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 |
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Recruitment Status :
Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : January 27, 2023
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| 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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| 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 : | June 30, 2023 |
| Estimated Study Completion Date : | August 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ibrexafungerp (SCY-078)
Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
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Drug: Ibrexafungerp
Experimental Study Drug
Other Name: SCY-078 |
- 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.
- 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
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
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| Study Director: | David Angulo, MD | Sponsor GmbH |
| Responsible Party: | Scynexis, Inc. |
| ClinicalTrials.gov Identifier: | NCT03059992 |
| Other Study ID Numbers: |
SCY-078-301 2017-000381-29 ( EudraCT Number ) |
| First Posted: | February 23, 2017 Key Record Dates |
| Last Update Posted: | January 27, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Candidiasis Aspergillosis Candidiasis, Vulvovaginal Candidiasis, Invasive Pulmonary Aspergillosis Invasive Pulmonary Aspergillosis Histoplasmosis Aspergillosis, Allergic Bronchopulmonary Mycoses Coccidioidomycosis Coccidiosis Blastomycosis Candidiasis, Chronic Mucocutaneous Bacterial Infections and Mycoses Infections |
Vulvovaginitis Vaginitis Vaginal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Vulvitis Vulvar Diseases Genital Diseases Invasive Fungal Infections Lung Diseases, Fungal Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |