A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and efficacy of HMI-115 compared to placebo over a 12 weeks period on subjects with moderate to severe endometriosis-associated pain.

Detailed Description
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This study aims to evaluate the safety and efficacy of HMI-115 versus a placebo in pre-menopausal women with moderate to severe Endometriosis associated pain. Part 1 of the study will determine the safety and efficacy of HMI 115 at 3 dose levels. Part 2 will detect a higher dose and might be conducted after Part 1.

Official Title
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: HMI-115
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent. Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening. Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 with a score of at least 2 for DYS and at least 2 for NMPP at screening. Subject agrees not to participate in another interventional study while participating in the present study. Exclusion Criteria: Subject is pregnant or breastfeeding or is planning a pregnancy during the study period. Subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain Subject has clinically significant gynecologic condition other than endometriosis Subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti inflammatory drugs (NSAIDS) or any contraindication to their use such as gastrointestinal ulcer or bleeding Subject has history of hysterectomy and/or bilateral oophorectomy Subjects with past or present pituitary tumor growth Subjects has a history of osteoporosis or other metabolic bone disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HMI-115 60mg<br>Once Every 2 weeks, subcutaneously injection | Drug: HMI-115<br>* HMI-115 is human monoclonal antibody<br>|
| Active Comparator: HMI-115 120mg<br>Once Every 2 weeks, subcutaneously injection | Drug: HMI-115<br>* HMI-115 is human monoclonal antibody<br>|
| Active Comparator: HMI-115 240mg<br>Once Every 2 weeks, subcutaneously injection | Drug: HMI-115<br>* HMI-115 is human monoclonal antibody<br>|
| Placebo Comparator: Placebo<br>Once Every 2 weeks, subcutaneously injection | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12 | The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DYS measured by NRS from Baseline to Week 24 | The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 24 | 
| Change of non-menstrual pelvic pain (NMPP) measured by NRS from Baseline to Week 12 and 24 | The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, week 12 and 24 | 
| Change in dyspareunia (DYSP) measured by NRS from Baseline to Week 12 and 24 | The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. Higher scores mean a worse outcome. | Baseline, week 12 and 24 | 
| Change from Baseline (CFB) in the monthly mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary | Baseline, week 12 and 24 | 
| CFB by visit in permitted rescue medication use | Assessment was based on average pill counts | Baseline, week 12 and 24 | 
| Change in menstrual period heaviness (bleeding) from Baseline by visit | Assessment was based on tampons or pads used | Baseline, week 12 and 24 |