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 (COCCIMETRICS)
2026年7月14日 更新者：F2G Ltd
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).
研究概览
地位
尚未招聘
条件
干预/治疗
详细说明
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).
研究类型
介入性
注册 (估计的)
50
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Angela Wardman
- 电话号码：+44 (0)161 518 0401
- 邮箱：awardman@f2g.com
研究联系人备份
- 姓名：Julia Vassiliadou
- 电话号码：+44 (0)7557 290308
- 邮箱：Julia.Vassiliadou@f2g.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm A (olorofim, plus Standard of Care)
Arm A: receives oral olorofim + Standard of Care
|
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)
|
|
安慰剂比较：Arm B (placebo comparator, plus Standard of Care)
Arm B: receives olorofim-matched placebo + Standard of Care
|
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)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in VF-PRO Mobility domain score
大体时间：Day 168
|
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
大体时间：Day 168
|
Change from baseline in VF-PRO Daily Function domain score at the Day 168 (Week 24) study visit.
|
Day 168
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
% of patients with a reduction in severity of at least one of their most bothersome baseline DCM-related symptoms
大体时间：Day 28, Day 56, Day 84, Day 112, Day 140, Day 168
|
% 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.
|
Day 28, Day 56, Day 84, Day 112, Day 140, Day 168
|
|
To monitor incidence of Adverse Events in both treatment arms
大体时间：up to the Day 168 study visit and 4-week Follow-up (FU)
|
up to the Day 168 study visit and 4-week Follow-up (FU)
|
|
|
To monitor incidence of Serious Adverse Events in both treatment arms.
大体时间：up to the Day 168 study visit and 4-week Follow-up (FU)
|
up to the Day 168 study visit and 4-week Follow-up (FU)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
合作者
调查人员
- 首席研究员：George R. Thompson, MD、University of California, Davis, School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月1日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年7月1日
研究注册日期
首次提交
2026年7月14日
首先提交符合 QC 标准的
2026年7月14日
首次发布 (实际的)
2026年7月17日
研究记录更新
最后更新发布 (实际的)
2026年7月17日
上次提交的符合 QC 标准的更新
2026年7月14日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- F901318/0037
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.