Olorofim Aspergillus Infection Study

NCT05101187 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: F901318/0041
• Study Type: interventional
• Target: 225
• Locations: 20 countries
• Sites: 140

Brief Summary

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Conditions

Invasive Aspergillosis

Keywords

Invasive fungal disease (IFD); Aspergillus species; Olorofim; Non-azole antifungal; Azole resistance

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) Aspergillus species (invasive aspergillosis, IA).

  Treatment Day 42

Secondary Outcomes (9)

• Adjudicated Assessment of Overall outcome

  Day 42, Day 84, and End of Treatment (anytime during the study between first administration and Day 84)

• Investigator-assessed overall response

  Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]), and 4-week Follow-up (FU).

• To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Galactomannan index.

  Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) and 4-week Follow-up (FU)

• To collect additional olorofim and the disproportionate metabolite H26C pharmacokinetic (PK) data for inclusion in a Population PK model

  Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 70, Day 84, and at EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])

• Data Review Committee's Assessment of Patient Mortality

  Day 42 and 84 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])

Study Arms (2)

Olorofim

ACTIVE COMPARATOR

Olorofim versus AmBisome followed by Standard of Care (SOC)

Drug: Olorofim

AmBisome

ACTIVE COMPARATOR

Olorofim versus AmBisome followed by Standard of Care (SOC)

Drug: AmBisome®

Interventions

Olorofim DRUG

Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days)

Also known as: Olorofim (F901318)

Olorofim

AmBisome® DRUG

Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling.

Also known as: AmBisome® (liposomal amphotericin B)

AmBisome

Eligibility Criteria

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

You may qualify if:

• Male and female patients ages over 18 years and weighing more than 30 kg
• AmBisome® is an appropriate therapy for the patient.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
• Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
• Suspected mucormycosis (zygomycosis).
• Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
• The requirement for ongoing use of echinocandin as Candida prophylaxis.
• Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
• Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
• Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.
• Evidence of hepatic dysfunction.

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Iqvia Pty Ltd: collaborator
• Shionogi: collaborator

Study Sites (140)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California Davis Health System

Sacramento, California, 95817, United States

Location

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, 94143, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 64111, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

NIH Clinical Center ,NIAID,NIH

Bethesda, Maryland, 20892, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Clairvoyant Research Group, LLC

Las Vegas, Nevada, 89119, United States

Location

Rutgers RWJMS

New Brunswick, New Jersey, 08901, United States

Location

Weill Cornell Medicine NY Presbyterian Hospital

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Duke Department of Medicine Infectious Diseases Division

Durham, North Carolina, 27710, United States

Location

OU Health OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, 15232, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109-1024, United States

Location

Royal NorthShore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 3000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Hospital Felício Rocho

Belo Horizonte, Minas Gerais, 30110-934, Brazil

Location

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, 37904-020, Brazil

Location

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Paraná, 81520-060, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital de Clínicas de Porto Alegre

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

Location

Hospital São Lucas da PUCRS

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

Location

Hospital da Universidade Federal de Santa Maria CEP/UFSM

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Hamilton Health Sciences - Juravinski Site

Hamilton, Ontario, L8L 2X2, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G1M1, Canada

Location

University Health Network

Toronto, Ontario, M5G1N8, Canada

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Institute of Hematology and Blood Diseases Hospital

Xiaobailou, Tianjin Municipality, 300020, China

Location

The 1st Affiliated Hosp of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Peking University People's Hospital

Beijing, 100033, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

Xiangya Hospital, Central South University

Changsha, 410000, China

Location

Chenzhou No.1 People's Hospital

Chenzhou, 423000, China

Location

Fujian Medical University Union Hospital

Fuzhou, 350001, China

Location

Guangdong Provincial People's Hospital

Guangzhou, 510080, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510080, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, 510515, China

Location

The First Affiliated Hospital of Zhejiang University school of medicine

Hangzhou, 310003, China

Location

Anhui Provincial Hospital

Hefei, 230001, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, 530000, China

Location

Shengjing Hospital of China Medical University

Shengyang, 110055, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, 50004, China

