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

NCT ID: NCT05101317

Last Updated: 2025-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2025-03-19

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.

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

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HMI-115 60mg

Once Every 2 weeks, subcutaneously injection

Group Type ACTIVE_COMPARATOR

HMI-115

Intervention Type DRUG

HMI-115 is human monoclonal antibody

HMI-115 120mg

Once Every 2 weeks, subcutaneously injection

Group Type ACTIVE_COMPARATOR

HMI-115

Intervention Type DRUG

HMI-115 is human monoclonal antibody

HMI-115 240mg

Once Every 2 weeks, subcutaneously injection

Group Type ACTIVE_COMPARATOR

HMI-115

Intervention Type DRUG

HMI-115 is human monoclonal antibody

Placebo

Once Every 2 weeks, subcutaneously injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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HMI-115

HMI-115 is human monoclonal antibody

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hope Medicine (Nanjing) Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Physicians' Research Options, LLC- Corner Canyon Clinic

Draper, Utah, United States

Site Status

Tidewater Clinical Research/TPW

Norfolk, Virginia, United States

Site Status

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Instytut Matki i Dziecka

Warsaw, Masovian Voivodeship, Poland

Site Status

Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Countries

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United States China Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HMI-115EM201

Identifier Type: -

Identifier Source: org_study_id