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 : September 25, 2020
|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|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label, non-comparator, single arm|
|Masking:||None (Open Label)|
|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|
Experimental: Ibrexafungerp (SCY-078)
Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
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
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
|Contact: Nkechi Azie, MDfirstname.lastname@example.org|
|Contact: Kristin Bennettemail@example.com|
|Study Director:||David Angulo, MD||Sponsor GmbH|