Study to Evaluate the Safety and Efficacy of the Combination Therapy of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

  • Interventional
  • Recruiting
  • NCT03672292
Eligibility Details Visit Clinicaltrials.gov

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

Study to evaluate the safety and efficacy of combination therapy of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole mono-therapy 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 combination therapy of SCY-078 plus voriconazole compared to those of voriconazole monotherapy in male and female subjects 18 years of age and older with a hematological malignancy (HM) or a myelodysplastic syndrome or aplastic anemia or hematopoietic cell transplantation (HCT) and a probable or proven invasive pulmonary aspergillosis based on EORTCMSG criteria. In addition, all subjects must be positive (≥0.5) for serum GMI.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         1. Subject is a male or female adult ≥18 years of age on the day the study informed consent form (ICF) is signed.

         2. Subject has a probable or proven IPA based on EORTC-MSG criteria.

         3. 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).

         4. Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation.

         5. 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). However, subjects who have received more than 4 days but less than 7 days of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study may be enrolled but will require approval from the study medical monitor, who will evaluate each subject on a case-by-case basis.

         6. Subject has an IPA episode that, in the investigator´s judgement, requires antifungal therapy and may be adequately treated with voriconazole (i.e., the IPA is not a breakthrough infection while receiving a mold-active azole antifungal [voriconazole, posaconazole, isavuconazole or itraconazole] that requires therapy with a non-azole antifungal agent).

        Exclusion Criteria:

        Subject has a fungal disease with central nervous system involvement suspected at Screening. 2. 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. 3. Subject has a Karnofsky score <20. 4. Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed. 5. Subject is under mechanical ventilation. 6. Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5 x ULN.

At a Glance

National Government IDNCT03672292

IRB#IRB19-0171

Lead SponsorScynexis, Inc.

Lead PhysicianKathleen Mullane

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting