Trial · NCT03672292
Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
NCT03672292, Phase 2, Terminated, Scynexis, Inc.; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis. Trials, record NCT03672292. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03672292
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
- NCT number
- NCT03672292
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Scynexis, Inc.
- Conditions
- Invasive Pulmonary Aspergillosis
- Interventions
- SCY-078, Voriconazole, Oral Placebo Tablets
- First posted
- 2018-09-14
- Last updated
- 2024-08-09
- Other registries' IDs
- eudract:2018-002565-18
- Results first posted
- 2024-08-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | Up to a maximum of 19 weeks | Number of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs and deaths. |
| Secondary | Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC) | At end of treatment (up to 13 weeks), day 42 and day 84 | Number and percentage of participants with Complete Response or Partial Response as determined by the Data Review Committee (DRC). Complete Response: Survival and resolution of all attributable symptoms and signs of disease; plus, successful radiological outcome; plus, mycological eradication. Partial Response: Survival and partial resolution of attributable symptoms and signs of disease; plus, improvement (at least 25%) of radiological lesions; plus, mycological eradication. |
| Secondary | Percentage of Participants Who Died (Any Cause) | At Day 42 and Day 84 | Number and Percentage of participants who died (any cause) |
| Secondary | Change in Serum Galactomannan Index (GMI) | Weeks 1, 2, 4 and 6 | Absolute change in serum GMI from from baseline to each time point (Weeks 1, 2, 4 and 6). Negative values indicate a reduction of GMI (i.e., improvement). |
| Secondary | Percent of Participants With Changes in GMI | Weeks 1, 2, 4 and 6 from Baseline | Percentage of participants with the following changes in GMI values from Baseline: * Fifty percent reduction or greater at Weeks 1, 2, 4 and 6 * Twenty-five percent reduction or greater at Weeks 1, 2, 4 and 6 * Any percent reduction at Weeks 1, 2, 4 and 6 * Reduction equal to or greater than 0.25 at Weeks 1, 2, 4 and 6 * Reduction to \< 0.5 at Weeks 1, 2, 4 and 6 |
| Secondary | Time to Achieve Serum GMI Change From Baseline | Up to a maximum of 19 weeks | Time (days) to achieve the following changes in serum GMI from Baseline: * Fifty percent reduction * Twenty-five percent reduction * Any percent reduction * Reduction equal to or greater than 0.25 |
| Secondary | Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC | End of Treatment (EoT), Day 42 and Day 84 | Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the DRC * Mycological Response at EoT, Day 42 and Day 84, as determined by the DRC * Radiological Response at EoT, Day 42 and Day 84, as determined by the DRC |
| Secondary | Percentage of Participants With a Clinical, Mycological and Radiological Response. | End of Treatment (EoT), Day 42 and Day 84 | Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Mycological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Radiological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator |
| Secondary | SCY-078 and Voriconazole Plasma Concentrations | Treatment Days 7 and 14 (2-4 hrs post dose) | Voriconazole and SCY-078 plasma concentrations (ng/mL) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | Up to a maximum of 19 weeks | Safety population including any participant treated with at least one dose of Voriconazole or SCY-078 | participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC) | At end of treatment (up to 13 weeks), day 42 and day 84 | Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Died (Any Cause) | At Day 42 and Day 84 | Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Serum Galactomannan Index (GMI) | Weeks 1, 2, 4 and 6 | Participants who have a probable or proven invasive pulmonary aspergillosis at baseline, per DRC, with at least one positive serum GMI at baseline and at least one GMI value at Weeks 1, 2, 4 and/or 6. | index | MEAN |
| SECONDARY | Percent of Participants With Changes in GMI | Weeks 1, 2, 4 and 6 from Baseline | Modified Intent-to-treat (mITT) population including participants who have a probable or proven invasive pulmonary aspergillosis at baseline, per DRC, with at least one positive serum GMI at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Achieve Serum GMI Change From Baseline | Up to a maximum of 19 weeks | Intent-to-treat (ITT) population including participants who have a probable or proven invasive pulmonary aspergillosis at baseline, per DRC. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC | End of Treatment (EoT), Day 42 and Day 84 | Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With a Clinical, Mycological and Radiological Response. | End of Treatment (EoT), Day 42 and Day 84 | Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | SCY-078 and Voriconazole Plasma Concentrations | Treatment Days 7 and 14 (2-4 hrs post dose) | Participants of study who provide a PK sample | nanograms per milliliter (ng/mL) | MEAN |
Source ClinicalTrials.gov
Results by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | SCY-078 Plus Voriconazole | Number of participants with treatment emergent adverse events | 10 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | Voriconazole Mono-therapy | Number of participants with treatment emergent adverse events | 11 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | SCY-078 Plus Voriconazole | Number of participants with treatment-related adverse events | 4 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | Voriconazole Mono-therapy | Number of participants with treatment-related adverse events | 0 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | SCY-078 Plus Voriconazole | Number of participants discontinued due to adverse event | 2 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | Voriconazole Mono-therapy | Number of participants discontinued due to adverse event | 4 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | SCY-078 Plus Voriconazole | Number of participants who died | 3 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths | Voriconazole Mono-therapy | Number of participants who died | 1 | participants | |
| Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC) | SCY-078 Plus Voriconazole | Participants with Complete or Partial Response at End of Treatment | 7 | Participants | |
| Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC) | Voriconazole Mono-therapy | Participants with Complete or Partial Response at End of Treatment | 9 | Participants |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SCY-078 Plus Voriconazole | 10 | |
| Overall Study | STARTED | Voriconazole Mono-therapy | 12 | |
| Overall Study | COMPLETED | SCY-078 Plus Voriconazole | 6 | |
| Overall Study | COMPLETED | Voriconazole Mono-therapy | 8 | |
| Overall Study | NOT COMPLETED | SCY-078 Plus Voriconazole | 4 | |
| Overall Study | NOT COMPLETED | Voriconazole Mono-therapy | 4 |
Source ClinicalTrials.gov
Adverse events300
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | SCY-078 Plus Voriconazole | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Voriconazole Mono-therapy | 0 | 12 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | SCY-078 Plus Voriconazole | 2 | 10 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Voriconazole Mono-therapy | 0 | 12 | |
| other | Haemolysis | Blood and lymphatic system disorders | SCY-078 Plus Voriconazole | 1 | 10 | |
| other | Haemolysis | Blood and lymphatic system disorders | Voriconazole Mono-therapy | 0 | 12 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | SCY-078 Plus Voriconazole | 0 | 10 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Voriconazole Mono-therapy | 1 | 12 | |
| other | Neutropenia | Blood and lymphatic system disorders | SCY-078 Plus Voriconazole | 1 | 10 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole Mono-therapy | 0 | 12 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SCY-078 Plus Voriconazole | 3 | 10 |
| Total, all-cause mortality | Voriconazole Mono-therapy | 1 | 12 |
| Total, other adverse events | SCY-078 Plus Voriconazole | 10 | 10 |
| Total, other adverse events | Voriconazole Mono-therapy | 11 | 12 |
| Total, serious adverse events | SCY-078 Plus Voriconazole | 6 | 10 |
| Total, serious adverse events | Voriconazole Mono-therapy | 5 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SCY-078 Plus Voriconazole vs Voriconazole Mono-therapy: deaths from any cause | Trial comparisons |
| SCY-078 Plus Voriconazole vs Voriconazole Mono-therapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03672292
GET https://conductscience.org/api/trials/v1/NCT03672292/results?page=2