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

Invasive Pulmonary Aspergillosis Clinical Trial

— SCYNERGIA  

Official title:

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Coadministration of SCY-078 With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672292
• Other study ID #: SCY-078-206
• Secondary ID: 2018-002565-18
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2019
• Est. completion date: March 27, 2023

Study information

• Verified date: February 2024
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 the protocol-specified criteria (Section 22.3) that requires antifungal treatment. Note: Subjects with possible IPA may enter the screening phase of the study but will only be randomized after meeting criteria for probable or proven IPA.

3. Subject has a result of a serum GMI 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 OR

5. Subject who either recently resolved or ongoing neutropenia (neutropenia defined as absolute neutrophil count < 0.5 x 10?/L [< 500/mm³] for > 10 days), temporally related to the onset of fungal disease OR

6. Subject who received treatment with other recognized T-cell immunosuppressants (such as cyclosporine, tacrolimus, monoclonal antibodies or nucleoside analogs) during the past 90 days including solid organ transplant patients OR

7. Subject with inherited severe immunodeficiency (e.g. chronic granulomatous disease, severe combined immunodeficiency)

8. 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.

9. 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:

1. 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 >5 x ULN and/or total bilirubin >2.5 x ULN.

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Intervention

Drug:
• SCY-078
Oral tablets of SCY-078
• Voriconazole
Voriconazole IV vials or oral tablets

Other:
• Oral Placebo Tablets
Oral Placebo Tablets matching SCY-078

Locations

Country	Name	City	State
Belgium	Hematology Department AZ Sint-Jan Brugge - Oostende AV Campus Brugge Ruddershove 10 8000	Brugge
Belgium	UZ Leuven campus Gasthuisberg Hematology Department Herestraat 49 B - 3000	Leuven
Canada	University Health Network at the University of Toronto	Toronto	Ontario
Germany	Universitaetsklinikum Koeln, Klinisches Studienzentrum 2 für Infektiologie, Klinik I für Innere Medizin Kerpener Str. 62, Bettenhaus Ebene 15 Raum 64	Köln
South Africa	Alberts Cellular Therapy Center (ACT)	Pretoria	Gauteng
United States	University of Michigan UH south F4005; 1500 E. Medical Center Drive SPC 5378	Ann Arbor	Michigan
United States	Brigham Womens Hospital INF 75 Francis Street PBB-A4	Boston	Massachusetts
United States	Wake Forest Baptist Medical Center 1 Medical Center Blvd.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events; discontinuation due to AE; death	Frequency of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs and deaths.	through study completion, an average of 19 weeks
Secondary	Composite clinical, radiological and mycological response (global response)	Percentage of subjects with Complete Response or Partial Response	At end of treatment, day 42 and day 84
Secondary	Death	Percentage of subjects who died (any cause)	At Day 42 and Day 84
Secondary	Change in serum GMI	Absolute and percent change in serum GMI from Baseline	Weeks 1, 2, 4 and 6
Secondary	Study drug and comparator plasma concentrations	SCY-078 and voriconazole plasma concentrations population PK analysis	Through the first 2 weeks of study