ISRCTN15654320进行中（未招募）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
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 25/04/2024:
- •1. Provide written informed consent and sign the Informed Consent Form
- •2. Female patients between 18 and 49 years of age inclusive at entering the screening period
- •3. 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.
- •4. Able to comply with study requirements in the Investigator’s judgment
- •5. Agree to use non-hormonal, double-barrier contraception such as a combination of male
- •condom with either cap, diaphragm or sponge with spermicide and refrain from egg collection for preservation or donation.
- •6. Agree to switch from usual analgesics for dysmenorrhea, dyspareunia, and NMPP to
- •analgesics permitted by the study protocol
- •7. Patients who are willing to have laparoscopic surgery after study treatment is completed and understands the surgery may be delayed by participation in the study.
- •8. Has at least 1 full menstrual cycle (21-38 days) during the screening period. The withdrawal
- •bleeding while cyclically using hormonal agents is not considered regular menses
- •9. Has at least 21 days of e-Diary entries during the screening period and completed the e-Diary on at least 75% of days during the screening period. Note: e-Diary vendor will provide an e-Diary compliance report. The investigational site should review the report before randomization to assess eligibility.
- •10. 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)
- •11. Patients who are 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
- •Previous inclusion criteria:
- •1. Provide written informed consent and sign the Informed Consent Form
- •2. Female patients between 18 and 45 years of age inclusive at entering the screening period
- •3. Patient who is diagnosed as having endometriosis by laparoscopy, but have not yet received any surgical treatment at the diagnosis, within 6 months before entering the screening period and who is staged according to the revised American Society of Reproductive Medicine (r-ASRM) score by central readers based on images obtained at the laparoscopic diagnosis
- •4. Not suitable for surgical treatment at laparoscopic diagnosis due to severe condition of the disease
- •5. Able to comply with study requirements in the Investigator’s judgment
- •6. Agree to use non-hormonal, double-barrier contraception such as a combination of male condom with either cap, diaphragm or sponge with spermicide and refrain from egg collection for preservation or donation until 32 weeks after the last administration of AMY109 or AMY109-placebo
- •7. Agree to switch from usual analgesics for dysmenorrhea, dyspareunia, and NMPP to analgesics permitted by the study protocol
- •8. Patient is willing to have laparoscopic surgery after study treatment is completed and understands the surgery will be delayed by participation in the study. Patients must also meet the following criteria for study entry (in addition to 1-8 above):
- •9. Has at least 1 full menstrual cycle (21-38 days) during the screening period. The withdrawal bleeding while cyclically using hormonal agents is not considered regular menses
- •10. Has at least 21 days of e-Diary entries during the screening period and
排除标准
- •1. 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.
- •2. 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).
- •3. Patient has a surgical history of hysterectomy and/or bilateral oophorectomy.
- •4. 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
- •5. Prior treatment with anti-IL-8 antibody preparations
研究者
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