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    Summary
    EudraCT Number:2017-000381-29
    Sponsor's Protocol Code Number:SCY-078-301
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-000381-29
    A.3Full title of the trial
    Open-Label Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients with Fungal Diseases that are Refractory to, Resistant or Intolerant of Standard Antifungal Treatment (FURI)
    Open-Label-Studie zur Bewertung der Wirksamkeit und Sicherheit von Ibrexafungerp bei Patienten mit Pilzkrankheiten, die refraktär, resistent oder intolerant gegenüber Standard-Antipilz-Behandlung (FURI) sind.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test effectiveness and safety of a new drug, Ibrexafungerp in patients with fungal diseases who do not easily respond to, are resistant to or who are intolerant to, the current treatment for their disease.
    Open-Label-Studie zur Bewertung der Wirksamkeit und Sicherheit von Ibrexafungerp bei Patienten mit Pilzkrankheiten, die unempfänglich, resistent oder intolerant gegenüber Standard-Antipilz-Behandlung (FURI) sind.
    A.4.1Sponsor's protocol code numberSCY-078-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03059992
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSCYNEXIS, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSCYNEXIS Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC Cologne
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressGleueler Str. 269
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50935
    B.5.3.4CountryGermany
    B.5.4Telephone number0049221478 88793
    B.5.5Fax number0049221478 88209
    B.5.6E-mailsabine.schleicher1@uk-koeln.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIbrexafungerp
    D.3.2Product code SCY-078
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBREXAFUNGERP
    D.3.9.1CAS number 1965291-08-0
    D.3.9.2Current sponsor codeSCY-078
    D.3.9.3Other descriptive nameMK-3118
    D.3.9.4EV Substance CodeSUB193372
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients > 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant, resistant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
    E.1.1.1Medical condition in easily understood language
    severe fungal diseases who do not easily respond to, are resistant or who are intolerant to, the current treatment for their disease.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the efficacy of ibrexafungerp in the treatment of severe fungal diseases by a Data Review Committee (DRC) at the primary
    timepoint for the fungal disease
    •To evaluate safety of ibrexafungerp.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of ibrexafungerp as determined by the DRC at other time points
    • To evaluate the efficacy of ibrexafungerp as determined by the Investigator
    • To determine the efficacy of ibrexafungerp by pathogen
    • To determine the efficacy of ibrexafungerp by fungal disease and disease category (type of fungal disease)
    • To evaluate the efficacy of ibrexafungerp by recurrence of the baseline fungal disease
    • To evaluate the efficacy of ibrexafungerp by reason for enrollment (refractory, resistance, relapse, intolerance, toxicity, need for oral therapy)
    • To determine All-Cause Mortality (ACM)
    • To evaluate the pharmacokinetics (PK) of ibrexafungerp by population PK analysis
    • To evaluate the efficacy of ibrexafungerp as determined by other disease-specific endpoints
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is a male or female adult ≥18 years of age on the day the study informed consent form (ICF) is signed.
    2. Subject has a documented eligible fungal disease that has been refractory or resistant to SOC, has relapsed after, or the subject has intolerance to or demonstrated toxicities resulting from an approved SOC antifungal treatment (as defined in study protocol Table 5). The subject is also eligible if, in the judgement of the Investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical (isolate is resistant to or has a high MIC and is unlikely to respond to antifungal SOC) or logistical circumstances or if other antifungal alternatives are not appropriate.
    3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.
    4. Subject and/or legal guardian is/are able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures.
    5. Subject and/or legal guardian is 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 US, a Health Insurance Portability and Accountability Act [HIPAA] authorization form).
    6. Subject and/or legal guardian is able to understand and follow all study-related procedures including study drug administration.
    7. Subject is not pregnant and is highly unlikely to become pregnant or to impregnate a partner since he/she meets at least one of the following criteria:
    a. Subject is a female subject who is not of reproductive potential and is eligible without requiring the use of contraception.
    b. Subject is a male subject who is not of reproductive potential and is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as one who has undergone a successful vasectomy.
    c. Subject is a male or female subject who is of reproductive potential and agrees to remain abstinent if it is the subject's preferred method of contraception, or, if sexually active, use (or have their partner use) 2 acceptable methods of contraception starting from the time of consent through 28 days after the completion of study therapy.
