AMY109 for Endometriosis

Inclusion criteria

• {"criterion_text":"- Female patients between 18 and 49 years of age inclusive at the time of written informed consent\n- Agree to switch from usual analgesics for dysmenorrhea, dyspareunia, and NMPP to analgesics permitted by the study protocol\n- 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)\n- 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\n- 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\n- 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\n- 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\n- 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"}

Exclusion criteria

• {"criterion_text":"- 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\n- 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)\n- Patient has a surgical history of hysterectomy and/or bilateral oophorectomy\n- 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\n- Prior treatment with anti-IL-8 antibody preparations"}

Primary endpoints

• {"endpoint_text":"- 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)\n- Change in sum of long (i.e., the largest) diameters of endometriotic nodules assessed by MRI from pre-treatment to post-treatment","definition_or_measurement_approach":"Assessment by laparoscopy using the revised ASRM score (pre-treatment vs post-treatment) for laparoscopic cohort (UK); central-read MRI measurement of sum of longest diameters of endometriotic nodules (pre-treatment vs post-treatment) for imaging cohort."}

Methods

• Country-specific patient brochures and patient study guides (documents available in EN, PL, RO, CZ)
• Patient posters and patient posters (country-specific versions)
• Doctor-to-patient letters and physician referral brochures (materials for clinicians to refer patients)
• Animation video storyboard (digital outreach material)
• Patient advertisement / Patient appreciation items / Thank you cards
• Medication instruction cards and patient ID cards
• Study-specific recruitment arrangements documents (K1/K2) per country

Romania

Earliest CTIS Part Ii Submission Date

19-04-2024

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

745

Number Of Sites

2

Number Of Participants

23

Czechia

Earliest CTIS Part Ii Submission Date

18-04-2024

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

748

Number Of Sites

1

Number Of Participants

14

Poland

Earliest CTIS Part Ii Submission Date

09-05-2024

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

720

Number Of Sites

7

Number Of Participants

43

Primary sponsor

Full Name

Chugai Pharmaceutical Co. Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Japan

Contract research organisations

Name

IQVIA Limited

Responsibilities

1,12,2,3,5,8

Name

Iqvia Laboratories Limited

Responsibilities

4

Name

IQVIA Laboratories LLC

Responsibilities

4

Name

Cmic Inc.

Responsibilities

4

Third parties

• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Cmic Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1,12,2,3,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"IQVIA Laboratories LLC","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Japan","full_name":"Riken Genesis Co. Ltd.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Specialty Laboratories Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Japan","full_name":"Takara Bio Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Japan","full_name":"Cmic Pharma Science Co. Ltd.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Japan","full_name":"Mediford Corp.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Japan","full_name":"Micron Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Cerba","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}