Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

• ClinicalTrials.gov Identifier: NCT03059992
• Recruitment Status: Completed
• First Posted: February 23, 2017
• Last Update Posted: April 29, 2024
• Sponsor: Scynexis, Inc.
• Information provided by (Responsible Party): Scynexis, Inc.

Tracking Information

• First Submitted Date: February 14, 2017
• First Posted Date: February 23, 2017
• Last Update Posted Date: April 29, 2024
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: August 17, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2019)

Assessment of Global Response [ Time Frame: Up to 180 days of study treatment ]

The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment Visit.

Original Primary Outcome Measures (submitted: February 16, 2017)

Assessment of Global Response [ Time Frame: Up to 90 days of study treatment ]

The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment visit.

Current Secondary Outcome Measures (submitted: August 21, 2017)

• Assessment of Recurrence of Baseline Fungal Infection [ Time Frame: up to 42 days after end of study treatment ]
  The proportion of subjects with a recurrence of the baseline fungal infectoin
• Assessment of survival [ Time Frame: Day 42, Day 84 ]
  Proportion of surviving subjects

Original Secondary Outcome Measures (submitted: February 16, 2017)

• Assessment of Recurrence of Baseline Fungal Infection [ Time Frame: up to 42 days after end of study treatment ]
  The proportion of subjects with a recurrence of the baseline fungal infection
• Assessment of Survival [ Time Frame: Day 42, Day 84 ]
  proportion of subjects surviving

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: February 16, 2017)

Assessment of Response at End of Treatment by a Data Review Committee [ Time Frame: Up to 90 days of study treatment ]

Assessment of complete and partial global response and Population PK

Descriptive Information

• Brief Title: Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
• Official Title: 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)
• 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.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open label, non-comparator, single arm

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Invasive Candidiasis
• Mucocutaneous Candidiasis
• Coccidioidomycosis
• Histoplasmosis
• Blastomycosis
• Chronic Pulmonary Aspergillosis
• Allergic Bronchopulmonary Aspergillosis
• Invasive Pulmonary Aspergillosis
• Recurrent Vulvovaginal Candidiasis
• Other Emerging Fungi

Intervention

Drug: Ibrexafungerp

Experimental Study Drug

Other Name: SCY-078

Study Arms

Experimental: Ibrexafungerp (SCY-078)

Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.

Intervention: Drug: Ibrexafungerp

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2023): 233
• Original Estimated Enrollment (submitted: February 16, 2017): 60
• Actual Study Completion Date: August 17, 2023
• Actual Primary Completion Date: August 17, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

1. Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment
2. Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube
3. Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
4. 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).
5. Be able to understand and follow all study-related procedures including study drug administration.
6. Agree to use a medically acceptable method of contraception while receiving protocol-assigned product.

Key Exclusion Criteria:

1. An invasive fungal disease with CNS involvement.
2. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection).
3. Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support.
4. A life expectancy < 30 days.
5. 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.
6. Subject is pregnant or lactating.
7. Subject has used an investigational drug within 30 days prior to the baseline visit.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Netherlands, Pakistan, South Africa, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03059992
• Other Study ID Numbers: SCY-078-301; 2017-000381-29 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Scynexis, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Scynexis, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Scynexis, Inc.
• Verification Date: October 2023