A Phase 3 interventional study of SCY-078 in Candidiasis, Invasive and Candidemia, sponsored by Scynexis, Inc.. Completed at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Scynexis, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days.
Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment.
Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)
73 studies on the registry are indexed under Candidemia; 5 are open to participants now.
This study's enrollment of 30 is below the median of 63 across 44 interventional studies indexed under Candidemia.
Browse Candidemia studies →Scynexis, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Compared within Candidemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Candidiasis, Invasive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must fulfill the following KEY criteria to be eligible for study admission:
Exclusion Criteria:
KEY exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SCY-078
Drug: SCY-078
Oral SCY-078
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.
Time frame: At (EoT) Visit (up to 90 days after Day 1)
Percent of Participants With Treatment-emergent Adverse Events
Percent of participants with treatment-emergent Adverse Events (TEAEs)
Time frame: Through study completion, up to 132 days
Number of Participants Discontinued Due to Adverse Events
Number of participants with Discontinuations due to Adverse Events
Time frame: Through study completion (up to 132 Days)
Percentage of Participants With Recurrence of Baseline Fungal Infection
The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up
Time frame: 42 Days after the End of Treatment visit
Percentage of Participants Surviving 42 and 84 Days
Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug)
Time frame: Day 42 and Day 84 after first dose of study drug
| Milestone | SCY-078 |
|---|---|
| Started | 30 |
| Completed | 20 |
| Not completed | 10 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Death | 7 |
| Withdrew: Physician decision | 1 |
The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.
| Participants | Ibrexafungerp 750mg |
|---|---|
| Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee | 21 |
Percent of participants with treatment-emergent Adverse Events (TEAEs)
| Participants | Ibrexafungerp 750 mg |
|---|---|
| Percent of Participants With Treatment-emergent Adverse Events | 25 |
Number of participants with Discontinuations due to Adverse Events
| Participants | Ibrexafungerp 750 mg |
|---|---|
| Number of Participants Discontinued Due to Adverse Events | 1 |
The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up
| Participants | Ibrexafungerp 750 mg |
|---|---|
| Percentage of Participants With Recurrence of Baseline Fungal Infection | 1 |
Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug)
| Participants | Ibrexafungerp 750 mg |
|---|---|
| Day 42 — Survived | 24 |
| Day 42 — Died | 4 |
| Day 42 — Unknown survival status | 2 |
| Day 84 — Survived | 19 |
| Day 84 — Died | 8 |
| Day 84 — Unknown survival status | 3 |
Collected over From signing of Informed Consent to Week 6 follow up (up to 132 Days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibrexafungerp 750mg | 8/30 (26.7%) | 11/30 (36.7%) | 25/30 (83.3%) |
| Event | Ibrexafungerp 750mg |
|---|---|
| Multiple organ dysfunction syndromeGeneral disorders | 2/30 |
| Acute kidney injuryRenal and urinary disorders | 2/30 |
| Abdominal sepsisInfections and infestations | 1/30 |
| COVID-19 PneumoniaInfections and infestations | 1/30 |
| Intervertebral discitisInfections and infestations | 1/30 |
| PneumoniaInfections and infestations | 1/30 |
| Septic shockInfections and infestations | 1/30 |
| Systemic CandidaInfections and infestations | 1/30 |
| Chest painGeneral disorders | 1/30 |
| Oedema peripheralGeneral disorders | 1/30 |
| Event | Ibrexafungerp 750mg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 11/30 |
| NauseaGastrointestinal disorders | 7/30 |
| VomitingGastrointestinal disorders | 4/30 |
| Candida infectionInfections and infestations | 4/30 |
| ConstipationGastrointestinal disorders | 3/30 |
| DyspepsiaGastrointestinal disorders | 3/30 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 3/30 |
| HypotensionVascular disorders | 3/30 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/30 |
| AnaemiaBlood and lymphatic system disorders | 3/30 |
| Age, Continuous(years) | Ibrexafungerp 750 mg |
|---|---|
| Mean | 60.3 (23.0 to 97.0) |
| Sex: Female, Male(Participants) | Ibrexafungerp 750 mg |
|---|---|
| Female | 21 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Ibrexafungerp 750 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 20 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Apr 2023, 64 months.
Results were first posted in Jul 2024, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ibrexafungerp
Scynexis, Inc.