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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

ConditionsCoccidioidomycosisDisseminated Fungal InfectionCoccidioides InfectionCoccidioides Immitis InfectionCoccidioides Posadasii InfectionCoccidioidomycosis InfectionSan Joaquin Valley FeverValley Fever
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorF2G Ltd

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm A (olorofim, plus Standard of Care)Active comparator 1 intervention
Group B: Arm B (placebo comparator, plus Standard of Care)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 168
2

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.

Time frame
Day 168

Secondary outcomes

1

% 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.

Time frame
Day 28, Day 56, Day 84, Day 112, Day 140, Day 168
2

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)
3

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

F2G Ltd

Lead sponsor

IQVIA RDS Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: