Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)
Overview
- Phase
- Phase 3
- Intervention
- Ibrexafungerp
- Conditions
- Invasive Candidiasis
- Sponsor
- Scynexis, Inc.
- Enrollment
- 233
- Locations
- 37
- Primary Endpoint
- Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment
- •Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube
- •Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
- •Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form).
- •Be able to understand and follow all study-related procedures including study drug administration.
- •Agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Exclusion Criteria
- •An invasive fungal disease with CNS involvement.
- •Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection).
- •Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support.
- •A life expectancy \< 30 days.
- •Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>10 x the upper limit of normal (ULN), and/or total bilirubin \> 5 x ULN.
- •Subject is pregnant or lactating.
- •Subject has used an investigational drug within 30 days prior to the baseline visit.
Arms & Interventions
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.
Intervention: Ibrexafungerp
Outcomes
Primary Outcomes
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.
Time Frame: 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.
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.
Secondary Outcomes
- Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category(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.(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(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(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(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(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(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(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(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(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(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(Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases.)
- Time to Death From Any Cause(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(Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose.)