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Ibrexafungerp

Ibrexafungerp is being studied in clinical trials for invasive candidiasis and candidemia. These trials look at whether it is as effective as standard treatment after initial intravenous therapy, and they include adults with serious Candida infections. The main goals are to measure survival, treatment response, and overall safety and effectiveness.

Table of contents

Overview of the trial program

The clinical trial data provided for Ibrexafungerp focus on invasive candidiasis and candidemia, which are serious Candida infections.[1] The main study is designed to test whether a treatment plan that includes oral Ibrexafungerp after initial intravenous therapy can work as well as the standard oral option used in the comparison group.[1] The study is interventional, which means researchers assign the treatment plan rather than just observing usual care.[1]

Study design and treatment groups

The main trial, NCT05178862, is a Phase 3 study.[1] It compares two treatment regimens: intravenous echinocandin followed by oral Ibrexafungerp, versus intravenous echinocandin followed by oral fluconazole.[1] The trial summary says the goal is to show non-inferiority, meaning the Ibrexafungerp strategy should not perform worse than the comparison strategy by more than an allowed margin.[1]

The source data also lists several medicines used in the study setting, including micafungin, anidulafungin, caspofungin, voriconazole, and placebo versions used for masking in the trial process.[1] The provided data do not describe the full randomization or masking plan, but they do show that the study includes a structured comparison between treatment strategies.[1]

Who can participate

The available trial information says the study population includes people with invasive candidiasis and/or candidemia.[1] The data do not list all inclusion and exclusion rules, so the exact participation criteria cannot be fully described from the source provided.[1] Based on the trial title and condition, the study is aimed at patients who already need treatment for a serious Candida infection.[1]

What the trials measure

The main outcome is all-cause mortality at Day 30 in the intent-to-treat population.[1] In simple terms, this checks how many participants are alive 30 days after the study treatment period begins or after the planned study time point used by the trial.[1] The study also measures the percentage of participants with successful global response at end of treatment, as determined by the DRC in the EU-only analysis.[1]

The term DRC is used in the source data for the response assessment.[1] The data do not explain the full meaning of DRC, but they show that it is the group used to judge whether treatment success was achieved at the end of treatment.[1]

Trial status and size

The study NCT05178862 is listed as Completed.[1] It enrolled 240 participants.[1] The trial type is interventional, and the phase is Phase 3, which places it in a late stage of clinical research.[1]

Key patient-friendly terms

  • Candidemia means Candida is found in the blood, which can be very serious.[1]
  • Invasive candidiasis means the infection has spread deeper into the body, not just on the surface.[1]
  • Intravenous means medicine is given through a vein, usually in a hospital setting.[1]
  • Oral means medicine is taken by mouth as a tablet or capsule.[1]
  • Phase 3 means a larger study that helps show how well a treatment works compared with another option.[1]
  • Non-inferior means the new treatment is expected to be at least nearly as effective as the comparison treatment.[1]
Trial ID Phase Condition studied Status Enrollment
NCT05178862 Phase 3 Invasive Candidiasis / Candidemia Completed 240

FAQ

  • What are the Ibrexafungerp clinical trials studying? They are studying Ibrexafungerp as a treatment step after initial intravenous therapy for invasive candidiasis and candidemia. The main question is whether it works as well as standard oral treatment.
  • Who can take part in these trials? The trial data describe adults with invasive candidiasis and/or candidemia. Participation depends on the study rules, which are not fully listed in the source data.
  • What phase is the main trial? The main trial is Phase 3. This means it is a late-stage study that tests how well the treatment works in a larger group of patients.
  • What outcomes are being measured? The main outcomes are all-cause mortality at Day 30 and successful global response at end of treatment. In simple words, the study checks survival and whether the infection improves enough to count as a success.
  • What treatment comparison is being made? The study compares intravenous echinocandin followed by oral Ibrexafungerp with intravenous echinocandin followed by oral fluconazole. The goal is to show that Ibrexafungerp is not worse than the standard option.

Sperimentazioni cliniche in corso su Ibrexafungerp

  • Studio sui Trattamenti per Candidemia e Candidiasi Invasiva: Echinocandina Intravenosa seguita da Ibrexafungerp o Fluconazolo Orale per Pazienti con Candidemia o Candidiasi Invasiva

    Arruolamento concluso

    1 1 1
    Farmaci in studio:
    Belgio Bulgaria Francia Germania Grecia Italia +1

Glossario

  • Invasive candidiasis: A serious Candida infection that spreads beyond the usual surface areas and can affect the blood or internal organs.
  • Candidemia: Candida infection in the blood. It is a medical emergency because the infection can spread quickly.
  • Intravenous (IV) treatment: Medicine given through a vein, usually in a hospital or clinic.
  • Oral treatment: Medicine taken by mouth, such as a tablet or capsule.
  • Echinocandin: A group of antifungal medicines used first in the trial before switching to oral treatment.
  • Phase 3: A late stage of research where a treatment is tested in a larger number of people to see how well it works.
  • Non-inferior: A study goal meaning the new treatment should work at least almost as well as the comparison treatment.
  • All-cause mortality: Death from any cause during the study period.
  • Successful global response: A combined measure showing whether the infection has improved enough to be counted as a treatment success.
  • End of treatment (EOT): The point when the planned treatment period is finished.
  • Intent-to-treat (ITT) population: All participants included in the main analysis, usually based on the group they were assigned to.
  • Best Available Therapy (BAT): The best standard treatment available for the condition in that study setting.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sui-trattamenti-per-candidemia-e-candidiasi-invasiva-echinocandina-intravenosa-seguita-da-ibrexafungerp-o-fluconazolo-orale-per-pazienti-con-candidemia-o-candidiasi-invasiva/