CoccidioidomycosisPhase 2NCT07804368
Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
A Phase 2 study testing Oteseconazole in people with Coccidioidomycosis and Blastomycosis, run by University of Minnesota at 4 sites in United States.
Trial summary
This Phase II platform trial will evaluate the safety, tolerability, and effectiveness of investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccidioidomycosis, Blastomycosis, Histoplasmosis
- What is being tested?
- Oteseconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of coccidioidomycosis, blastomycosis, or histoplasmosis and on active therapy
- Age 18 years or older
- Anticipated need for at least 6 additional months of antifungal therapy at enrollment
- Intolerance, failure, or unavailability of current first-line consolidation therapy
Who cannot join
- Currently hospitalized
- Central nervous system involvement of coccidioidomycosis, blastomycosis, or histoplasmosis
- Previous administration of or allergy to study drug
- Any condition for which participation would not be in the best interest of the participant or that could limit protocol-specified assessments
- Females of childbearing potential
- Breast Cancer Resistance Protein substrate medication interaction that cannot be managed by switching medication, discontinuation, 50% dose reduction, or use of the lowest dose
Show all 12Show fewer
- Children
- Pregnant women/persons
- Fetuses
- Neonates
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
University of California, Davis
Davis, California, 95616
Matthew Pullen, MD, 615-504-2172, Pullen@umn.edu
UCSF Fresno
Fresno, California, 93701-2302
Matthew Pullen, MD, 615-504-2172, Pullen@umn.edu
Mayo Clinic
Phoenix, Arizona, 85054
Matthew Pullen, MD, 615-504-2172, Pullen@umn.edu
Arizona State University - Tempe Campus
Tempe, Arizona, 85287
About this study
This Phase II platform trial will evaluate the safety, tolerability, and effectiveness of investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis.
The study will enroll adults who are receiving active antifungal therapy and who have intolerance, failure, or unavailability of standard first-line consolidation therapy. The first investigational agent evaluated in the platform trial is oteseconazole.
Participants will receive study drug and complete follow-up assessments for symptom status, functional status, adverse events, laboratory safety, study drug discontinuation, and quality of life. Participants will be followed during therapy and for up to 6 months after therapy.
Read the detailed description
Dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis, are commonly treated with azole antifungals such as itraconazole or fluconazole as consolidation therapy. However, some patients experience intolerance, treatment failure, drug interactions, toxicity, or lack of access to standard first-line consolidation therapy. For these patients, treatment options are limited.
This study is an open-label, single-arm Phase II platform trial designed to evaluate investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections. The first investigational agent evaluated in this platform is oteseconazole.
Eligible participants will be adults with coccidioidomycosis, blastomycosis, or histoplasmosis who are on active therapy, are expected to require at least 6 additional months of antifungal therapy, and have intolerance, failure, or unavailability of current first-line consolidation therapy. Participants will complete screening and informed consent through REDCap. Study drug will be mailed to participants by the central pharmacy after enrollment.
Participants will complete monthly follow-up surveys assessing symptom status, functional status, quality of life, antifungal therapy changes, and treatment tolerance. Safety monitoring will include adverse event tracking, serious adverse event reporting, and laboratory assessments. Participants will be followed for up to 18 months, including the treatment period and 6 months of post-therapy follow-up.
- Conditions
- Coccidioidomycosis, Blastomycosis, Histoplasmosis, Dimorphic Fungal Infection, Endemic Mycoses
- Being tested
- Oteseconazole
- Keywords
- Dimorphic fungi, Endemic mycoses, Salvage therapy, Coccidioidomycosis, Antifungal therapy
- Medical subject headings
- Coccidioidomycosis, Blastomycosis, Histoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OteseconazoleDrug
Also called VIVJOA
Participants will receive oral oteseconazole 600 mg twice daily for 12 days, followed by 600 mg weekly. Total treatment duration depends on diagnosis: up to 52 weeks for coccidioidomycosis, 26 weeks for blastomycosis, and 26 weeks for histoplasmosis.
| Study group | Role | What they receive |
|---|---|---|
| Oteseconazole Salvage or Consolidation Therapy | Experimental | Participants will receive oteseconazole as salvage or consolidation therapy for dimorphic fungal infection after intolerance, failure, or unavailability of standard first-line consolidation therapy. Participants will be followed for safety, tolerability, symptom status, functional status, adverse events, and treatment discontinuation. Receives: Drug: Oteseconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Status
Symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Measured: Baseline through 12 months
Change in Functional Status
Functional status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Measured: Baseline through 12 months
Secondary outcomes (7)
Serious Adverse Event Rate
Serious adverse event rate will be assessed through 1 year, including events such as death, all-cause re-hospitalization, permanent neurologic deficit, and other serious adverse events.
Measured: Through 1 year
Discontinuation of Study Drug Due to Therapeutic Failure
The number of participants who discontinue study drug due to therapeutic failure with worsening clinical symptoms will be assessed.
Measured: Through study drug treatment period, up to 12 months
Discontinuation of Study Drug Due to Adverse Events
The number of participants who discontinue study drug due to adverse events will be assessed.
Measured: Through study drug treatment period, up to 12 months
Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance
The incidence of study drug discontinuation, dose reduction, or interruption due to toxicity or intolerance will be assessed by grade.
