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

Sponsor

Hope Medicine (Nanjing) Co., Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05101317

Collaborator

(none)

152

Enrollment

Locations

Arms

22.7

Anticipated Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: HMI-115 Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

152 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 11, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12 [Baseline, 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 [Baseline, 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 [Baseline, 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 [Baseline, 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 [Baseline, week 12 and 24]
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 [Baseline, week 12 and 24]
Assessment was based on average pill counts
Change in menstrual period heaviness (bleeding) from Baseline by visit [Baseline, week 12 and 24]
Assessment was based on tampons or pads used

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physicians' Research Options, LLC- Corner Canyon Clinic	Draper	Utah	United States	84020
2	Tidewater Clinical Research/TPW	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

Hope Medicine (Nanjing) Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hope Medicine (Nanjing) Co., Ltd

ClinicalTrials.gov Identifier:

NCT05101317

Other Study ID Numbers:

HMI-115EM201

First Posted:

Nov 1, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Mar 31, 2022