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

Primary Purpose

Endometriosis

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

HMI-115

Placebo

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Physicians' Research Options, LLC- Corner Canyon Clinic
Tidewater Clinical Research/TPW
Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HMI-115 60mg

HMI-115 120mg

HMI-115 240mg

Placebo

Arm Description

Once Every 2 weeks, subcutaneously injection

Outcomes

Primary Outcome Measures

Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to 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

Change in DYS measured by NRS from Baseline to 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

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

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

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

Assessment was based on average pill counts

Change in menstrual period heaviness (bleeding) from Baseline by visit

Assessment was based on tampons or pads used

Full Information

NCT ID

NCT05101317

First Posted

October 9, 2021

Last Updated

October 8, 2023

Sponsor

Hope Medicine (Nanjing) Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05101317

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 11, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hope Medicine (Nanjing) Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HMI-115 60mg

Arm Type

Active Comparator

Arm Description

Once Every 2 weeks, subcutaneously injection

Arm Title

HMI-115 120mg

Arm Type

Active Comparator

Arm Description

Once Every 2 weeks, subcutaneously injection

Arm Title

HMI-115 240mg

Arm Type

Active Comparator

Arm Description

Once Every 2 weeks, subcutaneously injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Once Every 2 weeks, subcutaneously injection

Intervention Type

Drug

Intervention Name(s)

HMI-115

Intervention Description

HMI-115 is human monoclonal antibody

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12

Description

The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change in DYS measured by NRS from Baseline to Week 24

Description

The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.

Time Frame

Baseline, Week 24

Title

Change of non-menstrual pelvic pain (NMPP) measured by NRS from Baseline to Week 12 and 24

Description

The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.

Time Frame

Baseline, week 12 and 24

Title

Change in dyspareunia (DYSP) measured by NRS from Baseline to Week 12 and 24

Description

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.

Time Frame

Baseline, week 12 and 24

Title

Change from Baseline (CFB) in the monthly mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP

Description

Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary

Time Frame

Baseline, week 12 and 24

Title

CFB by visit in permitted rescue medication use

Description

Assessment was based on average pill counts

Time Frame

Baseline, week 12 and 24

Title

Change in menstrual period heaviness (bleeding) from Baseline by visit

Description

Assessment was based on tampons or pads used

Time Frame

Baseline, week 12 and 24

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Facility Information:

Facility Name

Physicians' Research Options, LLC- Corner Canyon Clinic

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Individual Site Status

Terminated

Facility Name

Tidewater Clinical Research/TPW

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Individual Site Status

Terminated

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100703

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

lan zhu

Phone

8621-69156204

zhu_julie@vip.sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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