Olorofim for Valley Fever

Overseen By Jose Elizondo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Fariba Donovan

Must not be taking: Cannabis, Teriflunomide, Leflunomide, others

Disqualifiers: Pregnancy, HIV without ART, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This research study is being conducted to learn more about the use of olorofim in Coccidioidal (Cocci) meningitis, a rare but serious fungal infection that affects the brain and spinal cord. The study is exploratory, meaning that early information is being gathered to better understand the effectiveness of olorofim in coccidioidal meningitis in its early stages. The study plans to enroll approximately 10 to 12 participants who have been recently diagnosed-within the last 4 to 8 weeks-and who do not have a ventriculoperitoneal (VP) shunt, a medical device sometimes used to relieve pressure in the brain. Participants will be followed for approximately 6 months, during which health information will be collected to evaluate disease progression and response to treatment. Participants may have the opportunity to enroll in the olorofim Managed Access Program to continue treatment after completion of the study period.

Who Is on the Research Team?

Fariba Donovan, MD, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for individuals recently diagnosed with Coccidioidal meningitis, a brain and spinal cord infection caused by a fungus. Participants must have been diagnosed within the last 8 weeks, be able to give consent, and not have a VP shunt. Women of childbearing potential must use effective birth control during the study.

Inclusion Criteria

I have undergone a procedure for male sterilization.

a) who have given voluntary written informed consent, or whose legally authorized representative(s) has been fully informed and has given voluntary written informed consent if applicable, and in compliance with local regulations OR 2. b) who have given oral informed consent witnessed in writing by an independent person and in compliance with local regulations for patients who are unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative).

I was diagnosed with fungal meningitis less than 8 weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with olorofim for coccidioidal meningitis

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into the olorofim Managed Access Program to continue treatment after completion of the study period

What Are the Treatments Tested in This Trial?

Interventions

• Olorofim

Trial Overview

The trial is testing olorofim's effectiveness in treating early-stage Coccidioidal meningitis. About 10-12 participants will be monitored over six months to see how well they respond to the treatment. There's also an option to continue receiving olorofim after the study ends.

How Is the Trial Designed?

Group I: olorofim Experimental Treatment 1 Intervention

Participants will receive treatment with olorofim

Who Is Running the Clinical Trial?

Fariba Donovan

Lead Sponsor

F2G Biotech GmbH

Industry Sponsor

Trials

21

Recruited

1,800+