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Invasive Pulmonary AspergillosisPhase 2SCYNERGIANCT03672292

Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

A Phase 2 study testing SCY-078 and Voriconazole in people with Invasive Pulmonary Aspergillosis, run by Scynexis, Inc. at 8 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Invasive Pulmonary Aspergillosis
What is being tested?
SCY-078 and Voriconazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
8 sitesin 5 countries
Study dates
22 Jan 2019to 27 Mar 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is a male or female adult ≥18 years of age on the day the study informed consent form (ICF) is signed.
  • 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.
  • 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).
  • Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation OR
  • Subject 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
  • 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
Show all 9Show fewer
  • Subject with inherited severe immunodeficiency (e.g. chronic granulomatous disease, severe combined immunodeficiency)
  • 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.
  • 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).

Who cannot join

  • Subject has a fungal disease with central nervous system involvement suspected at Screening.
  • 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.
  • Subject has a Karnofsky score <20.
  • Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed.
  • Subject is under mechanical ventilation.
  • Subject has abnormal liver test parameters: AST or ALT >5 x ULN and/or total bilirubin >2.5 x ULN.

Trial locations and contacts

8 sites in 5 countries.

8 sites in 5 countries

United States3 sites

  • University of Michigan UH south F4005; 1500 E. Medical Center Drive SPC 5378

    Ann Arbor, Michigan, 48109

  • Brigham Womens Hospital INF 75 Francis Street PBB-A4

    Boston, Massachusetts, 02115

  • Wake Forest Baptist Medical Center 1 Medical Center Blvd.

    Winston-Salem, North Carolina, 27157

Other trials in United States

Belgium2 sites

  • Hematology Department AZ Sint-Jan Brugge - Oostende AV Campus Brugge Ruddershove 10 8000

    Bruges

  • UZ Leuven campus Gasthuisberg Hematology Department Herestraat 49 B - 3000

    Leuven

Other trials in Belgium

Canada1 site

  • University Health Network at the University of Toronto

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Germany1 site

  • Universitaetsklinikum Koeln, Klinisches Studienzentrum 2 für Infektiologie, Klinik I für Innere Medizin Kerpener Str. 62, Bettenhaus Ebene 15 Raum 64

    Cologne, 50937

Other trials in Germany

South Africa1 site

  • Alberts Cellular Therapy Center (ACT)

    Pretoria, Gauteng, 0044

Other trials in South Africa

About this study

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

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.

Read the detailed 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.

Being tested
SCY-078, Voriconazole, Oral Placebo Tablets
Keywords
Aspergillosis, SCY-078, Ibrexafungerp, Coadministration
Medical subject headings
Invasive Pulmonary Aspergillosis, Aspergillosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCY-078Drug

    Also called Ibrexafungerp

    Oral tablets of SCY-078

  • VoriconazoleDrug

    Voriconazole IV vials or oral tablets

  • Oral Placebo TabletsOther

    Also called SCY-078 matching Placebo

    Oral Placebo Tablets matching SCY-078

Study groups in NCT03672292
Study groupRoleWhat they receive
SCY-078 plus VoriconazoleExperimentalEither 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
Receives: Drug: SCY-078; Drug: Voriconazole
Voriconazole mono-therapyPlacebo comparatorEither 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
Receives: Drug: Voriconazole; Other: Oral Placebo Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to a maximum of 19 weeks

Secondary outcomes (8)

  1. 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.

    Measured: At end of treatment (up to 13 weeks), day 42 and day 84

  2. Percentage of Participants Who Died (Any Cause)

    Number and Percentage of participants who died (any cause)

    Measured: At Day 42 and Day 84

  3. 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).

    Measured: Weeks 1, 2, 4 and 6

  4. 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

    Measured: Weeks 1, 2, 4 and 6 from Baseline

  5. 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

    Measured: Up to a maximum of 19 weeks

  6. 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

    Measured: End of Treatment (EoT), Day 42 and Day 84

  7. 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

    Measured: End of Treatment (EoT), Day 42 and Day 84

  8. SCY-078 and Voriconazole Plasma Concentrations

    Voriconazole and SCY-078 plasma concentrations (ng/mL)

    Measured: Treatment Days 7 and 14 (2-4 hrs post dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start22 Jan 2019
  3. Primary completion27 Mar 2023
  4. Study completion27 Mar 2023

Why it stopped: Enrollment took longer than anticipated (slow enrollment during COVID).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672292
Sponsor's protocol ID
SCY-078-206
Other IDs
2018-002565-18, 2018
Acronym
SCYNERGIA
Status last verified
Aug 2024
First submitted
11 Sep 2018
Last updated
9 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCY-078 and Voriconazole in people with Invasive Pulmonary Aspergillosis, run by Scynexis, Inc. at 8 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Belgium, Canada, Germany, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03672292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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