price :
$35
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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
- 01 Mar 2024 According to a 4SC media release, based on results from this trial the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for resminostat (Kinselby) for of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL).
- 27 Sep 2023 According to a 4SC media release, company received Orphan Drug Designation US Food and Drug Administration (FDA) for resminostat (Kinselby) in cutaneous T cell lymphoma.
- 25 Sep 2023 According to a 4SC media release, the company is on track to file for European Marketing Approval of Kinselby in Q1 2024.