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

NCT03059992 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: SCY-078-3012017-000381-29
• Study Type: interventional
• Target: 233
• Locations: 8 countries
• Sites: 37

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.

  The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.

  Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

Secondary Outcomes (14)

• Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category

  Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

• Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.

  Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

• Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category

  Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

• Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen

  Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

• Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease

  Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

Study Arms (1)

Ibrexafungerp (SCY-078)

EXPERIMENTAL

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.

Drug: Ibrexafungerp

Interventions

Ibrexafungerp DRUG

Experimental Study Drug

Also known as: SCY-078

Ibrexafungerp (SCY-078)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \< 30 days.
• 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.
• Subject is pregnant or lactating.
• Subject has used an investigational drug within 30 days prior to the baseline visit.

Sponsors & Collaborators

• Scynexis, Inc.: lead

Study Sites (37)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0006, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15203, United States

Location

University of Texas Southwestern Medical Center Dallas

Dallas, Texas, 75390-8589, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

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

Graz, 8036, Austria

Location

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Universitätsklinikum Köln, Klinik I für Innere Medizin

Cologne, 50937, Germany

Location

Universitätsklinikum Essen, Klinik für Infektiologie

Essen, 45147, Germany

Location

Universitätsklinikum Frankfurt, Department of Internal Medicine II

Frankfurt, 60590, Germany

Location

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

Leipzig, 04129, Germany

Location

LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III

Munich, 81377, Germany

Location

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

Nijmegen, Gelderland, 6525, Netherlands

Location

Aga Khan University

Karachi, 74800, Pakistan

Location

Johese Clinical Research

Lyttelton, Centurion, 0154, South Africa

Location

Into Research

Groenkloof, Pretoria, 0181, South Africa

Location

FCRN Clinical Trial Centre

Three Rivers, Vereeniging, 1935, South Africa

Location

Emmed Research

Pretoria, 0002, South Africa

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

St. George's University of London

London, SW17 0RE, United Kingdom

Location

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Related 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.

  PMID: 31342066 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Invasive; Candidiasis, Chronic Mucocutaneous; Coccidioidomycosis; Histoplasmosis; Blastomycosis; Aspergillosis, Allergic Bronchopulmonary; Invasive Pulmonary Aspergillosis; Candidiasis, Vulvovaginal

Interventions

ibrexafungerp

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Dermatomycoses; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Pulmonary Aspergillosis; Aspergillosis; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. David Angulo, SCYNEXIS CEO
• Organization: SCYNEXIS, Inc.

david.angulo@scynexis.com

201-884-5471

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, non-comparator, single arm

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: April 1, 2017
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); ES (2); PA (1); NL (1); US (20); GB (2); ZA (4); DE (5)