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NCT06925321 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
A Phase 3 study of Invasive Mold Infections, sponsored by Basilea Pharmaceutica.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
- 20
- Study locations
NCT06925321: Recruiting Phase 3 study of Invasive Mold Infections, sponsored by Basilea Pharmaceutica.
NCT06925321 is a Phase 3 study of Invasive Mold Infections that is actively recruiting participants, run by Basilea Pharmaceutica. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06925321, a Phase 3 study of Invasive Mold Infections, is actively recruiting participants, sponsored by Basilea Pharmaceutica.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. The patient will be assigned to one of two treatment cohorts: Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment. Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Conditions Studied
Interventions
- DRUG Fosmanogepix IV infusion
- DRUG Standard of care antifungal therapy
- DRUG Fosmanogepix oral tablet
Study Locations (20)
Other
- Peter MacCallum Cancer Center - Melbourne
- Princess Alexandra Hospital - Woolloongabba
- Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology - Linz
- Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine - Vienna
- University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology - Leuven
- Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases - Nantes
California
- David Geffen School of Medicine at UCLA - Los Angeles
- UC Davis Medical Center - Sacramento
Michigan
- University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center - Ann Arbor
- Karmanos Cancer Institute - Detroit - Detroit
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke University Medical Center, Duke Infectious Diseases - Durham
Alabama
- University of Alabama at Birmingham School of Medicine, Department of Medicine - Birmingham
Kentucky
- University of Kentucky Medical Center, Division of Infectious Diseases - Lexington
Maryland
- Johns Hopkins Hospital - Baltimore
Minnesota
- University of Minnesota, M Health Fairview Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2028-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06925321
The ClinicalTrials.gov registry entry for NCT06925321 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). The listed sponsor is Basilea Pharmaceutica, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Invasive Mold Infections appearing as the primary indexed condition, and to 3 interventions - of which Fosmanogepix IV infusion is the first listed.
NCT06925321 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT06925321 about?
NCT06925321 is a clinical study titled "A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.". The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be ap...
What is the current status of trial NCT06925321?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2025-08-26. Estimated completion is 2028-02.
What conditions does trial NCT06925321 study?
This clinical trial studies the following conditions: Invasive Mold Infections.
What interventions are being tested in trial NCT06925321?
The interventions under investigation include: Fosmanogepix IV infusion (DRUG), Standard of care antifungal therapy (DRUG), Fosmanogepix oral tablet (DRUG).
Who is sponsoring clinical trial NCT06925321?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06925321 being conducted?
This trial has 20 study locations across Alabama, California, Kentucky, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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How this trial's enrollment target compares
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