NCT06963177招募中2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS)
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of GenSci048 for moderate to severe endometriosis-associated pain treatment.
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 participants, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
- •Participants must have a diagnosis of endometriosis within 10 years before screening.
- •Have moderate to severe endometrial related pain.
- •Have at least one regular, natural menstrual cycles (ranging from 21 to 35 days (inclusive)) before and during the screening period.
- •Agree to switch from her usual analgesic medication to only that which is permitted in the study from the screening period to the end of treatment and agree to stop using other treatments for endometriosis.
- •Agree to use non-hormonal contraception from the time of signing the informed consent until 4 weeks after the last dose of the study medication.
排除标准
- •Participants who have previously received hysterectomy and/or bilateral oophorectomy, or plan to undergo these procedures during the study period.
- •Participants who suffer from chronic pelvic and/or non-pelvic pain that is not caused by EM and require chronic analgesia or other chronic treatment, which is expected to affect the assessment of EAP.
- •Pelvic ultrasound screening indicating a need for surgery or suspicion of malignancy.
- •Participants with abnormal and undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening.
- •Participants who plan to schedule elective surgery during the study; or those who have had a surgery within 4 months prior to screening and need ongoing pain management.
- •History of severe depression or post-traumatic stress disorder within the two years prior to screening, or history of any other severe mental disorder at any time.
- •History of drug or alcohol abuse within the six months prior to screening.
- •Participants who have participated in any other interventional clinical trial (including clinical trials of drugs and devices) within 1 month prior to screening.
- •Have used a prohibited long-acting anesthetic or immediate-release anesthetic for more than 2 consecutive weeks for the treatment of endometriosis associated pain in the 6 months prior to screening.
- •Participant is pregnant, breast feeding, or planning a pregnancy.
研究组 & 干预措施
GenSci048
Experimental
GenSci048 subcutaneously (SC) every 4 weeks.
干预措施: GenSci048 (Drug)
Placebo
Placebo Comparator
Administered SC every 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS)
时间窗: baseline, week 24
The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Change of non-menstrual pelvic pain (NMPP) measured by Numeric Rating Scale (NRS)
时间窗: baseline, week 24
The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
次要结局
- Change of DYS, NMPP, and dyspareunia (DYSP) measured by Numeric Rating Scale (NRS). The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.(52 weeks)
- Permitted rescue medication use.(52 weeks)
- Patient Global Impression of Change, Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome).(Week 12、Week 24、Week 52)
- Adverse Event(up to approximately 56 weeks)
研究者
研究点 (1)
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