RECRUITING

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

Description

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
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Related Conditions:

Invasive Mold Infections

Study Overview

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Study Details

Study overview

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.

An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds

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

Condition
Invasive Mold Infections
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University School of Medicine, Infectious Diseases Clinical Research Unit, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.
  • 2. Patient's condition allows for appropriate infection source control measures.
  • 1. Refractory hematologic malignancy.
  • 2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • 3. COVID-19 associated mucormycosis.
  • 4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
  • 5. Patients with a Karnofsky Performance Status \< 20 at Screening.
  • 6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
  • 7. Patients with known human immunodeficiency virus infection.
  • 8. Ongoing neurological disorders.
  • 9. Patients receiving hospice/comfort care only.
  • 10. Other medical or psychiatric condition.
  • 11. Current use of any prohibited concomitant medication(s).
  • 12. Current/ previous administration of an investigational drug within 30 days.
  • 13. Prior enrollment in this or any previous study of fosmanogepix.
  • 14. Moderate or severe hepatic impairment.
  • 15. Patient who is pregnant or lactating.
  • 16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Basilea Pharmaceutica,

Daniel Ionescu, MD, STUDY_DIRECTOR, Basilea Pharmaceutica International Ltd, Allschwil

Study Record Dates

2028-02