CoccidioidomycosisPhase 2COCCIMETRICSNCT07712484
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care
A Phase 2 study testing Olorofim in people with Coccidioidomycosis and Disseminated Fungal Infection, run by F2G Ltd.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccidioidomycosis, Disseminated Fungal Infection, Coccidioides Infection
- What is being tested?
- Olorofim
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Evidence of hepatic dysfunction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COCCIMETRICS: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM) Treated With Olorofim Plus Baseline Standard of Care (SOC) or With Placebo Plus Baseline SOC
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).
Read the detailed description
Valley Fever (coccidioidomycosis) is a serious fungal infection that can cause long-lasting symptoms.
Currently marketed antifungal drugs have limitations including limited dosage forms, drug-drug interactions (DDIs), and significant adverse reactions.
Olorofim is an antifungal candidate with a novel mechanism of action offering activity against resistant organisms, differences in safety profile, along with oral route of administration, predictable and reliable pharmacokinetic (PK) profile and limited potential for DDIs.
This study tests whether the Valley Fever-Patient Reported Outcome (VF-PRO) questionnaire can reliably measure symptom impacts and changes over time in patients with severe forms of the disease (disseminated coccidioidomycosis (DCM)). The study will also assess symptoms of DCM and their severity, and whether olorofim, is safe and can help people with DCM when given together with standard antifungal medications (also known as standard-of-care or SOC).
- Conditions
- Coccidioidomycosis, Disseminated Fungal Infection, Coccidioides Infection, Coccidioides Immitis Infection, Coccidioides Posadasii Infection, Coccidioidomycosis Infection
- Being tested
- Olorofim, Placebo
- 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
- Medical subject headings
- Coccidioidomycosis, Invasive Fungal Infections, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlorofimDrug
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)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm A (olorofim, plus Standard of Care) | Active comparator | Arm A: receives oral olorofim + Standard of Care Receives: Drug: Olorofim |
| Arm B (placebo comparator, plus Standard of Care) | Placebo comparator | Arm B: receives olorofim-matched placebo + Standard of Care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Valley Fever - Patient Reported Outcomes (VF-PRO) Mobility domain score
Change from baseline in VF-PRO Mobility domain score at the Day 168 (Week 24) study visit. Minimum score: Cannot Do; Maximum score: Not at all difficult. Higher score means more able to do the activities related to Mobility.
Measured: Day 168
Change from baseline in Valley Fever - Patient Reported Outcomes (VF-PRO) Daily Function domain score
Change from baseline in VF-PRO Daily Function domain score at the Day 168 (Week 24) study visit. Minimum score: Cannot Do; Maximum score: Not at all difficult. Higher score means more able to do the activities related to Daily Function.
Measured: Day 168
Secondary outcomes (3)
% of patients with a reduction in severity of at least one of their most bothersome baseline DCM-related symptoms
% of patients with a reduction in severity of at least one of their most bothersome baseline DCM-related symptoms, and no worsening of their other most bothersome baseline DCM-related symptoms, at the Day 28, Day 56, Day 84, Day 112, Day 140 and Day 168 (Weeks 4, 8, 12, 16, 20 and 24) study visits.
Measured: Day 28, Day 56, Day 84, Day 112, Day 140, Day 168
To monitor incidence of Adverse Events in both treatment arms
Measured: up to the Day 168 study visit and 4-week Follow-up (FU)
To monitor incidence of Serious Adverse Events in both treatment arms.
