A Phase 2/3 Randomized Double-blind Placebo-controlled Multicenter Prospective Study to Assess the Efficacy Safety and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung Disease (MACrO2)
Brief description of study
Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR versus placebo + OBR in patients with treatment-refractory MAC lung disease. This study features a sequential Phase 2/3 approach with an initial Phase 2 assessment of symptom-based clinical responses, microbiological responses, safety, and PK associated with oral epetraborole, prior to the superiority analysis of oral epetraborole versus placebo in the Phase 3 part of the study. Results from the Phase 2 part of the study will inform of the specific PRO, the symptom-based clinical response definition, and the microbiological response criteria to be used in the Phase 3 part of the study. In addition, PK analyses from a Sentinel PK group in the Phase 2 part of the study will verify the dosage of oral epetraborole in patients with treatment-refractory MAC lung disease.
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