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 Clinical Trial

— FURI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059992
• Other study ID #: SCY-078-301
• Secondary ID: 2017-000381-29
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2017
• Est. completion date: August 17, 2023

Study information

• Verified date: October 2023
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: August 17, 2023
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ibrexafungerp
Experimental Study Drug

Locations

Country	Name	City	State
Austria	Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine	Graz
Austria	Medical University Innsbruck	Innsbruck
Germany	Universitätsklinikum Köln, Klinik I für Innere Medizin	Cologne
Germany	Universitätsklinikum Essen, Klinik für Infektiologie	Essen
Germany	Universitätsklinikum Frankfurt, Department of Internal Medicine II	Frankfurt
Germany	Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology	Leipzig
Germany	LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III	Munich
Netherlands	Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8	Nijmegen	Gelderland
Pakistan	Aga Khan University	Karachi
South Africa	Into Research	Groenkloof	Pretoria
South Africa	Johese Clinical Research	Lyttelton	Centurion
South Africa	Emmed Research	Pretoria
South Africa	FCRN Clinical Trial Centre	Three Rivers	Vereeniging
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United Kingdom	St. George's University of London	London
United Kingdom	The University of Manchester	Manchester
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Texas Southwestern Medical Center Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	UC Davis Medical Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California San Francisco	San Francisco	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Netherlands,  Pakistan,  South Africa,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Global Response	The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment Visit.	Up to 180 days of study treatment
Secondary	Assessment of Recurrence of Baseline Fungal Infection	The proportion of subjects with a recurrence of the baseline fungal infectoin	up to 42 days after end of study treatment
Secondary	Assessment of survival	Proportion of surviving subjects	Day 42, Day 84