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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)

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ClinicalTrials.gov Identifier: NCT03059992
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date October 25, 2019
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
Assessment of Global Response [ Time Frame: Up to 180 days of study treatment ]
The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment Visit.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
Assessment of Global Response [ Time Frame: Up to 90 days of study treatment ]
The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • Assessment of Recurrence of Baseline Fungal Infection [ Time Frame: up to 42 days after end of study treatment ]
    The proportion of subjects with a recurrence of the baseline fungal infectoin
  • Assessment of survival [ Time Frame: Day 42, Day 84 ]
    Proportion of surviving subjects
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • Assessment of Recurrence of Baseline Fungal Infection [ Time Frame: up to 42 days after end of study treatment ]
    The proportion of subjects with a recurrence of the baseline fungal infection
  • Assessment of Survival [ Time Frame: Day 42, Day 84 ]
    proportion of subjects surviving
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 16, 2017)
Assessment of Response at End of Treatment by a Data Review Committee [ Time Frame: Up to 90 days of study treatment ]
Assessment of complete and partial global response and Population PK
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Open label, non-comparator, single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Invasive Candidiasis
  • Mucocutaneous Candidiasis
  • Coccidioidomycosis
  • Histoplasmosis
  • Blastomycosis
  • Chronic Pulmonary Aspergillosis
  • Allergic Bronchopulmonary Aspergillosis
  • Invasive Pulmonary Aspergillosis
  • Recurrent Vulvovaginal Candidiasis
  • Other Emerging Fungi
Intervention  ICMJE Drug: Ibrexafungerp
Experimental Study Drug
Other Name: SCY-078
Study Arms  ICMJE Experimental: Ibrexafungerp (SCY-078)
Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
Intervention: Drug: Ibrexafungerp
Publications * Davis MR, Donnelley MA, Thompson GR. Ibrexafungerp: A novel oral glucan synthase inhibitor. Med Mycol. 2019 Jul 25. pii: myz083. doi: 10.1093/mmy/myz083. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
60
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nkechi Azie, MD 201-688-2243 nkechi.azie@scynexis.com
Contact: Kristin Bennett 201-884-5469 kristin.bennett@scynexis.com
Listed Location Countries  ICMJE Austria,   Germany,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03059992
Other Study ID Numbers  ICMJE SCY-078-301
2017-000381-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Scynexis, Inc.
Study Sponsor  ICMJE Scynexis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Angulo, MD Sponsor GmbH
PRS Account Scynexis, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP