New drug and better measurement tools aim to tackle severe valley fever
NCT ID NCT07712484
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This phase 2 trial tests an experimental antifungal drug called olorofim in people with a severe, body-wide form of Valley Fever (disseminated coccidioidomycosis) that has not responded to standard treatments. The study also evaluates new questionnaires about symptoms and quality of life to see if they are useful for measuring how well treatments work. Participants receive either olorofim or a placebo, both added to their usual care, for 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antifungal drug called olorofim
- What this could lead to
- If successful, this trial could help establish better ways to measure treatment effectiveness for disseminated Valley Fever, potentially leading to improved therapies.
- What could go wrong
- This is a small, early-phase trial focused on testing measurement tools, not on proving the drug works. The drug may not show clear benefit, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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: 1. Are receiving antiretroviral therapy AND 2. 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. * Evidence of hepatic dysfunction.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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