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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

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

Gomez Juan Carlos

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

Oct. 01, 2023

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

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.

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.

Both

Invasive fungal disease (IFD) caused by Aspergillus species

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.

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

+81-3-3588-1111

Oct. 16, 2023

No

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