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A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM ) Treated With Olorofim Plus Baseline SOC or Placebo Plus Baseline SOC

NCT07712484 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-17

No results posted yet for this study

Summary

The purpose of this study is to test measurement tools (questionnaire about symptoms and a questionnaire about quality of life) to assess usability in the assessment of treatment effectiveness for people with disseminated coccidioidomycosis (DCM).

Conditions

  • Coccidioidomycosis
  • Disseminated Fungal Infection
  • Coccidioides Infection
  • Coccidioides Immitis Infection
  • Coccidioides Posadasii Infection
  • Coccidioidomycosis Infection
  • San Joaquin Valley Fever
  • Valley Fever

Interventions

DRUG

Olorofim

Arm A: Oral olorofim loading dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 followed by a maintenance dose of 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 168 (± 7 days)

DRUG

Placebo

Arm B: Oral olorofim-matched placebo loading dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 followed by a maintenance dose of 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 168 (± 7 days)

Sponsors & Collaborators

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • F2G Ltd

    lead INDUSTRY

Principal Investigators

  • George R. Thompson, MD · University of California, Davis, School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-06-30
Completion
2028-07-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712484 on ClinicalTrials.gov