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

Last updated: October 28, 2024
Sponsor: Scynexis, Inc.
Overall Status: Completed

Phase

3

Condition

Gynecological Infections

Sexually Transmitted Diseases (Stds)

Fungal Infections

Treatment

Ibrexafungerp

Clinical Study ID

NCT03059992
SCY-078-301
2017-000381-29
  • Ages > 18
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  1. Must have a documented eligible invasive and/or severe fungal disease that isrefractory or intolerant to Standard-of-Care treatment

  2. Be able to tolerate medication orally or through a nasogastric (NG) tube orpercutaneous endoscopic gastrostomy (PEG) tube

  3. Be able to understand and sign a written informed consent form (ICF), which must beobtained prior to treatment and any study-related procedures.

  4. Be able to understand and sign a consent or authorization form which shall permitthe 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 drugadministration.

  6. Agree to use a medically acceptable method of contraception while receivingprotocol-assigned product.

Exclusion

Key Exclusion Criteria:

  1. An invasive fungal disease with CNS involvement.

  2. Subject has an inappropriately controlled fungal disease source (e.g., persistentcatheters that cannot be removed and are likely the source of infection).

  3. Subject is hemodynamically unstable, requiring vasopressor medication for bloodpressure 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 totalbilirubin > 5 x ULN.

  6. Subject is pregnant or lactating.

  7. Subject has used an investigational drug within 30 days prior to the baseline visit.

Study Design

Total Participants: 233
Treatment Group(s): 1
Primary Treatment: Ibrexafungerp
Phase: 3
Study Start date:
April 01, 2017
Estimated Completion Date:
August 25, 2023

Study 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.

Connect with a study center

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

    Graz, 8036
    Austria

    Site Not Available

  • Medical University Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Universitätsklinikum Köln, Klinik I für Innere Medizin

    Cologne, 50937
    Germany

    Site Not Available

  • Universitätsklinikum Essen, Klinik für Infektiologie

    Essen, 45147
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt, Department of Internal Medicine II

    Frankfurt, 60590
    Germany

    Site Not Available

  • Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology

    Leipzig, 04129
    Germany

    Site Not Available

  • LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III

    Munich, 81377
    Germany

    Site Not Available

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

    Nijmegen, Gelderland 6525
    Netherlands

    Site Not Available

  • Aga Khan University

    Karachi, 74800
    Pakistan

    Site Not Available

  • Johese Clinical Research

    Lyttelton, Centurion 0154
    South Africa

    Site Not Available

  • Into Research

    Groenkloof, Pretoria 0181
    South Africa

    Site Not Available

  • Emmed Research

    Muckleneuck, Pretoria 0002
    South Africa

    Site Not Available

  • Emmed Research

    Muckleneuk, Pretoria 0002
    South Africa

    Site Not Available

  • FCRN Clinical Trial Centre

    Three Rivers, Vereeniging 1935
    South Africa

    Site Not Available

  • Emmed Research

    Pretoria, 0002
    South Africa

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • St. George's University of London

    London, SW17 0RE
    United Kingdom

    Site Not Available

  • The University of Manchester

    Manchester, M13 9PL
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-0006
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Emory University Hospital Midtown

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Louisiana State University Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania 15203
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37325
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center Dallas

    Dallas, Texas 75390-8589
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Site Not Available

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