Location

Xi'an International Medical Center

Xi'an, 710126, China

Location

Henan Provincial People's Hospital

Zhengzhou, 450003, China

Location

Institut de Cancérologie de Strasbourg Europe - ICANS

Strasbourg, Bas Rhin, 67200, France

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, Doubs, 25030, France

Location

CHU de Besancon

Besançon, Doubs, 25030, France

Location

CHU Bordeaux Hopital Saint André

Bordeaux, Gironde, 33000, France

Location

Institut Universitaire du Cancer de Toulouse- IUCT-O

Toulouse, Haute Garonne, 31059, France

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, 35000, France

Location

CHU de Nantes CIC Hematologie

Nantes, Loire Atlantique, 44093, France

Location

Hospital Claude Huriez

Lille, Nord, 59037, France

Location

Hôpital Necker - Enfants Malades

Paris, Paris, 75015, France

Location

Universitatsklinikum Leipzig

Leipzig, Saxony, 4103, Germany

Location

Charite Universitatsmedizin Berlin

Berlin, 12203, Germany

Location

Universitaetsklinikum Koeln

Cologne, 59037, Germany

Location

UKE Universitaetsklinikum-Hamburg Eppendorf

Hamburg-Eppendorf, 30625, Germany

Location

Soroka University Medical Center

Beersheba, 84001, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center Pt

Tel Aviv, 64239, Israel

Location

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Naples, Campania, 80138, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori

Monza, Di Monza E Della Brianza, 20900, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 2089, Italy

Location

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

AOU Policlinico di Modena

Modena, 41124, Italy

Location

Clinica Malattie Infettive Dipartimento di Medicina e Chirurgia dell'Università

Perugia, 6129, Italy

Location

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

Pisa, 56100, Italy

Location

Inmi Lazzaro Spallanzani Irccs

Roma, 149, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 168, Italy

Location

Chiba University Hospital

Chiba, Chiba, 260 8677, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812 8582, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980 8574, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541 8567, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Osaka, 545 8586, Japan

Location

Kindai University Hospital

Ōsaka-sayama, Osaka, 589 8511, Japan

Location

The Jikei University Hospital

Minato-Ku, Tokyo, 105-8471, Japan

Location

Toranomon Hospital

Minatoku, Tokyo to, 105 8470, Japan

Location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyō City, 1138677, Japan

Location

Nagasaki University Hospital

Nagasaki, 852 8501, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

Saitama Medical Center Jichi Medical University

Saitama, 3290431, Japan

Location

Jichi Medical University Hospital

Shimotsuke, 3290431, Japan

Location

Radboud Nijmegen

Nijmegen, 6525GA, Netherlands

Location

UMC Utrecht

Utrecht, 3508 GA, Netherlands

Location

Wellington Regional Hospital

Newtown, Wellington Region, 6021, New Zealand

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

National University Hospital

Singapore, 117599, Singapore

Location

Singapore General Hospital- Parent

Singapore, 169608, Singapore

Location

The Catholic University of Korea

Bucheon-si, Seoul, 06591, South Korea

Location

Samsung Medical Center

Irwon-dong, Seoul, 06351, South Korea

Location

Hospital General Universitario Gregorio Marañón

Retiro, Madrid, 28007, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, 23561, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Dicle University, Medical Faculty

Diyarbakır, 21280, Turkey (Türkiye)

Location

Acibadem Atakent Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Ondokuz Mayis Univ. Med. Fac.

Samsun, 55270, Turkey (Türkiye)

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Imperial College London

London, W6 8RP, United Kingdom

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

olorofim; liposomal amphotericin B

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Johan Maertens, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Adjudicator and sponsor-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: November 1, 2021
• Study Start: March 31, 2022
• Primary Completion: November 18, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

TW (5); CA (4); FR (9); GB (3); NZ (2); ES (7); TU (6); BE (4); AU (5); KR (2); IL (4); CN (23); IT (11); DE (4); NL (2); US (24); SG (2); TH (2); BR (8); JP (13)