Endometriosis Urological and Genital Diseases
Conditions
Interventions
Current interventions as of 03/02/2026:
Period 1: 4–12-week washout period, required for participants receiving certain types of medication.
Period 2: 21–45-day screening period, to confirm participan
Sponsors
Chugai Pharma Europe Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in size of ovarian endometrioma assessed by MRI from baseline to Week 37 and 53. 2. Change in size of endometriotic nodule assessed by MRI from baseline to Week 37 and 53. 3. Change in adhesions assessed by MRI from baseline to Week 37 and 53. 4. Change of grade in the ENZIAN classification assessed by MRI from baseline to Week 37 and 53. 5. Change in the MEDL score assessed by MRI from baseline to Week 37 and 53. 6. Change in size of ovarian endometrioma from baseline to Week 25 and 53 assessed by transvaginal ultrasound (TVUS) 7.Change in size of endometriotic nodule from baseline to Week 25 and 53 assessed by TVUS 8. Change in adhesions from baseline to Week 25 and 53 assessed by TVUS 9. Change in monthly mean endometriosis associated pain scores (dysmenorrhea, dyspareunia, and NMPP) from baseline to each month as recorded by daily completion of an 11–point numerical rating scale (NRS) using an electronic diary (Baseline and then monthly up to Week 105) 10. Change in monthly mean endometriosis associated pain scores (dysmenorrhea, dyspareunia, and NMPP) from baseline to each month measured by the modified Biberoglu and Behrman Scale (mBBS) using an electronic diary on daily basis (Baseline and then monthly up to Week 105) 11. Change in monthly mean number of days of analgesics use to treat endometriosis associated pain from baseline to each month as recorded by daily completion of an electronic diary (Baseline and then monthly up to Week 105) 12. Change in monthly mean dose of analgesics use to treat endometriosis associated pain from baseline to each month as recorded by daily completion of an electronic diary (Baseline and then monthly up to Week 105) 13. Incidence and severity of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and adverse drug reactions up to Week 105 14. Vital signs (pulse rate, blood pressure, body temperature). Screening until Week 105. 15.12-lead electrocardiograms (ECGs). Scr | — |
Countries
England, United Kingdom
Outcome results
None listed