Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Detailed Description
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Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Official Title
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Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults

Conditions
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Mycoses, Candidiasis, Invasive, Candidemia

Intervention / Treatment
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* Drug: SCY-078
* Drug: Fluconazole
* Drug: Micafungin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida. Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception. Exclusion Criteria: Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis. Patient has failed treatment with an echinocandin for this episode of invasive candidiasis. Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture. Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCY-078 500 mg<br>A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. | Drug: SCY-078<br> <br> |
| Experimental: SCY-078 750 mg<br>A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. | Drug: SCY-078<br> <br> |
| Active Comparator: Standard-of-care<br>Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily. | Drug: Fluconazole<br> <br> Drug: Micafungin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements |  | from time of informed consent through 6-weeks after last study drug | 
| Dose of SCY-078 that achieves the target exposure (AUC) |  | during randomized study drug (administered for a maximum of 23 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global response |  | end of all antifungal therapy (administered for a maximum of 28 days) | 
| Clinical response |  | end of all antifungal therapy (administered for a maximum of 28 days) | 
| Microbiological response |  | end of all antifungal therapy (administered for a maximum of 28 days) | 
| Relapse |  | 2-weeks and 6-weeks after the end of all antifungal therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Candidiasis, Invasive Candida infections, Candidemia, SCY-078, Micafungin, Fluconazole, Echinocandin