A Phase 2 interventional study of Oteseconazole in Coccidioidomycosis, Blastomycosis and Histoplasmosis, sponsored by University of Minnesota. Not yet recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment
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.
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.
21 studies on the registry are indexed under Coccidioidomycosis; 4 are open to participants now.
This study's planned enrollment of 30 is below the median of 48 across 13 interventional studies indexed under Coccidioidomycosis.
Browse Coccidioidomycosis studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Oteseconazole
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.
Also known as: VIVJOA
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.
Time frame: 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.
Time frame: Baseline through 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 12 months
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
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Studies of the drug tested here: VT-1161