Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.
This is a multicenter, randomized, double-blind, two-arm study to evaluate the safety, tolerability, efficacy and PK of the coadministration of SCY-078 plus voriconazole compared to those of voriconazole in male and female subjects 18 years of age and older with a probable or proven invasive pulmonary aspergillosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Oral tablets of SCY-078
Voriconazole IV vials or oral tablets
Oral Placebo Tablets matching SCY-078
Brigham Womens Hospital INF 75 Francis Street PBB-A4
Boston, Massachusetts, United States
University of Michigan UH south F4005; 1500 E. Medical Center Drive SPC 5378
Ann Arbor, Michigan, United States
Wake Forest Baptist Medical Center 1 Medical Center Blvd.
Winston-Salem, North Carolina, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths
Number of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs and deaths.
Time frame: Up to a maximum of 19 weeks
Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC)
Number and percentage of participants with Complete Response or Partial Response as determined by the Data Review Committee (DRC). Complete Response: Survival and resolution of all attributable symptoms and signs of disease; plus, successful radiological outcome; plus, mycological eradication. Partial Response: Survival and partial resolution of attributable symptoms and signs of disease; plus, improvement (at least 25%) of radiological lesions; plus, mycological eradication.
Time frame: At end of treatment (up to 13 weeks), day 42 and day 84
Percentage of Participants Who Died (Any Cause)
Number and Percentage of participants who died (any cause)
Time frame: At Day 42 and Day 84
Change in Serum Galactomannan Index (GMI)
Absolute change in serum GMI from from baseline to each time point (Weeks 1, 2, 4 and 6). Negative values indicate a reduction of GMI (i.e., improvement).
Time frame: Weeks 1, 2, 4 and 6
Percent of Participants With Changes in GMI
Percentage of participants with the following changes in GMI values from Baseline: * Fifty percent reduction or greater at Weeks 1, 2, 4 and 6 * Twenty-five percent reduction or greater at Weeks 1, 2, 4 and 6 * Any percent reduction at Weeks 1, 2, 4 and 6 * Reduction equal to or greater than 0.25 at Weeks 1, 2, 4 and 6 * Reduction to \< 0.5 at Weeks 1, 2, 4 and 6
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Hematology Department AZ Sint-Jan Brugge - Oostende AV Campus Brugge Ruddershove 10 8000
Bruges, Belgium
UZ Leuven campus Gasthuisberg Hematology Department Herestraat 49 B - 3000
Leuven, Belgium
University Health Network at the University of Toronto
Toronto, Ontario, Canada
Universitaetsklinikum Koeln, Klinisches Studienzentrum 2 für Infektiologie, Klinik I für Innere Medizin Kerpener Str. 62, Bettenhaus Ebene 15 Raum 64
Cologne, Germany
Alberts Cellular Therapy Center (ACT)
Pretoria, Gauteng, South Africa
Time frame: Weeks 1, 2, 4 and 6 from Baseline
Time to Achieve Serum GMI Change From Baseline
Time (days) to achieve the following changes in serum GMI from Baseline: * Fifty percent reduction * Twenty-five percent reduction * Any percent reduction * Reduction equal to or greater than 0.25
Time frame: Up to a maximum of 19 weeks
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the DRC * Mycological Response at EoT, Day 42 and Day 84, as determined by the DRC * Radiological Response at EoT, Day 42 and Day 84, as determined by the DRC
Time frame: End of Treatment (EoT), Day 42 and Day 84
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Mycological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Radiological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator
Time frame: End of Treatment (EoT), Day 42 and Day 84
SCY-078 and Voriconazole Plasma Concentrations
Voriconazole and SCY-078 plasma concentrations (ng/mL)
Time frame: Treatment Days 7 and 14 (2-4 hrs post dose)