An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 入组人数
- 125
- 试验地点
- 86
- 主要终点
- Long-term safety of relacorilant
研究概览
简要总结
This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.
详细描述
This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.
Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Inclusion Criteria:
- •Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome
- •According to the Investigator's opinion will benefit from continuing treatment with relacorilant.
排除标准
- •Major Exclusion Criteria:
- •Premature discontinuation from a relacorilant parent study
- •Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
研究组 & 干预措施
relacorilant (CORT125134)
干预措施: relacorilant (Drug)
结局指标
主要结局
Long-term safety of relacorilant
时间窗: 36 months
Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher
次要结局
未报告次要终点
