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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.

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.

Condition or disease Intervention/treatment Phase
Invasive Candidiasis Mucocutaneous Candidiasis Coccidioidomycosis Histoplasmosis Blastomycosis Chronic Pulmonary Aspergillosis Allergic Bronchopulmonary Aspergillosis Invasive Pulmonary Aspergillosis Recurrent Vulvovaginal Candidiasis Other Emerging Fungi Drug: Ibrexafungerp Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, non-comparator, single arm
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Ibrexafungerp (SCY-078)
Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
Drug: Ibrexafungerp
Experimental Study Drug
Other Name: SCY-078




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Assessment of survival [ Time Frame: Day 42, Day 84 ]
    Proportion of surviving subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059992


Contacts
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Contact: Nkechi Azie, MD 201-688-2243 nkechi.azie@scynexis.com
Contact: Kristin Bennett 201-884-5469 kristin.bennett@scynexis.com

  Show 30 Study Locations
Sponsors and Collaborators
Scynexis, Inc.
Investigators
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Study Director: David Angulo, MD Sponsor GmbH

Publications:
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Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03059992     History of Changes
Other Study ID Numbers: SCY-078-301
2017-000381-29 ( EudraCT Number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis
Aspergillosis
Candidiasis, Invasive
Candidiasis, Vulvovaginal
Pulmonary Aspergillosis
Histoplasmosis
Invasive Pulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Mycoses
Coccidioidomycosis
Blastomycosis
Candidiasis, Chronic Mucocutaneous
Coccidiosis
Invasive Fungal Infections
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Protozoan Infections
Parasitic Diseases