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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.

NCT06925321 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-05-20

No results posted yet for this 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

  • Invasive Mold Infections

Interventions

DRUG

Standard of care antifungal therapy

Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines

DRUG

Fosmanogepix oral tablet

Fosmanogepix will be administered orally.

DRUG

Fosmanogepix IV infusion

Fosmanogepix will be administered IV

Sponsors & Collaborators

Principal Investigators

  • Alison Kuchta, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Companies

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 NCT06925321 on ClinicalTrials.gov