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

NCT05421858 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: FMGX-CS-3012022-500455-23-00
• Study Type: interventional
• Target: 450
• Locations: 19 countries
• Sites: 134

Brief Summary

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.

Conditions

Candidemia; Candidiasis, Invasive

Keywords

Fungal infection; Candida; Anti-fungal; Yeast

Outcome Measures

Primary Outcomes (2)

• Proportion of patients alive at Day 30

  Day 30

• Proportion of patients with an overall response of treatment success at end of study treatment (EOST)

  EOST (up to Day 42)

Secondary Outcomes (12)

• Proportion of patients with an overall response of treatment success at Day 7

  Day 7

• Proportion of patients with an overall response of treatment success at Day 14

  Day 14

• Proportion of patients with an overall response of treatment success at end of IV treatment (EOIV)

  up to Day 42

• Proportion of patients with an overall response of treatment success (sustained) at follow-up 6 weeks after EOST

  approximately up to 12,5 weeks

• Proportion of patients with clinical response of success at Day 7, 14, EOIV, EOST, Follow-up 6- weeks after EOST

  Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST]

Study Arms (2)

Fosmanogepix IV/oral

EXPERIMENTAL

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).

Drug: Fosmanogepix; Drug: Placebo

Caspofungin IV/ Fluconazole oral

ACTIVE COMPARATOR

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).

Drug: Caspofungin; Drug: Fluconazole; Drug: Placebo

Interventions

Fosmanogepix DRUG

IV infusion

Fosmanogepix IV/oral

Caspofungin DRUG

IV infusion

Caspofungin IV/ Fluconazole oral

Fluconazole DRUG

Fluconazole oral capsule

Caspofungin IV/ Fluconazole oral

Placebo DRUG

Matching placebo for caspofungin (IV infusion)

Fosmanogepix IV/oral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Basilea Pharmaceutica: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (138)

University of Alabama at Birmingham School of Medicine, Department of Medicine

Birmingham, Alabama, 35294-0006, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

RECRUITING

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Emory University Hospital - Clifton Road

Atlanta, Georgia, 30322, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912-5563, United States

RECRUITING

Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Kentucky College of Medicine

Lexington, Kentucky, 40506, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center

Ann Arbor, Michigan, 48109-5000, United States

RECRUITING

DMC Harper University Hospital

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases

Detroit, Michigan, 48202, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University School of Medicine, Infectious Diseases Clinical Research Unit

St Louis, Missouri, 63110, United States

RECRUITING

Weill Cornell Medical College - NewYork-Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104-6243, United States

RECRUITING

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213-2582, United States

RECRUITING

Houston Methodist Hospital - Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

U.T. MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24014, United States

RECRUITING

Central Hospital de San Isidro Melchor Posse

Buenos Aires, B1641, Argentina

RECRUITING

Buenos Aires Italian Hospital, Department of Infectious Diseases

Buenos Aires, C1199ABB, Argentina

RECRUITING

Cordoba Private University Hospital, Department of Infectious Diseases

Córdoba, X5016KEH, Argentina

RECRUITING

Italian Hospital of La Plata, Department of Infectious Diseases

La Plata, B1900, Argentina

RECRUITING

Central Hospital Mendoza

Mendoza, M5500IDN, Argentina

RECRUITING

British Sanatorium SA

Rosario, S2000CVB, Argentina

RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Peter MacCallum Cancer Center, State

Melbourne, Victoria, 3000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

Monash Medical Center Clayton

Clayton, 3168, Australia

RECRUITING

University Hospital Graz, Department of Internal Medicine

Graz, 1100, Austria

RECRUITING

Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases

Linz, 4021, Austria

RECRUITING

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine

Vienna, 1100, Austria

RECRUITING

General Hospital Saint-Jan

Bruges, 8000, Belgium

RECRUITING

University Hospital Brussels

Brussels, 1090, Belgium

RECRUITING

Saint Luc University Hospital, Department of Internal Medicine

Brussels, 1200, Belgium

RECRUITING

Erasme Hospital, Department of Infectious and Tropical Diseases

Brussels, B-1070, Belgium

RECRUITING

Jessa Hospital

Hasselt, 3500, Belgium

RECRUITING

University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases

Leuven, 3000, Belgium

RECRUITING

UCL Mont-Godinne University Hospitals

Yvoir, 5530, Belgium

SUSPENDED

HC-UFPR

Curitiba, Paraná, 80060-900, Brazil

RECRUITING

Hospital Our Lady of Grace

Curitiba, Paraná, 80810-040, Brazil

RECRUITING

Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Santa Marcelina Hospital

São Paulo, 08270-070, Brazil

RECRUITING

Eurohospital University Hospital

Plovdiv, 4004, Bulgaria

RECRUITING

University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic

Sofia, 1606, Bulgaria

RECRUITING

University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery

Sofia, 1606, Bulgaria

RECRUITING

China-Japan Friendship Hospital

Beijing, 100029, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, 233099, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510230, China

RECRUITING

Zhejiang Provincal Hospital of Chinese Medicine

Hangzhou, 310006, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, 310014, China

RECRUITING

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, 310016, China

RECRUITING

Lishui People's Hospital

Lishui, 323000, China

RECRUITING

Liuzhou People's Hospital

Liuchow, 530021, China

RECRUITING

The 1st Affiliated Hospital of Nanchang University

Nanchang, 330006, China

RECRUITING

Qingyuan People's Hospital

Qingyuan, 511518, China

RECRUITING

Huashan Hospital

Shanghai, 200040, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, 518112, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, 301617, China

RECRUITING

Wuxi People's Hospital

Wuxi, 214023, China

RECRUITING

Cardiomet CEQUIN Foundation, Department of Nephrology

Armenia, 630004, Colombia

RECRUITING

Luz Castro de Gutierrez Medellin General Hospital, Research Center

Medellín, 050015, Colombia

RECRUITING

Pablo Tobon Uribe Hospital

Medellín, 050034, Colombia

RECRUITING

High Technology Medical Institute S.A.S, IMAT S.A.S.

