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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)

Primary Purpose

Invasive Candidiasis, Mucocutaneous Candidiasis, Coccidioidomycosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrexafungerp
Sponsored by
Scynexis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • UC Davis Medical Center
  • University of California San Francisco
  • Emory University Hospital Midtown
  • Augusta University
  • Massachusetts General Hospital
  • University of Michigan
  • Wayne State University
  • University of Minnesota
  • Mayo Clinic
  • Washington University School of Medicine
  • Memorial Sloan Kettering Cancer Center
  • Weill Cornell Medical College
  • Stony Brook University Medical Center
  • Duke University Medical Center
  • Wake Forest Baptist Medical Center
  • University of Pittsburg Medical Center
  • University of Texas Southwestern Medical Center Dallas
  • University of Texas Health Science Center at Houston
  • University of Wisconsin
  • Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine
  • Medical University Innsbruck
  • Universitätsklinikum Köln, Klinik I für Innere Medizin
  • Universitätsklinikum Essen, Klinik für Infektiologie
  • Universitätsklinikum Frankfurt, Department of Internal Medicine II
  • Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology
  • LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III
  • Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8
  • Aga Khan University
  • Johese Clinical Research
  • Into Research
  • Emmed Research
  • FCRN Clinical Trial Centre
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitari i Politecnic La Fe
  • St. George's University of London
  • The University of Manchester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibrexafungerp (SCY-078)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of Recurrence of Baseline Fungal Infection
The proportion of subjects with a recurrence of the baseline fungal infectoin
Assessment of survival
Proportion of surviving subjects

Full Information

First Posted
February 14, 2017
Last Updated
January 25, 2023
Sponsor
Scynexis, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03059992
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
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Candidiasis, Mucocutaneous Candidiasis, Coccidioidomycosis, Histoplasmosis, Blastomycosis, Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis, Invasive Pulmonary Aspergillosis, Recurrent Vulvovaginal Candidiasis, Other Emerging Fungi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open label, non-comparator, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ibrexafungerp (SCY-078)
Arm Type
Experimental
Arm Description
Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
Intervention Type
Drug
Intervention Name(s)
Ibrexafungerp
Other Intervention Name(s)
SCY-078
Intervention Description
Experimental Study Drug
Primary Outcome Measure Information:
Title
Assessment of Global Response
Description
The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment Visit.
Time Frame
Up to 180 days of study treatment
Secondary Outcome Measure Information:
Title
Assessment of Recurrence of Baseline Fungal Infection
Description
The proportion of subjects with a recurrence of the baseline fungal infectoin
Time Frame
up to 42 days after end of study treatment
Title
Assessment of survival
Description
Proportion of surviving subjects
Time Frame
Day 42, Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Angulo, MD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States
Facility Name
University of Texas Southwestern Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8589
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitätsklinikum Köln, Klinik I für Innere Medizin
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Essen, Klinik für Infektiologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Frankfurt, Department of Internal Medicine II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Aga Khan University
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
Johese Clinical Research
City
Lyttelton
State/Province
Centurion
ZIP/Postal Code
0154
Country
South Africa
Facility Name
Into Research
City
Groenkloof
State/Province
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Emmed Research
City
Muckleneuck
State/Province
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
FCRN Clinical Trial Centre
City
Three Rivers
State/Province
Vereeniging
ZIP/Postal Code
1935
Country
South Africa
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
St. George's University of London
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
The University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31342066
Citation
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.
Results Reference
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Learn more about this trial

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

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