A trial to evaluate the Safety and Efficacy of SCY-078 when co-administrated with Voriconazole to treat Patients with Invasive Aspergillosis.

Phase 1

• Conditions: Patients with Invasive Pulmonary Aspergillosis; MedDRA version: 20.0Level: LLTClassification code 10059259Term: Pulmonary aspergillosisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-002565-18-DE
• Lead Sponsor: SCYNEXIS, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-03
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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 possible, 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 one of the following:
a. a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation, OR
b. who either recently resolved or ongoing neutropenia (neutropenia defined as absolute neutrophil count < 0.5 x 109/L [< 500/mm3] for > 10 days), temporally related to the onset of fungal disease OR
c. 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
d. with inherited severe immunodeficiency (e.g. chronic granulomatous
disease, severe combined immunodeficiency).
5. Subject has not received more than 4 days (96 hours) of prior mold-active antifungal 12 NOV 2018 CONFIDENTIAL Page 22
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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 >10 x ULN and/or total bilirubin >5 x ULN.
7. Note: Subjects with unconjugated hyperbilirubinemia (< 7mg/dL) with a diagnosis of Gilbert’s disease are not excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified