Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

Phase 3

Completed

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

• Registration Number: NCT03363841
• Lead Sponsor: Scynexis, Inc.

Brief Summary

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.

Detailed Description

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days.

Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment.

Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)

Study Timeline

• Study First Submitted: 2017-11-14
• Study Start: 2017-11-15
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-06
• Primary Completion: 2023-04-14
• Study Completion: 2023-05-24
• Results First Submitted: 2024-05-10
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subject must fulfill the following KEY criteria to be eligible for study admission:

  1. Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed.
  2. Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days.
  3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.

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Exclusion Criteria

• KEY exclusion criteria:

  1. Subject has a fungal disease with central nervous system involvement.
  2. Subject has a fungal disease of the bone and/or joint that is expected to require >90 days of study drug treatment.
  3. Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
  4. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
  5. Subject has abnormal liver test parameters: AST or ALT >10 x ULN, and/or total bilirubin >5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded.
  6. Subject has an Apache score >16.
  7. Subject has serum creatinine >3 times from Baseline (Screening/Treatment Day 1) value.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCY-078	SCY-078	SCY-078

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee	At (EoT) Visit (up to 90 days after Day 1)	The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Recurrence of Baseline Fungal Infection	42 Days after the End of Treatment visit	The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up
Number of Participants Discontinued Due to Adverse Events	Through study completion (up to 132 Days)	Number of participants with Discontinuations due to Adverse Events
Percentage of Participants Surviving 42 and 84 Days	Day 42 and Day 84 after first dose of study drug	Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug)
Percent of Participants With Treatment-emergent Adverse Events	Through study completion, up to 132 days	Percent of participants with treatment-emergent Adverse Events (TEAEs)

Trial Locations

Locations (12)

Scynexis, Inc.; 🇺🇸 Jersey City, New Jersey, United States

Amrita Institute of Medical Sciences (AIMS); 🇮🇳 Kanayannur, Kochi, India

St John's Medical College and Hospital; 🇮🇳 Bangalore, Karnataka, India

King George Medical University; 🇮🇳 Lucknow, Uttar Pradesh, India

Institute of Critical Care Medicine Max Super Specialty Hospital; 🇮🇳 Saket, New Delhi, India

Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care; 🇮🇳 Chandigarh, India

Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157; 🇿🇦 Centurion, Gauteng, South Africa

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan

Into Research, Life Groenkloof Hospital; 🇿🇦 Pretoria, Gauteng, South Africa

Johese Clinical Research, Midstream; 🇿🇦 Pretoria, Gauteng, South Africa

Zuid Afrikaans Hospital; 🇿🇦 Pretoria, South Africa

Emmed Research, Jakarta Hospital; 🇿🇦 Pretoria, Gauteng, South Africa