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

NCT05101317 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HMI-115EM201
• Study Type: interventional
• Target: 142
• Locations: 3 countries
• Sites: 5

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)

  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)

  Baseline, week 12 and 24

• Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change)

  Baseline, week 12 and 24

• Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP

  Baseline, week 12 and 24

• Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use

  Baseline, week 12 and 24

Study Arms (4)

HMI-115 60mg

EXPERIMENTAL

Once Every 2 weeks, subcutaneously injection

Drug: HMI-115

HMI-115 120mg

EXPERIMENTAL

Once Every 2 weeks, subcutaneously injection

Drug: HMI-115

HMI-115 240mg

EXPERIMENTAL

Once Every 2 weeks, subcutaneously injection

Drug: HMI-115

Placebo

PLACEBO COMPARATOR

Once Every 2 weeks, subcutaneously injection

Drug: Placebo

Interventions

HMI-115 DRUG

HMI-115 is human monoclonal antibody

HMI-115 120mg; HMI-115 240mg; HMI-115 60mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

Physicians' Research Options, LLC- Corner Canyon Clinic

Draper, Utah, 84020, United States

Location

Tidewater Clinical Research/TPW

Norfolk, Virginia, 23502, United States

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100703, China

Location

Instytut Matki i Dziecka

Warsaw, Masovian Voivodeship, Poland

Location

Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego

Bialystok, Podlaskie Voivodeship, Poland

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. Ruiping Xiao
• Organization: Peking University

xiaor@pku.edu.cn

86-010-62757243

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: November 1, 2021
• Study Start: October 11, 2021
• Primary Completion: September 26, 2024
• Study Completion: March 19, 2025
• Last Updated: January 21, 2026
• Results First Posted: November 18, 2025

Record last verified: 2026-01

Locations

CN (1); PL (2); US (2)