Measured: up to the Day 168 study visit and 4-week Follow-up (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Responsible party
- Sponsor
- Investigators
- George R. Thompson, MD, Principal investigator, University of California, Davis, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712484
- Sponsor's protocol ID
- F901318/0037
- Acronym
- COCCIMETRICS
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COCCIMETRICS: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM) Treated With Olorofim Plus Baseline Standard of Care (SOC) or With Placebo Plus Baseline SOC
- ClinicalTrials.gov ID
- NCT07712484
- Acronym / sponsor ID
- COCCIMETRICS / F901318/0037
- Conditions
- Coccidioidomycosis, Disseminated Fungal Infection, Coccidioides Infection, Coccidioides Immitis Infection, Coccidioides Posadasii Infection, Coccidioidomycosis Infection
- Keywords
- Cocci, Coccidioidomycosis, Disseminated coccidioidomycosis, Olorofim, Valley Fever, Patient-reported outcomes, Valley Fever Patient Reported Outcome, Symptom assessment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Valley Fever (coccidioidomycosis) is a serious fungal infection that can cause long-lasting symptoms.
Currently marketed antifungal drugs have limitations including limited dosage forms, drug-drug interactions (DDIs), and significant adverse reactions.
Olorofim is an antifungal candidate with a novel mechanism of action offering activity against resistant organisms, differences in safety profile, along with oral route of administration, predictable and reliable pharmacokinetic (PK) profile and limited potential for DDIs.
This study tests whether the Valley Fever-Patient Reported Outcome (VF-PRO) questionnaire can reliably measure symptom impacts and changes over time in patients with severe forms of the disease (disseminated coccidioidomycosis (DCM)). The study will also assess symptoms of DCM and their severity, and whether olorofim, is safe and can help people with DCM when given together with standard antifungal medications (also known as standard-of-care or SOC).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (olorofim, plus Standard of Care) | Active comparator | Drug: OlorofimArm A: receives oral olorofim + Standard of Care |
| Arm B (placebo comparator, plus Standard of Care) | Placebo comparator | Drug: PlaceboArm B: receives olorofim-matched placebo + Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlorofimArm 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 | Arm A (olorofim, plus Standard of Care) |
| PlaceboArm 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) | Drug | Arm B (placebo comparator, plus Standard of Care) |
Primary outcome
Change from baseline in Valley Fever - Patient Reported Outcomes (VF-PRO) Mobility domain score
Time frame: Day 168
Change from baseline in VF-PRO Mobility domain score at the Day 168 (Week 24) study visit. Minimum score: Cannot Do; Maximum score: Not at all difficult. Higher score means more able to do the activities related to Mobility.
Change from baseline in Valley Fever - Patient Reported Outcomes (VF-PRO) Daily Function domain score
Time frame: Day 168
Change from baseline in VF-PRO Daily Function domain score at the Day 168 (Week 24) study visit. Minimum score: Cannot Do; Maximum score: Not at all difficult. Higher score means more able to do the activities related to Daily Function.
3 secondary outcomes
% of patients with a reduction in severity of at least one of their most bothersome baseline DCM-related symptoms
Time frame: Day 28, Day 56, Day 84, Day 112, Day 140, Day 168
To monitor incidence of Adverse Events in both treatment arms
Time frame: up to the Day 168 study visit and 4-week Follow-up (FU)
To monitor incidence of Serious Adverse Events in both treatment arms.
Time frame: up to the Day 168 study visit and 4-week Follow-up (FU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Coccidioidomycosis
RecruitingObservational study
Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
Coccidioidomycosis
RecruitingObservational study
RVF and Other Emerging Infectious Diseases in East and Central Africa
Rift Valley Fever, Hemorrhagic Fevers, Viral
Not yet recruitingPhase 3
Nitazoxanide for Treatment of Cryptosporidium in Children
Cryptosporidiosis
Not yet recruitingPhase 2
Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
Coccidioidomycosis, Blastomycosis
RecruitingPhase 2
Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
Cryptosporidiosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George R. Thompson, MD principal investigator
University of California, Davis, School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olorofim in people with Coccidioidomycosis and Disseminated Fungal Infection, run by F2G Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Wardman (+44 (0)161 518 0401, awardman@f2g.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Valley Fever - Patient Reported Outcomes (VF-PRO) Mobility domain score (time frame: Day 168). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.