SCY-078-206 (SCYNERGIA)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Combination Therapy of SCY-078 with Voriconazole in Patients with Invasive Pulmonary Aspergillosis (SCYNERGIA)

Study treatments

• arm 1: SCY-078 plus Voriconazole 
• arm 2: Voriconazole mono-therapy 

Inclusion criteria

• Age > 18 years
• Subject has a possible, probable or proven IPA based on EORTC-MSG criteria. 
• Subject has a result of a serum GMI ≥0.5 from a sample obtained within the 96 hours preceding enrollment into the study (Baseline/Treatment Day 1).
• Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation.
• Subject has not received more than 4 days (96 hours) of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study (Baseline/Treatment Day 1). 
• Subject has an IPA episode that, in the investigator´s judgement, requires antifungal therapy and may be adequately treated with voriconazole.

Exclusion criteria

• Subject has a fungal disease with central nervous system involvement suspected at Screening.
• Subject is receiving, has received or anticipates to be receiving concomitant medications that are listed in the prohibited medication list (Appendix A in full protocol) within the specified washout periods.
• Subject has a Karnofsky score <20.
•  Subject is under mechanical ventilation.
• Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5 x ULN.

Participating sites

• University Hospital Leuven Gasthuisberg