Clinical Trials List
Protocol NumberC4791012
NCT Number(ClinicalTrials.gov Identfier)NCT05421858
2022-10-01 - 2026-01-16
Phase III
Recruiting2
An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis
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Sponsor
Basilea Pharmaceutica
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/08
Investigators and Locations
Co-Principal Investigator
- 曾建豪 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Po-Liang Lu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Adult patients with candidemia and/or invasive candidiasis
Objectives
To evaluate the efficacy and safety of fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis.
Test Drug
Fosmanogepix
CANCIDAS
Fosmanogepix
Caspofungin
Fluconazole
CANCIDAS
Fosmanogepix
Caspofungin
Fluconazole
Active Ingredient
Fosmanogepix
Caspofungin
Fosmanogepix
Caspofungin
Fluconazole
Caspofungin
Fosmanogepix
Caspofungin
Fluconazole
Dosage Form
Solution for Infusion
Lyophilized For Solution
Tablet
Lyophilized For Solution
Capsule
Lyophilized For Solution
Tablet
Lyophilized For Solution
Capsule
Dosage
20 mg/mL
20 mg/mL
400 mg
20 mg/mL
200 mg
20 mg/mL
400 mg
20 mg/mL
200 mg
Endpoints
The regulatory authorities in the United States and Europe/Japan have different primary efficacy outcome standards. The two primary efficacy endpoints are as follows:
• **U.S. Food and Drug Administration (US FDA) Primary Endpoint:**
Proportion of participants alive at Day 30 (secondary endpoint for the European Medicines Agency [EMA] and the Pharmaceuticals and Medical Devices Agency [PMDA], Japan).
• **EMA/Japan PMDA Primary Endpoint:**
Proportion of participants with an overall treatment success response at End of Study Treatment (EOST), as determined by an independent Adjudication Committee (AC) (secondary endpoint for the FDA).
• **U.S. Food and Drug Administration (US FDA) Primary Endpoint:**
Proportion of participants alive at Day 30 (secondary endpoint for the European Medicines Agency [EMA] and the Pharmaceuticals and Medical Devices Agency [PMDA], Japan).
• **EMA/Japan PMDA Primary Endpoint:**
Proportion of participants with an overall treatment success response at End of Study Treatment (EOST), as determined by an independent Adjudication Committee (AC) (secondary endpoint for the FDA).
Inclution Criteria
Inclusion Criteria:
Patients ≥ 18 years (or the minimum country-specific age of consent if > 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.
Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.
Patients ≥ 18 years (or the minimum country-specific age of consent if > 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.
Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.
Exclusion Criteria
Exclusion Criteria:
Existing infection
Infection known to be due to Candida krusei, in blood or any other normally sterile site.
Inappropriate fungal infection source control.
Diagnosis of certain deep-seated Candida infections.
Life expectancy of < 72 hours in the opinion of the investigator.
Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary).
Patients with known human immunodeficiency virus infection, who have CD4+ count < 200/mm3 or viral load > 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening.
Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.
Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.
Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., > 2 doses of a once daily antifungal agent or > 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).
Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).
Prior participation in this or any previous study of fosmanogepix.
Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin > 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.
Female patient is pregnant or lactating.
Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.
Existing infection
Infection known to be due to Candida krusei, in blood or any other normally sterile site.
Inappropriate fungal infection source control.
Diagnosis of certain deep-seated Candida infections.
Life expectancy of < 72 hours in the opinion of the investigator.
Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary).
Patients with known human immunodeficiency virus infection, who have CD4+ count < 200/mm3 or viral load > 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening.
Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.
Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.
Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., > 2 doses of a once daily antifungal agent or > 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).
Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).
Prior participation in this or any previous study of fosmanogepix.
Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin > 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.
Female patient is pregnant or lactating.
Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
450 participants
