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Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment

NCT03059992 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2024-11-20

Study results available
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Summary

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.

Conditions

  • Invasive Candidiasis
  • Mucocutaneous Candidiasis
  • Coccidioidomycosis
  • Histoplasmosis
  • Blastomycosis
  • Chronic Pulmonary Aspergillosis
  • Allergic Bronchopulmonary Aspergillosis
  • Invasive Pulmonary Aspergillosis
  • Recurrent Vulvovaginal Candidiasis
  • Other Emerging Fungi

Interventions

DRUG

Ibrexafungerp

Experimental Study Drug

Sponsors & Collaborators

  • Scynexis, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2023-08-25
Completion
2023-08-25
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Germany
  • Netherlands
  • Pakistan
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03059992 on ClinicalTrials.gov