SCY-078-031
Research type
Research Study
Full title
Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)
IRAS ID
237218
Contact name
Riina Richardson
Contact email
Sponsor organisation
SCYNEXIS, Inc.
Eudract number
2017-000381-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, days
Research summary
The aim of this phase III open label study is to evaluate SCY-078 efficacy by assessing Global Response at End of Treatment (EoT) as well as by measuring recurrence of the baseline fungal infection at 42 days after EoT, given in patients >18 years with a documented invasive and/or severe fungal disease that has been intolerant or refractory to standard of care antifungal treatment. SCY-078 safety and subject survival at 42 and 84 days after day 1 will be evaluated too.
The study will be conducted at approximately 40 sites worldwide, and is planned to enroll and treat approximately 60 subjects. Each subject is expected to complete the study, including all follow-up survival visits, within approximately 132 days from Baseline/Treatment Day 1.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0080
Date of REC Opinion
19 Apr 2018
REC opinion
Further Information Favourable Opinion