A Phase III randomised study to evaluate the efficacy and safety of olorofim versus AmBisome (R) for treatment of invasive aspergillosis (IA) (OASIS)

A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome (R) followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230313

Enrollment

225

Registered

2023-08-29

Start date

2023-12-14

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive fungal disease (IFD) caused by Aspergillus species

Interventions

Olorofim: The dosing regimen will be a 1-day oral regimen of 150 mg olorofim twice daily, followed by a regimen of 90 mg olorofim twice daily from Day 2 onwards for up to 84 days. (The dosage can be a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Male and female patients ages>=18 years and weighing >= 30 kg 2.Patients with proven invasive aspergillosis (IA) at any site or probable lower respiratory tract disease Aspergillus species (LRTD IA). 3.Patients requiring therapy with an antifungal agent other than a mould-active azole. 4.AmBisome (R) is an appropriate therapy for the patient.

Exclusion criteria

Exclusion criteria: 1.Women who are pregnant or breastfeeding. 2.Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug (olorofim or AmBisome (R) ). 3.Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis. 4.Suspected mucormycosis (zygomycosis). 5.Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole. 6.The requirement for ongoing use of echinocandin as Candida prophylaxis. 7.Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features. 8.Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy. 9.Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) >= 500 msec, or at high risk for QT/QTc prolongation. 10.Evidence of hepatic dysfunction.

Design outcomes

Primary

Measure	Time frame
All cause mortality at Day 42 in the intent-to-treat (ITT) population	—

Countries

Australia, Belgium, Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, New Zealand, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Vietnam

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026