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

January 3, 2026 updated by: Hope Medicine (Nanjing) Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)
Time Frame: Baseline, Week 12
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）
Time Frame: Baseline, Week 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)
Time Frame: Baseline, Week 24
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)
Time Frame: Baseline, week 12 and 24
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)
Time Frame: Baseline, week 12 and 24
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
Time Frame: Baseline, week 12 and 24
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
Time Frame: Baseline, week 12 and 24
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
Time Frame: Baseline, week 12 and 24
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)
Time Frame: Baseline, Week 24
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)
Time Frame: Baseline, Week12, Week24
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)
Time Frame: Baseline, Week12, Week24
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hope Medicine (Nanjing) Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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