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

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Placebo; Drug: HMI-115

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.

The study will determine the safety and efficacy of HMI 115 at 3 dose levels.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100703
      • Peking Union Medical College Hospital
• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland
      • Instytut Matki i Dziecka
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland
      • Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego
• United States
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians' Research Options, LLC- Corner Canyon Clinic
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research/TPW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Once Every 2 weeks, subcutaneously injection	Drug: Placebo; Placebo
Experimental: HMI-115 60mg; Once Every 2 weeks, subcutaneously injection	Drug: HMI-115; HMI-115 is human monoclonal antibody
Experimental: HMI-115 120mg; Once Every 2 weeks, subcutaneously injection	Drug: HMI-115; HMI-115 is human monoclonal antibody
Experimental: HMI-115 240mg; Once Every 2 weeks, subcutaneously injection	Drug: HMI-115; HMI-115 is human monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)	The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.	Baseline, Week 12
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change）	The Numeric Rating Scale for dysmenorrhea 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 Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)	The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.	Baseline, Week 24
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change)	The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) 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 (Percentage Change)	The Numering Rating Score for dyspareunia ranges from 0 (no pain) to 10 (severe pain). 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. The higher scores mean worse outcome.	Baseline, week 12 and 24
Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use	Assessment was based on average pill counts at each apecific period od days	Baseline, week 12 and 24
Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit	Assessment was based on tampons or pads used. 0 means no bleeding, 4 means heavy bleeding. Higher score means more bleeding.	Baseline, week 12 and 24
Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change)	The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.	Baseline, Week 24
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change)	The Numeric Rating Scale (NRS) for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.	Baseline, Week12, Week24
Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change)	The Numering Rating Score(NRS) for dyspareunia(DYSP) ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.	Baseline, Week12, Week24

Collaborators and Investigators

• Sponsor: Hope Medicine (Nanjing) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): March 19, 2025

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: HMI-115EM201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No