Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi

NCT07804368 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00027252, NB600395
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Coccidioidomycosis; Blastomycosis; Histoplasmosis; Dimorphic Fungal Infection; Endemic Mycoses

Keywords

Dimorphic fungi; Endemic mycoses; Salvage therapy; Coccidioidomycosis; Antifungal therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline through 12 months

Secondary Outcomes (7)

• Serious Adverse Event Rate

  Through 1 year

• Discontinuation of Study Drug Due to Therapeutic Failure

  Through study drug treatment period, up to 12 months

• Discontinuation of Study Drug Due to Adverse Events

  Through study drug treatment period, up to 12 months

• Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance

  Through study drug treatment period, up to 12 months

• Incidence of Laboratory Adverse Events

  Through study drug treatment period, up to 12 months

Study Arms (1)

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.

Drug: Oteseconazole

Interventions

Oteseconazole DRUG

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

Oteseconazole Salvage or Consolidation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Children
• Pregnant women/persons
• Fetuses
• Neonates
• Prisoners
• Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent

Sponsors & Collaborators

• University of Minnesota: lead
• Centers for Disease Control and Prevention: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (4)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Arizona State University - Tempe Campus

Tempe, Arizona, 85287, United States

Location

University of California, Davis

Davis, California, 95616, United States

Location

UCSF Fresno

Fresno, California, 93701-2302, United States

Location

MeSH Terms

Conditions

Coccidioidomycosis; Blastomycosis; Histoplasmosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Dermatomycoses; Lung Diseases, Fungal; Respiratory Tract Infections; Skin Diseases, Infectious; Lung Diseases; Respiratory Tract Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Matthew Pullen, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Pullen, MD

CONTACT

615-504-2172; pullen@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-08

Locations

US (4)