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

JRCT ID: jRCT2031230313

Registered date:29/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Invasive fungal disease (IFD) caused by Aspergillus species
• Date of first enrollment: 01/10/2023
• Target sample size: 225
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Egypt,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,New Zealand,Japan,Singapore,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,Vietnam,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

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 adjusted according to the manual.)
Treatment with AmBisome (R) followed by standard of care (SOC): After the initial course of at least 10 days of AmBisome (R) , subsequent therapy will be SOC therapy.

Outcome(s)

• Primary Outcome: All cause mortality at Day 42 in the intent-to-treat (ITT) population

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Gomez Juan Carlos
• Secondary ID(s): NCT05101187,2021-000386-32