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

NCT ID: NCT03059992

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2023-08-25

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ibrexafungerp

Intervention Type: DRUG

Experimental Study Drug

Interventions

Ibrexafungerp

Experimental Study Drug

Intervention Type: DRUG

Other Intervention Names

SCY-078

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scynexis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

UC Davis Medical Center

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center Dallas

Dallas, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States

Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine

Graz, , Austria

Medical University Innsbruck

Innsbruck, , Austria

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, , Germany

Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8

Nijmegen, Gelderland, Netherlands

Aga Khan University

Karachi, , Pakistan

Johese Clinical Research

Lyttelton, Centurion, South Africa

Into Research

Groenkloof, Pretoria, South Africa

FCRN Clinical Trial Centre

Three Rivers, Vereeniging, South Africa

Emmed Research

Pretoria, , South Africa

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

St. George's University of London

London, , United Kingdom

The University of Manchester

Manchester, , United Kingdom

Countries

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

References

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.

Reference Type: BACKGROUND

PMID: 31342066 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-000381-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SCY-078-301

Identifier Type: -

Identifier Source: org_study_id