2023-507289-14-00招募中2 期
A PHASE II, RANDOMIZED, DOUBLE BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AMY109 IN WOMEN WITH ENDOMETRIOSIS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 12
- 主要终点
- Changes of total score and stage in the revised American Society of Reproductive Medicine (r-ASRM) score assessed by laparoscopy from pre-treatment to post-treatment (only in the UK) Change in sum of long (i.e., the largest) diameters of endometriotic nodules assessed by MRI from pre-treatment to post-treatment
研究概览
简要总结
To evaluate the efficacy of both (i) AMY109 and (ii) AMY109 and desogestrel compared with (iii) desogestrel in disease severity assessed by laparoscopic appearance in women with endometriosis ((only in the UK) To evaluate the efficacy of both (i) AMY109 and (ii) AMY109 and desogestrel compared with (iii) desogestrel in disease severity assessed by magnetic resonance imaging (MRI)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients between 18 and 49 years of age inclusive at the time of written informed consent
- •Agree to switch from usual analgesics for dysmenorrhea, dyspareunia, and NMPP to analgesics permitted by the study protocol
- •Has moderate to severe endometriosis-associated NMPP (NRS score of ≥4 on ≥ 4 days of the screening period) and dysmenorrhea (NRS score of ≥4 on ≥ 2 days of the screening period)
- •The laparoscopy cohort only (only in the UK): Patient who is willing to have laparoscopic surgery after study treatment is completed and understands the surgery may be delayed by participation in the study. • The investigators should confirm the patient is clinically suitable for receiving a surgical treatment for her endometriosis
- •The laparoscopy cohort only(only in the UK): Patients who have received a laparoscopic diagnosis within 9 months before entering the screening period but have not received any surgical treatment at the laparoscopic diagnosis (for example due to severity of disease). • This diagnostic laparoscopy should have been conducted outside of the study in line with standard practice • Biopsies taken at laparoscopic diagnosis which are not considered treatments are permitted
- •The laparoscopy cohort only(only in the UK): Patient who is staged Ⅲ/Ⅳ endometriosis according to the revised American Society of Reproductive Medicine (r-ASRM) score by central readers based on images obtained at the laparoscopic diagnosis • Videos/operational records or notes can be used to support staging the score if available
- •The imaging cohort only(only in the EU): Patient who has clinical diagnosis of endometriosis based on at least one of the following criteria: • Laparoscopy/laparotomy performed within 10 years before written informed consent • Clinical symptoms and imaging assessment (i.e., TVUS or MRI) before entering treatment period. Patient must have at least one ovarian endometrioma on MRI assessed by a central reader during the screening period
- •The imaging cohort only(only in the EU): Patient who has at least 1 endometriotic nodule with > 5mm short diameter and > 10 mm long diameter using MRI assessed by a central reader during the screening period • Patients with a nodule indistinct from adenomyosis can be enrolled if another endometriotic nodule or endometrioma is identified during the screening period
排除标准
- •Clinically significant abnormalities in laboratory test results, physical examination, vital signs, 12-lead ECG, chest X-ray, hematology (e.g., Hemoglobin [Hb] < 90 g/L), blood chemistry, serology, and urinalysis at screening
- •Patient has chronic pelvic pain that is not caused by endometriosis and that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g. pelvic inflammatory disease)
- •Patient has a surgical history of hysterectomy and/or bilateral oophorectomy
- •Prior treatment with antibody preparations (commercially available or investigational) within 6 months or 5 half-lives of the drug, whichever is longer, before entering the screening period
- •Prior treatment with anti-IL-8 antibody preparations
结局指标
主要结局
Changes of total score and stage in the revised American Society of Reproductive Medicine (r-ASRM) score assessed by laparoscopy from pre-treatment to post-treatment (only in the UK) Change in sum of long (i.e., the largest) diameters of endometriotic nodules assessed by MRI from pre-treatment to post-treatment
Changes of total score and stage in the revised American Society of Reproductive Medicine (r-ASRM) score assessed by laparoscopy from pre-treatment to post-treatment (only in the UK) Change in sum of long (i.e., the largest) diameters of endometriotic nodules assessed by MRI from pre-treatment to post-treatment
次要结局
未报告次要终点
研究者
Clinical trials information
Scientific
Chugai Pharmaceutical Co. Ltd.
研究点 (12)
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