Measured: Through study drug treatment period, up to 12 months
Incidence of Laboratory Adverse Events
Laboratory adverse events will be assessed with focus on alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and direct, indirect, and total bilirubin, using the NIH DAIDS Adverse Event Grading document.
Measured: Through study drug treatment period, up to 12 months
Change in PROMIS-29 Scores
PROMIS-29 scores will be assessed over time to evaluate changes in patient-reported health status and quality of life.
Measured: Baseline through study follow-up, up to 18 months
Change in Fatigue Symptom Status
Fatigue symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single-arm Phase II platform trial evaluating investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis, who are intolerant of, have failed, or cannot access standard first-line consolidation therapy. The first investigational agent evaluated in the platform is oteseconazole.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Matthew Pullen, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804368
- Sponsor's protocol ID
- STUDY00027252, NB600395
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
- ClinicalTrials.gov ID
- NCT07804368
- Acronym / sponsor ID
- STUDY00027252, NB600395
- Conditions
- Coccidioidomycosis, Blastomycosis, Histoplasmosis, Dimorphic Fungal Infection, Endemic Mycoses
- Keywords
- Dimorphic fungi, Endemic mycoses, Salvage therapy, Coccidioidomycosis, Antifungal therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Alabama at Birmingham
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II platform trial will evaluate the safety, tolerability, and effectiveness of investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis.
The study will enroll adults who are receiving active antifungal therapy and who have intolerance, failure, or unavailability of standard first-line consolidation therapy. The first investigational agent evaluated in the platform trial is oteseconazole.
Participants will receive study drug and complete follow-up assessments for symptom status, functional status, adverse events, laboratory safety, study drug discontinuation, and quality of life. Participants will be followed during therapy and for up to 6 months after therapy.
Detailed description
Dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis, are commonly treated with azole antifungals such as itraconazole or fluconazole as consolidation therapy. However, some patients experience intolerance, treatment failure, drug interactions, toxicity, or lack of access to standard first-line consolidation therapy. For these patients, treatment options are limited.
This study is an open-label, single-arm Phase II platform trial designed to evaluate investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections. The first investigational agent evaluated in this platform is oteseconazole.
Eligible participants will be adults with coccidioidomycosis, blastomycosis, or histoplasmosis who are on active therapy, are expected to require at least 6 additional months of antifungal therapy, and have intolerance, failure, or unavailability of current first-line consolidation therapy. Participants will complete screening and informed consent through REDCap. Study drug will be mailed to participants by the central pharmacy after enrollment.
Participants will complete monthly follow-up surveys assessing symptom status, functional status, quality of life, antifungal therapy changes, and treatment tolerance. Safety monitoring will include adverse event tracking, serious adverse event reporting, and laboratory assessments. Participants will be followed for up to 18 months, including the treatment period and 6 months of post-therapy follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-arm Phase II platform trial evaluating investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis, who are intolerant of, have failed, or cannot access standard first-line consolidation therapy. The first investigational agent evaluated in the platform is oteseconazole.
| Arm | Type | Receives |
|---|---|---|
| Oteseconazole Salvage or Consolidation Therapy | Experimental | Drug: OteseconazoleParticipants will receive oteseconazole as salvage or consolidation therapy for dimorphic fungal infection after intolerance, failure, or unavailability of standard first-line consolidation therapy. Participants will be followed for safety, tolerability, symptom status, functional status, adverse events, and treatment discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of coccidioidomycosis, blastomycosis, or histoplasmosis and on active therapy
- Age 18 years or older
- Anticipated need for at least 6 additional months of antifungal therapy at enrollment
- Intolerance, failure, or unavailability of current first-line consolidation therapy
Key exclusion criteria (12 listed)
- Currently hospitalized
- Central nervous system involvement of coccidioidomycosis, blastomycosis, or histoplasmosis
- Previous administration of or allergy to study drug
- Any condition for which participation would not be in the best interest of the participant or that could limit protocol-specified assessments
- Females of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OteseconazoleAlso: VIVJOAParticipants will receive oral oteseconazole 600 mg twice daily for 12 days, followed by 600 mg weekly. Total treatment duration depends on diagnosis: up to 52 weeks for coccidioidomycosis, 26 weeks for blastomycosis, and 26 weeks for histoplasmosis. | Drug | Oteseconazole Salvage or Consolidation Therapy |
Primary outcome
Change in Symptom Status
Time frame: Baseline through 12 months
Symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Change in Functional Status
Time frame: Baseline through 12 months
Functional status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
7 secondary outcomes
Serious Adverse Event Rate
Time frame: Through 1 year
Discontinuation of Study Drug Due to Therapeutic Failure
Time frame: Through study drug treatment period, up to 12 months
Discontinuation of Study Drug Due to Adverse Events
Time frame: Through study drug treatment period, up to 12 months
Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance
Time frame: Through study drug treatment period, up to 12 months
Incidence of Laboratory Adverse Events
Time frame: Through study drug treatment period, up to 12 months
Change in PROMIS-29 Scores
Time frame: Baseline through study follow-up, up to 18 months
Change in Fatigue Symptom Status
Time frame: Baseline through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Pullen, MD principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oteseconazole in people with Coccidioidomycosis and Blastomycosis, run by University of Minnesota at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Pullen, MD (615-504-2172, pullen@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Status (time frame: Baseline through 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.