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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03672292




Registration number
NCT03672292
Ethics application status
Date submitted
11/09/2018
Date registered
14/09/2018

Titles & IDs
Public title
Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
Scientific 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
Secondary ID [1] 0 0
2018-002565-18
Secondary ID [2] 0 0
SCY-078-206
Universal Trial Number (UTN)
Trial acronym
SCYNERGIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Pulmonary Aspergillosis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SCY-078
Treatment: Drugs - Voriconazole
Other interventions - Oral Placebo Tablets

Experimental: SCY-078 plus Voriconazole - Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).

PLUS Oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks

Placebo comparator: Voriconazole mono-therapy - Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).

PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given QD from Day 3 onwards).

Treatment duration = minimum 6 weeks/Max 13 weeks


Treatment: Drugs: SCY-078
Oral tablets of SCY-078

Treatment: Drugs: Voriconazole
Voriconazole IV vials or oral tablets

Other interventions: Oral Placebo Tablets
Oral Placebo Tablets matching SCY-078
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths
Timepoint [1] 0 0
Up to a maximum of 19 weeks
Secondary outcome [1] 0 0
Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC)
Timepoint [1] 0 0
At end of treatment (up to 13 weeks), day 42 and day 84
Secondary outcome [2] 0 0
Percentage of Participants Who Died (Any Cause)
Timepoint [2] 0 0
At Day 42 and Day 84
Secondary outcome [3] 0 0
Change in Serum Galactomannan Index (GMI)
Timepoint [3] 0 0
Weeks 1, 2, 4 and 6
Secondary outcome [4] 0 0
Percent of Participants With Changes in GMI
Timepoint [4] 0 0
Weeks 1, 2, 4 and 6 from Baseline
Secondary outcome [5] 0 0
Time to Achieve Serum GMI Change From Baseline
Timepoint [5] 0 0
Up to a maximum of 19 weeks
Secondary outcome [6] 0 0
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Timepoint [6] 0 0
End of Treatment (EoT), Day 42 and Day 84
Secondary outcome [7] 0 0
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Timepoint [7] 0 0
End of Treatment (EoT), Day 42 and Day 84
Secondary outcome [8] 0 0
SCY-078 and Voriconazole Plasma Concentrations
Timepoint [8] 0 0
Treatment Days 7 and 14 (2-4 hrs post dose)

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/03/2023
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
Belgium
State/province [4] 0 0
Brugge
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Germany
State/province [7] 0 0
Köln
Country [8] 0 0
South Africa
State/province [8] 0 0
Gauteng

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Scynexis, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Angulo, MD
Address 0 0
Scynexis, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03672292