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SCYNERGIA

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
SYC-078-2062018-002565-18

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 (SCYNERGIA)

Status: Active

Purpose / Objectives

Primary Outcome

 To evaluate the safety and tolerability of the coadministration of SCY-078 and voriconazole (“combination therapy”) compared with that of voriconazole monotherapy in the treatment of invasive pulmonary aspergillosis (IPA).

Secondary Outcomes

To evaluate the efficacy of the combination therapy compared with that of voriconazole monotherapy in the treatment of IPA.
o based on Global Response

      •  as determined by the DRC
      •  as determined by the Principal Investigator

o based on all-cause mortality (ACM)

o based on serum galactomannan index (GMI) decrease

          • based on clinical response, mycological response and radiological response  as determined by the DRC
  • as determined by the Principal Investigator

 To evaluate the pharmacokinetics (PK) of SCY-078 and voriconazole.

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

 1. Subject has a possible, probable or proven invasive pulmonary aspergillosis (IPA) based on EORTC-MSG criteria.

2. 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).

3. Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone a hematopoietic cell transplantation.

4. 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.

5. 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).

6. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.

[...]

Exclusion criteria

 1. 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 (Section 22.1) 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. Note: Subjects with unconjugated hyperbilirubinemia with a diagnosis of Gilbert’s disease are not excluded.

7. Subject has a grade II-IV acute or extensive chronic graft-versus-host disease (GvHD).

8. Subject has renal failure requiring dialysis.

9. Subject has a prolonged QTcF interval (Fridericia’s correction: QTc= QT/(RR)0.33) >480 ms on the baseline ECG or other abnormalities deemed clinically significant by the investigator that would put the subject at unacceptable risk for participation in the study.

10. 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.

11. Subject has a known hypersensitivity to SCY-078 and/or voriconazole or any of the components of the formulations.

12. Subject has participated in any other investigational study (except open-label studies including approved chemotherapy agents) within at least 28 days or 5.5 half-lives of the investigational product (whichever is longer) before signing the ICF.

13. Subject has received prior treatment with SCY-078 in a previous trial.

 

[...]

 

Trial design

  • Phase II
  • Multicenter
  • Randomized
  • Two-arm
  • Double-blind

Intervention

Combination Therapy Group (Voriconazole + SCY-078)

or

Voriconazole Monotherapy Group (Voriconazole Alone) +

 Placebo matching oral SCY-078

 

 

Documents (password protected)

Responsibilities in overall trial

SCYNEXIS Inc.

    National Coordinating Investigator

    Univ.-Prof. Dr. med. Oliver A. Cornely

    Study Sites

    Klinik I für Innere Medizin

    Study office

    Status

    Active

    Principal Investigator

    Univ.-Prof. Dr. med. Oliver A. Cornely

    Deputy of Principal Investigator

    • Dr. med. Sibylle Christiane Mellinghoff

    Subinvestigator

    • Dr. med. Philipp Köhler

    Contact at Site