    E.4Principal exclusion criteria
    1. Subject has an invasive fungal disease with central nervous system involvement unless the subject is planned to receive combination therapy with ibrexafungerp and other antifungal.
    2. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters, devices, identified undrained abscess) that is likely to be the source of the fungal disease.
    3. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
    4. Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5 x ULN.
    5. Subject is unlikely to survive 30 days.
    6. Subject has any other condition or laboratory abnormality that, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
    7. Subject requires treatment with the prohibited medications.
    8. Subject has known hypersensitivity to ibrexafungerp.
    9. Subject is pregnant or lactating.
    10. Subject has received any other investigational drug (i.e., new chemical entity) within at least 30 days (or 5 and a half half-lives of the investigational product) before signing the ICF.
    11. Subject is an employee of SCYNEXIS, Inc., the Investigator, or contract research organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
    12. Subject or legal representative is/are unable to provide written informed consent for any reason.
    13. Subject is unlikely to comply with protocol requirements.
    E.5 End points
    E.5.1Primary end point(s)
    • Efficacy as measured by the percentage of subjects with Global Response at TOC for VVC (Day 17), CMC (EOT or Day 84), CPA (EOT or
    Day 90) and ABPA (EOT or Day 90) (whichever comes first) and at EOT for all other diseases as determined by a DRC
    • Safety as measured by: physical examination, vital signs, AEs, and laboratory tests
    E.5.1.1Timepoint(s) of evaluation of this end point
    TOC for VVC (Day 17), CMC (EOT or Day 84), CPA (EOT or Day 90) and ABPA (EOT or Day 90) (whichever comes first) and at EOT for all other diseases
    E.5.2Secondary end point(s)
    • The percentage of subjects who achieve Global Response at additional time points as applicable for each disease, disease category and reason for enrollment (Table 16), as determined by the DRC and by the Investigator
    • The percentage of subjects who achieve Clinical Response by pathogen at time points applicable for each disease, disease category and reason for enrollment (Table 16), as determined by the DRC and the Investigator
    • The percentage of subjects who achieve Mycological Response by pathogen at time points applicable for each disease, disease category and reason for enrollment (Table 16), as determined by the DRC and the Investigator
    • The percentage of subjects who achieve Clinical Response by fungal disease, disease category and reason for enrollment at time points applicable for each disease (Table 16), as determined by the DRC and the Investigator
    • The percentage of subjects who achieve Mycological Response by disease category (type of fungal disease) at time points applicable for each disease (Table 16), as determined by the DRC and the Investigator
    • The percentage of subjects with a recurrence of the baseline fungal disease at the 25-Day FU for VVC and at the 6-Week FU for all other diseases as determined by the DRC
    • ACM at Day 30 (Invasive candidiasis and candidemia) and Day 42 for all diseases
    • Time to death from any cause
    • Describe ibrexafungerp plasma concentrations
    • Disease-specific secondary endpoints, as assessed by the DRC (See table 2 in study protocol)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Acute or chronic invasive candidiasis, including candidemia : EoT, D 42, 6-Week FU
    Acute or chronic severe mucocutaneous candidiasis, including EC+OPC: EOT, D42 ,6Week FU; For CMC: TOC (D84 or EOT, whichever occurs first) (EOT, D42, D84, 6Week FU)
    Vulvovaginal candidiasis: D17, 25-D FU [D32], 35D FU [D 42])
    Disseminated/invasive dimorphic fungi: EOT, D42, D84, 6-Week FU Chronic Pulmonary Aspergillosis: TOC(D90 or EOT, whichever occurs first)EOT, D90, D180, every 3 months while on Tx if beyond D 180, 6-Week FU
    Allergic Bronchopulmonary Aspergillosis: TOC(D90 or EOT, whichever occurs first)EOT, D90, D180, every 3 months while on Tx if beyond D180, 6-Week FU
    Invasive Pulmonary Aspergillosis: EOT, D42, D84, 6Week FU Other emerging fungi including yeasts and molds: EOT, D42, D84, 6-Week FU
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Pakistan
    South Africa
    United States
    Austria
    Germany
    Netherlands
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    emergency patients may be recruited into the study
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-17
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