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 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: F901318/0037
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cocci; Coccidioidomycosis; Disseminated coccidioidomycosis; Olorofim; Valley Fever; Patient-reported outcomes; Valley Fever Patient Reported Outcome; Symptom assessment; Endpoint development; Outcome measure validation; Quality of life; Fungal infection; Invasive fungal disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline in VF-PRO Mobility domain score

  Change from baseline in VF-PRO Mobility domain score at the Day 168 (Week 24) study visit.

  Day 168

• Change from baseline in VF-PRO Daily Function domain score

  Change from baseline in VF-PRO Daily Function domain score at the Day 168 (Week 24) study visit.

  Day 168

Secondary Outcomes (3)

• % of patients with a reduction in severity of at least one of their most bothersome baseline DCM-related symptoms

  Day 28, Day 56, Day 84, Day 112, Day 140, Day 168

• To monitor incidence of Adverse Events in both treatment arms

  up to the Day 168 study visit and 4-week Follow-up (FU)

• To monitor incidence of Serious Adverse Events in both treatment arms.

  up to the Day 168 study visit and 4-week Follow-up (FU)

Study Arms (2)

Arm A (olorofim, plus Standard of Care)

ACTIVE COMPARATOR

Arm A: receives oral olorofim + Standard of Care

Drug: Olorofim

Arm B (placebo comparator, plus Standard of Care)

PLACEBO COMPARATOR

Arm B: receives olorofim-matched placebo + Standard of Care

Drug: Placebo

Interventions

Olorofim DRUG

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)

Arm A (olorofim, plus Standard of Care)

Placebo DRUG

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)

Arm B (placebo comparator, plus Standard of Care)

Eligibility Criteria

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

You may qualify if:

• Male and female patients, English- or Spanish-speaking, aged ≥18 years and weighing ≥40 kg.
• Patients with progressive or refractory disseminated coccidioidomycosis (DCM) involving extra-pulmonary sites with or without ongoing active disease in lungs.
• Standard of Care therapy for DCM to date has included 2 different triazoles (with or without a course of intravenous amphotericin B).

You may not qualify if:

• Patients who are unconscious.
• Women who are pregnant or breastfeeding.
• Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
• Patients with or planned placement of indwelling CNS devices.
• Patients receiving intrathecal amphotericin B at the time of study enrolment.
• Coccidioidomycosis limited to fibro-cavitary pulmonary disease.
• All bothersome DCM-related symptoms at study entry are due to irreversible damage (e.g., neurologic deficits due to stroke).
• Other than cutaneous fungal infections treated topically and Pneumocystis jirovecii infections, patients with a second fungal infection requiring systemic antifungal treatment or prophylaxis.
• Patients with microbiological findings or other potential conditions that are temporally related and suggest a different than study indication etiology for the clinical features.
• Patients living with Human immunodeficiency virus (HIV) unless for at least 6 months prior to enrollment:
• Are receiving antiretroviral therapy AND
• Have no evidence of current clinical progression resulting from HIV infection.
• Patients who have received prior treatment with olorofim/F901318.
• Patients receiving treatment limited to supportive care due to predicted short survival time.
• Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥500 msec, or at high risk for QT/QTc prolongation.

Sponsors & Collaborators

• F2G Ltd: lead
• IQVIA RDS Inc.: collaborator

MeSH Terms

Conditions

Coccidioidomycosis; Invasive Fungal Infections; Mycoses

Interventions

olorofim

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• George R. Thompson, MD

  University of California, Davis, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Wardman

CONTACT

+44 (0)161 518 0401; awardman@f2g.com

Julia Vassiliadou

CONTACT

+44 (0)7557 290308; Julia.Vassiliadou@f2g.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07