A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

Conditions

• Candidemia
• Candidiasis, Invasive

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fosmanogepix — DRUG
  IV infusion
• Fosmanogepix — DRUG
  Oral tablet
• Caspofungin — DRUG
  IV infusion
• Fluconazole — DRUG
  Fluconazole oral capsule
• Placebo — DRUG
  Matching placebo for caspofungin (IV infusion)
• Placebo — DRUG
  Matching placebo for fluconazole (oral capsule)
• Placebo — DRUG
  Matching placebo for fosmanogepix (IV infusion)
• Placebo — DRUG
  Matching placebo for fosmanogepix (oral tablet)

Study Details

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis. Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules. Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital. The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%. The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.

Key Dates

Start date

Dec 11, 2024

Status verified

May 2026

Primary completion

Jan 30, 2028

Completion

Jan 30, 2028

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fosmanogepix IV/oral
  Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to the oral form of fosmanogepix which is taken by mouth. Matching placebos for caspofungin and fluconazole will also be administered (a placebo does not have any medicine in it but looks just like the caspofungin and fluconazole).
• Active Comparator: Caspofungin IV/ Fluconazole oral
  Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to oral fluconazole which is taken by mouth. Matching placebos for fosmanogepix will also be administered (a placebo does not have any medicine in it but looks just like the medicine fosmanogepix being studied).

Primary Outcome Measure

Proportion of patients alive at Day 30 [ Time Frame: Day 30 ]

Central Contacts

• Manuel Häckl, MD
  +41 76 302 53 10
  [email protected]
• Marc Engelhardt, MD
  +41 79 701 0551
  [email protected]

Locations (23)

Find similar trials in Birmingham, AL

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