A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 5
- 主要终点
- Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of HMI-115 compared to placebo over a 12 weeks period on subjects with moderate to severe endometriosis-associated pain.
详细描述
This study aims to evaluate the safety and efficacy of HMI-115 versus a placebo in pre-menopausal women with moderate to severe Endometriosis associated pain.
The study will determine the safety and efficacy of HMI 115 at 3 dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
- •Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
- •Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 with a score of at least 2 for DYS and at least 2 for NMPP at screening.
- •Subject agrees not to participate in another interventional study while participating in the present study.
排除标准
- •Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
- •Subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain
- •Subject has clinically significant gynecologic condition other than endometriosis
- •Subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti inflammatory drugs (NSAIDS) or any contraindication to their use such as gastrointestinal ulcer or bleeding
- •Subject has history of hysterectomy and/or bilateral oophorectomy
- •Subjects with past or present pituitary tumor growth
- •Subjects has a history of osteoporosis or other metabolic bone disease
研究组 & 干预措施
HMI-115 60mg
Once Every 2 weeks, subcutaneously injection
干预措施: HMI-115 (Drug)
HMI-115 120mg
Once Every 2 weeks, subcutaneously injection
干预措施: HMI-115 (Drug)
HMI-115 240mg
Once Every 2 weeks, subcutaneously injection
干预措施: HMI-115 (Drug)
Placebo
Once Every 2 weeks, subcutaneously injection
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)
时间窗: Baseline, Week 12
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change）
时间窗: Baseline, Week 12
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
次要结局
- Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)(Baseline, Week 24)
- Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change)(Baseline, week 12 and 24)
- Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP(Baseline, week 12 and 24)
- Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use(Baseline, week 12 and 24)
- Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change)(Baseline, week 12 and 24)
- Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit(Baseline, week 12 and 24)
- Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change)(Baseline, Week 24)
- Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change)(Baseline, Week12, Week24)
- Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change)(Baseline, Week12, Week24)