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

Phase 2

Recruiting

• Conditions: Endometriosis
• Interventions: Drug: HMI-115; Drug: Placebo

• Registration Number: NCT05101317
• Lead Sponsor: Hope Medicine (Nanjing) Co., Ltd

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-10-09
• Study Start: 2021-10-11
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

1. Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
2. Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
3. 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.
4. Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria

1. Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
2. 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
3. Subject has clinically significant gynecologic condition other than endometriosis
4. 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
5. Subject has history of hysterectomy and/or bilateral oophorectomy
6. Subjects with past or present pituitary tumor growth
7. Subjects has a history of osteoporosis or other metabolic bone disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMI-115 60mg	HMI-115	Once Every 2 weeks, subcutaneously injection
HMI-115 120mg	HMI-115	Once Every 2 weeks, subcutaneously injection
HMI-115 240mg	HMI-115	Once Every 2 weeks, subcutaneously injection
Placebo	Placebo	Once Every 2 weeks, subcutaneously injection

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Physicians' Research Options, LLC- Corner Canyon Clinic; 🇺🇸 Draper, Utah, United States

Tidewater Clinical Research/TPW; 🇺🇸 Norfolk, Virginia, United States

Instytut Matki i Dziecka; 🇵🇱 Warszawa, Mazowieckie, Poland

Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego; 🇵🇱 Bialystok, Podlaskie, Poland