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A study to evaluate the efficacy and safety of AMY109 in women with endometriosis
EU CTIS ID: 2023-507289-14-00
What this study is testing
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)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.