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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05178862
Other study ID # SCY-078-302
Secondary ID MSG-20
Status Suspended
Phase Phase 3
First received
Last updated
Start date August 3, 2022
Est. completion date August 2024

Study information

Verified date November 2023
Source Scynexis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SCY-078
Oral ibrexafungerp (SCY-078) as step-down therapy.
Fluconazole
Oral fluconazole (SCY-078) as step-down therapy.
Echinocandin
Intravenous echinocandin

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Sponsors (1)

Lead Sponsor Collaborator
Scynexis, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Greece,  Israel,  Italy,  Korea, Republic of,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality (US FDA Only) The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population. Day 30
Primary Global Response at End of Treatment (EU European Medicines Agency [EMA] Only) The percentage of subjects with Successful Global Response, as determined by the Data Review Committee Up to 6 weeks
Secondary Global Response at Day 14 The percentage of subjects with Successful Global Response, as determined by the Data Review Committee Day 14
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