An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants With Severe Eosinophilic Asthma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 509
- 试验地点
- 98
- 主要终点
- Number and Percentage of Participants with a Treatment Emergent Adverse Event
研究概览
简要总结
The goal of this clinical trial] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 [GINA, 2021] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.
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
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-
- •Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day
- •WOCBP (after menarche) must use either of the following methods of birth control, from the Baseline Visit/Day 1 through the End of Study Visit:
- •A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system, levonorgestrel intrauterine system, or oral contraceptive. -OR-
- •Two protocol acceptable methods of contraception in tandem. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the Baseline Visit/Day 1 without an alternative medical cause. The following age specific requirements apply:
- •Women <50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range.
- •Women ≥50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
排除标准
- •Clinically significant change in health status during either of the Phase III studies EXHALE-2 or EXHALE-3 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
- •Participants with allergy/intolerance to dexpramipexole or any of its excipients.
- •Participants who met permanent discontinuation criteria or permanently discontinued study treatment for any reason in either of the Phase III studies EXHALE-2 or EXHALE-3..
- •Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days.
- •Pregnant or breastfeeding women.
- •Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
研究组 & 干预措施
150 mg BID
Dexpramipexole 150 mg oral tablet taken twice a day.
干预措施: Dexpramipexole Dihydrochloride (Drug)
结局指标
主要结局
Number and Percentage of Participants with a Treatment Emergent Adverse Event
时间窗: 52 weeks
Summary of participants from the safety population who experienced an adverse event.
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations
时间窗: 52 weeks
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in hematology and chemistry results.
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight
时间窗: 52 weeks
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in vital signs (blood pressure, pulse rate, respiratory rate, and temperature) or body weight.
Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters
时间窗: 52 weeks
Summary of participants from the safety population who experienced potentially significant postbaseline changes in electrocardiogram parameters: heart rate, PR, QRS and QTcF intervals.
次要结局
- Severe Asthma Exacerbations(Averaged across 52 weeks)
- Change in Asthma Control Questionnaire-6 (ACQ-6)(Day 1 (baseline), Weeks 16, 32, and 52)
- Change in absolute eosinophil counts (AEC)(Day 1 (baseline), Weeks 16, 32, and 52)