MycosesPhase 2NCT02244606
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
A Phase 2 study testing SCY-078, Fluconazole and Micafungin in people with Mycoses and Candidiasis, Invasive, run by Scynexis, Inc. at 30 sites in 5 countries.
Trial summary
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mycoses, Candidiasis, Invasive, Candidemia
- What is being tested?
- SCY-078, Fluconazole and Micafungin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 30 sitesin 5 countries
- Study dates
- Sep 2014to Aug 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
- Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.
Who cannot join
- Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
- Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
- Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
- Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States24 sites
Albany Medical Center
Albany, New York, 12208
Georgia Regents University
Augusta, Georgia, 30912
University of Colorado Denver
Aurora, Colorado, 80045
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Mercury Street Medical Group
Butte, Montana, 59701
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Dallas VA Medical Center
Dallas, Texas, 75216
Parkland Hospital
Dallas, Texas, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Miami
Miami, Florida, 33125
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
UC Davis Medical Center
Sacramento, California, 95817
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84112
South Texas Veterans Healthcare System
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
El Salvador2 sites
Hospital Militar Central
San Salvador
Hospital Rosales
San Salvador
Honduras2 sites
Hospital Mario Catarino Rivas
San Pedro Sula, Cortés Department
Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula
San Pedro Sula, Cortés Department
About this study
Official title: Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.
Read the detailed description
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.
- Conditions
- Mycoses, Candidiasis, Invasive, Candidemia
- Being tested
- SCY-078, Fluconazole, Micafungin
- Keywords
- Invasive Candidiasis, Invasive Candida infections, Candidemia, SCY-078, Micafungin, Fluconazole, Echinocandin
- Medical subject headings
- Mycoses, Candidiasis, Invasive, Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCY-078Drug
FluconazoleDrug
MicafunginDrug
| Study group | Role | What they receive |
|---|---|---|
| SCY-078 500 mg | Experimental | A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. Receives: Drug: SCY-078 |
| SCY-078 750 mg | Experimental | A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. Receives: Drug: SCY-078 |
| Standard-of-care | Active comparator | Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily. Receives: Drug: Fluconazole; Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
All Related TEAEs by SOC and PT, by Treatment, Safety
Measured: up to 10 weeks
Dose of SCY-078 That Achieves the Target Exposure (AUC)
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
Measured: 0 to 24 hours post-dose
Secondary outcomes (4)
Global Response
Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)
Measured: end of all antifungal therapy (administered for a maximum of 28 days)
Clinical Response
Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy
Measured: end of all antifungal therapy (administered for a maximum of 28 days)
Microbiological Response
Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection
Measured: end of all antifungal therapy (administered for a maximum of 28 days)
Relapse
If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered
Measured: 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MycosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Angulo, MD, Study director, Scynexis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244606
- Sponsor's protocol ID
- SCY-078-202
- Status last verified
- May 2024
- First submitted
- 12 Sep 2014
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults
- ClinicalTrials.gov ID
- NCT02244606
- Acronym / sponsor ID
- SCY-078-202
- Conditions
- Mycoses, Candidiasis, Invasive, Candidemia
- Keywords
- Invasive Candidiasis, Invasive Candida infections, Candidemia, SCY-078, Micafungin, Fluconazole, Echinocandin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.
Detailed description
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCY-078 500 mg | Experimental | Drug: SCY-078A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. |
| SCY-078 750 mg | Experimental | Drug: SCY-078A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. |
| Standard-of-care | Active comparator | Drug: Fluconazole, Drug: MicafunginOral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
- Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.
Key exclusion criteria (4 listed)
- Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
- Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
- Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
- Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCY-078 | Drug | SCY-078 500 mg, SCY-078 750 mg |
| Fluconazole | Drug | Standard-of-care |
| Micafungin | Drug | Standard-of-care |
Primary outcome
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
Time frame: up to 10 weeks
All Related TEAEs by SOC and PT, by Treatment, Safety
Dose of SCY-078 That Achieves the Target Exposure (AUC)
Time frame: 0 to 24 hours post-dose
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
4 secondary outcomes
Global Response
Time frame: end of all antifungal therapy (administered for a maximum of 28 days)
Clinical Response
Time frame: end of all antifungal therapy (administered for a maximum of 28 days)
Microbiological Response
Time frame: end of all antifungal therapy (administered for a maximum of 28 days)
Relapse
Time frame: 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Angulo, MD study director
Scynexis, Inc.
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCY-078, Fluconazole and Micafungin in people with Mycoses and Candidiasis, Invasive, run by Scynexis, Inc. at 30 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, El Salvador, Honduras, Germany, Guatemala. 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. 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 25 Jun 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?
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements (time frame: up to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2024.