Montería, 230002, Colombia

RECRUITING

Somer Clinic

Rionegro, 54040, Colombia

RECRUITING

Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)

Amiens, 80054, France

RECRUITING

Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit

Argenteuil, 95107, France

RECRUITING

Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections

Marseille, 13015, France

SUSPENDED

Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases

Nantes, 44000, France

RECRUITING

Rennes University Hospital Center - Hospital Pontchaillou

Rennes, 35000, France

RECRUITING

Tours Regional University Hospital Center

Tours, 37000, France

RECRUITING

University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Frankfurt University Clinic

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

University Hospital Giessen and Marburg GmbH

Giessen, Hesse, 35392, Germany

RECRUITING

University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

University Hospital Heidelberg, Clinic for Anesthesiology

Heidelberg, 69120, Germany

RECRUITING

"LAIKO" General Hospital

Athens, 115 27, Greece

RECRUITING

"Sotiria" Chest Diseases Hospital of Athens

Athens, 11527, Greece

SUSPENDED

General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

Athens, PC 10676, Greece

RECRUITING

University General Hospital of Heraklion

Heraklion, 715 00, Greece

RECRUITING

Tzaneio General Hospital

Piraeus, 185 36, Greece

SUSPENDED

General Hospital of Thessaloniki "Ippokratio"

Thessaloniki, 54642, Greece

RECRUITING

Rambam Health Care Campus, Institute of Infectious Diseases

Haifa, 3109601, Israel

RECRUITING

Edith Wolfson Medical Center, Department of Infectious Diseases

Holon, 58100, Israel

RECRUITING

Chaim Sheba Medical Center, Department of Infectious Diseases

Ramat Gan, 52621, Israel

RECRUITING

The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit

Tel Aviv, 6423906, Israel

RECRUITING

Shamir Medical Center, Department of Infectious Diseases

Ẕerifin, 7033001, Israel

RECRUITING

Hospital "S. Croce e Carle"

Cuneo, 12100, Italy

RECRUITING

IRCCS Policlinic Hospital San Martino

Genoa, 16132, Italy

RECRUITING

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

Milan, 20122, Italy

RECRUITING

Hospital San Raffaele, IRCCS

Milan, 20132, Italy

RECRUITING

Big Metropolitan Hospital Niguarda Regional Health Authority

Milan, 20162, Italy

RECRUITING

University Polyclinic Hospital of Modena

Modena, 41124, Italy

RECRUITING

Polyclinic San Matteo, IRCCS

Pavia, 27100, Italy

RECRUITING

University Hospital of Pisa

Pisa, 56124, Italy

RECRUITING

AOU Senese

Siena, 53100, Italy

RECRUITING

Giuliano Isontina University Health Authority

Trieste, 34125, Italy

RECRUITING

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

SUSPENDED

Tan Tock Seng Hospital

Singapore, 308433, Singapore

SUSPENDED

Helen Joseph Hospital

Johannesburg, 2092, South Africa

RECRUITING

Milpark Hospital

Johannesburg, 2193, South Africa

SUSPENDED

Ryexo Clinical Research

Pretoria, 0084, South Africa

WITHDRAWN

University of Pretoria / Steve Biko Academic Hospital

Pretoria, 0084, South Africa

RECRUITING

Practice of R Moodley and MI Sarvan - Umhlanga

Umhlanga, 4320, South Africa

RECRUITING

Kyungpook National University Hospital

Daegu, 41944, South Korea

SUSPENDED

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

SUSPENDED

Ajou University Hospital

Suwon, 16499, South Korea

RECRUITING

University Hospital Virgen Macarena

Seville, Andalusia, 41009, Spain

RECRUITING

University Hospital Nuestra Senora de Valme

Seville, Andalusia, 41014, Spain

RECRUITING

Hospital del Mar, Department of Infectious Diseases

Barcelona, Catalonia, 08003, Spain

RECRUITING

University Hospital Vall d'Hebron, Intensive Care Unit (ICU)

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Clinic of Barcelona, Department of Infectious Diseases

Barcelona, Catalonia, 08036, Spain

SUSPENDED

University Hospital Ramon y Cajal, Department of Infectious Diseases

Madrid, Madrid, 28034, Spain

RECRUITING

University Hospital Cruces

Barakaldo, 48903, Spain

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807377, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

RECRUITING

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 404327, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 11000, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

Vajira Hospital

Bangkok, 10300, Thailand

RECRUITING

Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

RECRUITING

Songklanagarind Hospital

Hat Yai, 90110, Thailand

RECRUITING

Srinagarind Hospital

Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Candidemia; Candidiasis, Invasive; Mycoses; Torulopsis

Interventions

Caspofungin; Fluconazole

Condition Hierarchy (Ancestors)

Candidiasis; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Manuel Häckl, MD

  Basilea Pharmaceutica International Ltd, Allschwil

  STUDY DIRECTOR

Central Study Contacts

Manuel Häckl, MD

CONTACT

+41 76 302 53 10; manuel.haeckl@basilea.com

Marc Engelhardt, MD

CONTACT

+41 79 701 0551; marc.engelhardt@basilea.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 16, 2022
• Study Start: December 11, 2024
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (23); TH (5); BE (7); KR (4); DE (6); ZA (5); AU (6); CO (5); FR (6); AR (6); CN (14); SG (3); BR (5); TW (8); IT (10); GR (6); ES (7); BU (3); IL (5)