A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

Phase 3

Recruiting

• Conditions: Candidiasis, Invasive; Candidemia
• Interventions: Drug: SCY-078; Drug: Fluconazole; Drug: Echinocandin

• Registration Number: NCT05178862
• Lead Sponsor: Scynexis, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Study Start: 2022-08-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-19
• Primary Completion: 2026-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
• Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).

Key

Exclusion Criteria

• Subject has any of the following forms of invasive candidiasis at Screening:

  • Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
  • Osteomyelitis,
  • Endocarditis or myocarditis,
  • Meningitis, endophthalmitis, or any central nervous system infection,
  • Chronic disseminated candidiasis,
  • Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
  • Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
  • Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
  • Patients who failed a previous antifungal therapy for the same infection,
  • Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.

• Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).

• Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).

• Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.

  o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.

• Baseline QTcF ≥ 500 msec.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV echinocandin followed by oral ibrexafungerp (SCY-078)	SCY-078	-
IV echinocandin followed by oral ibrexafungerp (SCY-078)	Echinocandin	-
IV echinocandin followed by oral fluconazole	Fluconazole	-
IV echinocandin followed by oral fluconazole	Echinocandin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Global Response at Day 14	Day 14	The percentage of subjects with Successful Global Response, as determined by the Data Review Committee

Trial Locations

Locations (73)

University of Alabama at Birmingham School of Medicine; 🇺🇸 Birmingham, Alabama, United States

Banner University Medical Center-Tucson; 🇺🇸 Tucson, Arizona, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Denver, Colorado, United States

Augusta University Medical Center; 🇺🇸 Augusta, Georgia, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

LSU Health Sciences Center; 🇺🇸 Shreveport, Louisiana, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

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