NCT03059992Phase 3Completed

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-08-25Actual

Enrollment · participants233Actual

Source updated2024-11-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

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

Treatments or interventions studied

IbrexafungerpDrugAlso known as SCY-078

Primary outcomes · main study measures

Read the study measures

measure: Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.; description: The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.; timeFrame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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