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NCT05101187 · ClinicalTrials.gov registry record · Phase 3
Olorofim Aspergillus Infection Study
A Phase 3 study of Invasive Aspergillosis, sponsored by F2G Biotech.
- Active
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT05101187: Active Phase 3 study of Invasive Aspergillosis, sponsored by F2G Biotech.
NCT05101187 is a Phase 3 study of Invasive Aspergillosis that is active but no longer recruiting, run by F2G Biotech. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101187, a Phase 3 study of Invasive Aspergillosis, is active but no longer recruiting, sponsored by F2G Biotech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).
Primary Outcome
To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) Aspergillus species (invasive aspergillosis, IA).
Conditions Studied
Interventions
- DRUG Olorofim
- DRUG AmBisome®
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- University of California Davis Health System - Sacramento
- UCSF Helen Diller Medical Center at Parnassus Heights - San Francisco
Maryland
- The Johns Hopkins Hospital - Baltimore
- NIH Clinical Center ,NIAID,NIH - Bethesda
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester - Rochester
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke Department of Medicine Infectious Diseases Division - Durham
Alabama
- University of Alabama at Birmingham - Birmingham
Florida
- University of Florida - Gainesville
Georgia
- Augusta University - Augusta
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 3 |
What the registry record for NCT05101187 still lists
NCT05101187 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Invasive Aspergillosis appearing as the primary indexed condition, and to 2 interventions - of which Olorofim is the first listed.
NCT05101187 names 20 study sites across 15 states, led by California, Maryland, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05101187 about?
NCT05101187 is a clinical study titled "Olorofim Aspergillus Infection Study". The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).
What is the current status of trial NCT05101187?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2022-03-31. Estimated completion is 2026-11-01.
What conditions does trial NCT05101187 study?
This clinical trial studies the following conditions: Invasive Aspergillosis.
What interventions are being tested in trial NCT05101187?
The interventions under investigation include: Olorofim (DRUG), AmBisome® (DRUG).
Who is sponsoring clinical trial NCT05101187?
This trial is sponsored by F2G Biotech, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05101187 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Aspergillosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05101187's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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