Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000381-29 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor.
Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.
Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances.
Following a screening visit, there will be up to 15 treatment visits, a follow-up visit and 2 follow-up contacts.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Experimental | Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrexafungerp | Drug | Experimental Study Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0006 | United States | ||
| UC Davis Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31342066 | Background | Davis MR, Donnelley MA, Thompson GR. Ibrexafungerp: A novel oral glucan synthase inhibitor. Med Mycol. 2020 Jul 1;58(5):579-592. doi: 10.1093/mmy/myz083. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ibrexafungerp (SCY-078) | Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2022 | Sep 19, 2024 |
Not provided
Not provided
Open label, non-comparator, single arm
Not provided
Not provided
Not provided
Not provided
| Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Mycological Response by Disease Category | The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Mycological Response by Disease Category and Pathogen | The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Mycological Response by Fungal Disease | The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Mycological Response by Enrollment Category | The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| Percentage of Participants With a Recurrence of Baseline Fungal Disease | The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline. | 42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases. |
| Percentage of Participants Surviving at Day 30 or Day 42 | Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline. | Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases. |
| Time to Death From Any Cause | Time to death from any cause in days per Fungal Disease | Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other. |
| Describe Ibrexafungerp Plasma Concentrations | Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen: Day 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD | Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose. |
| Sacramento |
| California |
| 95817 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30322 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15203 | United States |
| University of Texas Southwestern Medical Center Dallas | Dallas | Texas | 75390-8589 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine | Graz | 8036 | Austria |
| Medical University Innsbruck | Innsbruck | 6020 | Austria |
| Universitätsklinikum Köln, Klinik I für Innere Medizin | Cologne | 50937 | Germany |
| Universitätsklinikum Essen, Klinik für Infektiologie | Essen | 45147 | Germany |
| Universitätsklinikum Frankfurt, Department of Internal Medicine II | Frankfurt | 60590 | Germany |
| Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology | Leipzig | 04129 | Germany |
| LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III | Munich | 81377 | Germany |
| Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8 | Nijmegen | Gelderland | 6525 | Netherlands |
| Aga Khan University | Karachi | 74800 | Pakistan |
| Johese Clinical Research | Lyttelton | Centurion | 0154 | South Africa |
| Into Research | Groenkloof | Pretoria | 0181 | South Africa |
| FCRN Clinical Trial Centre | Three Rivers | Vereeniging | 1935 | South Africa |
| Emmed Research | Pretoria | 0002 | South Africa |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| St. George's University of London | London | SW17 0RE | United Kingdom |
| The University of Manchester | Manchester | M13 9PL | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibrexafungerp (SCY-078) | Ibrexafungerp (SCY-078), orally administered QD for up to 180 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. | Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug. Per Protocol (PP) Population - include all ITT participants who received enough study drug to enable clinical efficacy judgement as determined by the DRC, who have an EOT or TOC (as applicable) assessment and who have no major protocol violations that could impact the assessment of efficacy. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason. | Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. | Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Mycological Response by Disease Category | The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Mycological Response by Fungal Disease | The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Mycological Response by Enrollment Category | The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. | Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Recurrence of Baseline Fungal Disease | The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline. | Intent to Treat (ITT) population (any participant who was enrolled in the study and received at least one dose of study drug) that achieved a Global Response. | Posted | Count of Participants | Participants | 42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Surviving at Day 30 or Day 42 | Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline. | Intent to Treat (ITT) Population - any participant enrolled in the study who received at least one dose of study drug. | Posted | Count of Participants | Participants | Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases. |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Death From Any Cause | Time to death from any cause in days per Fungal Disease | Safety Population - All subjects who received at least one dose of study drug and who had at least one safety assessment post-Baseline. | Posted | Median | 95% Confidence Interval | Number of days | Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other. |
|
| ||||||||||||||||||||||||||||
| Secondary | Describe Ibrexafungerp Plasma Concentrations | Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen: Day 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD | Pharmacokinetic (Pk) Population - all enrolled participants who provided at least one Pk sample and with no deviations significant enough to affect interpretation of the Pk data. | Posted | Median | Full Range | nanograms per milliliter (ng/mL) | Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose. |
|
|
Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibrexafungerp (SCY-078) | Ibrexafungerp (SCY-078), orally administered QD for up to 180 days. Ibrexafungerp: Experimental Study Drug | 15 | 233 | 102 | 233 | 215 | 233 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| B-cell type acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Blastic plasmacytoid dendritic cell neoplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis allergic | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug clearance decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Enterobacter pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HCoV-NL63 infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemic seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary vein stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stenotrophomonas bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Venoocclusive disease | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Weaning failure | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Angulo, SCYNEXIS CEO | SCYNEXIS, Inc. | 201-884-5471 | david.angulo@scynexis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2024 | Sep 17, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002178 | Candidiasis, Chronic Mucocutaneous |
| D003047 | Coccidioidomycosis |
| D006660 | Histoplasmosis |
| D001759 | Blastomycosis |
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| D055744 | Invasive Pulmonary Aspergillosis |
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
| D003881 | Dermatomycoses |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008172 | Lung Diseases, Fungal |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C569338 | ibrexafungerp |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Evaluable |
|
| Overall Study (PP) |
|
|
| Acute Invasive Candidiasis including Candidemia (ITT) |
|
|
| Acute Invasive Candidiasis including Candidemia (PP) |
|
|
| Chronic Invasive Candidiasis (ITT) |
|
|
| Chronic Invasive Candidiasis (PP) |
|
|
| Esophageal Candidiasis (ITT) |
|
|
| Esophageal Candidiasis (PP) |
|
|
| Oropharyngeal Candidiasis (ITT) |
|
|
| Oropharyngeal Candidiasis (PP) |
|
|
| Chronic Mucocutaneous Candidiasis (ITT) |
|
|
| Chronic Mucocutaneous Candidiasis (PP) |
|
|
| Vulvovaginal Candidiasis (ITT) |
|
|
| Vulvovaginal Candidiasis (PP) |
|
|
| Disseminated/Invasive Dimorphic Fungi (ITT) |
|
|
| Disseminated/Invasive Dimorphic Fungi (PP) |
|
|
| Chronic Pulmonary Aspergillosis (ITT) |
|
|
| Chronic Pulmonary Aspergillosis (PP) |
|
|
| Allergic Bronchopulmonary Aspergillosis (ITT) |
|
|
| Allergic Bronchopulmonary Aspergillosis (PP) |
|
|
| Invasive Pulmonary Aspergillosis (ITT) |
|
|
| Invasive Pulmonary Aspergillosis (PP) |
|
|
| Other Emerging Fungi (ITT) |
|
|
| Other Emerging Fungi (PP) |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
|
|
|
|
|
|
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
| No Response |
|
|
|
|
|
|
|
|