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Study to Evaluate the Safety and Efficacy of the Combination Therapy of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis (SCYNERGIA)

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ClinicalTrials.gov Identifier: NCT03672292
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Brief Summary:
Study to evaluate the safety and efficacy of combination therapy of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole mono-therapy in patients with invasive pulmonary aspergillosis.

Condition or disease Intervention/treatment Phase
Invasive Pulmonary Aspergillosis Drug: SCY-078 Drug: Voriconazole Other: Oral Placebo Tablets Phase 2

Detailed Description:
This is a multicenter, randomized, double-blind, two-arm study to evaluate the safety, tolerability, efficacy and PK of the combination therapy of SCY-078 plus voriconazole compared to those of voriconazole monotherapy in male and female subjects 18 years of age and older with a hematological malignancy (HM) or a myelodysplastic syndrome or aplastic anemia or hematopoietic cell transplantation (HCT) and a probable or proven invasive pulmonary aspergillosis based on EORTCMSG criteria. In addition, all subjects must be positive (≥0.5) for serum GMI.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Combination Therapy of SCY-078 With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: SCY-078 plus Voriconazole

Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).

PLUS Oral SCY-078 tablets (loading dose of 750 mg BID on Days 1 and 2 followed by maintenance dose of 750 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks

Drug: SCY-078
Oral tablets of SCY-078
Other Name: Ibrexafungerp

Drug: Voriconazole
Voriconazole IV vials or oral tablets

Active Comparator: Voriconazole mono-therapy

Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).

PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 3 tablets given BID on Days 1 and 2 followed by maintenance dose of 3 tablets given QD from Day 3 onwards).

Treatment duration = minimum 6 weeks/Max 13 weeks

Drug: Voriconazole
Voriconazole IV vials or oral tablets

Other: Oral Placebo Tablets
Oral Placebo Tablets matching SCY-078
Other Name: SCY-078 matching Placebo




Primary Outcome Measures :
  1. Adverse events; discontinuation due to AE; death [ Time Frame: through study completion, an average of 19 weeks ]
    Frequency of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs and deaths.


Secondary Outcome Measures :
  1. Composite clinical, radiological and mycological response (global response) [ Time Frame: At end of treatment, day 42 and day 84 ]
    Percentage of subjects with Complete Response or Partial Response

  2. Death [ Time Frame: At Day 42 and Day 84 ]
    Percentage of subjects who died (any cause)

  3. Change in serum GMI [ Time Frame: Weeks 1, 2, 4 and 6 ]
    Absolute and percent change in serum GMI from Baseline

  4. Study drug and comparator plasma concentrations [ Time Frame: Through the first 2 weeks of study ]
    SCY-078 and voriconazole plasma concentrations population PK analysis



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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

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 probable or proven IPA based on EORTC-MSG criteria.
  3. Subject has a result of a serum GMI ≥0.5 from a sample obtained within the 96 hours preceding enrollment into the study (Baseline/Treatment Day 1).
  4. Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation.
  5. Subject has not received more than 4 days (96 hours) of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study (Baseline/Treatment Day 1). However, subjects who have received more than 4 days but less than 7 days of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study may be enrolled but will require approval from the study medical monitor, who will evaluate each subject on a case-by-case basis.
  6. Subject has an IPA episode that, in the investigator´s judgement, requires antifungal therapy and may be adequately treated with voriconazole (i.e., the IPA is not a breakthrough infection while receiving a mold-active azole antifungal [voriconazole, posaconazole, isavuconazole or itraconazole] that requires therapy with a non-azole antifungal agent).

Exclusion Criteria:

Subject has a fungal disease with central nervous system involvement suspected at Screening. 2. Subject is receiving, has received or anticipates to be receiving concomitant medications that are listed in the prohibited medication list (Appendix A in full protocol) within the specified washout periods. 3. Subject has a Karnofsky score <20. 4. Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed. 5. Subject is under mechanical ventilation. 6. Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5 x ULN.


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): NCT03672292


Contacts
Contact: David Angulo, MD 201 884-5471 ext 5471 david.angulo@scynexis.com
Contact: Mihaela Tufa, MD 201 884-5899 ext 5899 mihaela.tufa@scynexis.com

Sponsors and Collaborators
Scynexis, Inc.
Investigators
Study Director: David Angulo, MD Scynexis, Inc.

Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03672292     History of Changes
Other Study ID Numbers: SCY-078-206
2018-002565-18 ( EudraCT Number )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
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

Keywords provided by Scynexis, Inc.:
Aspergillosis
SCY-078
Ibrexafungerp
Combination

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Invasive Fungal Infections
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors