Phase 3
N=233
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
Invasive Candidiasis · Mucocutaneous Candidiasis · Coccidioidomycosis · Histoplasmosis · Blastomycosis
Bottom Line
View on ClinicalTrials.gov: NCT03059992 ↗Enrolled (actual)
233
Serious AEs
43.8%
Results posted
Nov 2024
Primary outcome: Primary: Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. — 142; 69; 22; 131 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibrexafungerp (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Scynexis, Inc.
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. |
142; 69; 22; 131; 59; 5 | — |
| SECONDARY Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category |
74; 41; 13; 95; 29; 10 | — |
| SECONDARY Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. |
70; 22; 12; 52; 19; 4 | — |
| SECONDARY Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category |
57; 16; 29; 2; 25; 5 | — |
| SECONDARY Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen |
11; 7; 8; 6; 1; 3 | — |
| SECONDARY Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease |
30; 10; 19; 2; 27; 6 | — |
| SECONDARY Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category |
57; 29; 13; 29; 75; 23 | — |
| SECONDARY Percentage of Participants With a Mycological Response by Disease Category |
20; 14; 70; 11; 13; 51 | — |
| SECONDARY Percentage of Participants With a Mycological Response by Disease Category and Pathogen |
3; 6; 17; 1; 2; 6 | — |
| SECONDARY Percentage of Participants With a Mycological Response by Fungal Disease |
16; 10; 35; 4; 4; 35 | — |
| SECONDARY Percentage of Participants With a Mycological Response by Enrollment Category |
21; 33; 74; 28; 19; 87 | — |
| SECONDARY Percentage of Participants With a Recurrence of Baseline Fungal Disease |
0; 35; 5; 0; 29; 1 | — |
| SECONDARY Percentage of Participants Surviving at Day 30 or Day 42 |
39; 1; 1; 43; 0; 0 | — |
| SECONDARY Time to Death From Any Cause |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Describe Ibrexafungerp Plasma Concentrations |
479; 644; 571 | — |
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.
Eligibility Criteria
Key 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.
Key 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 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.
Data sourced from ClinicalTrials.gov (NCT03059992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.