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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101317
• Other study ID #: HMI-115EM201
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2021
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: Hope Medicine (Nanjing) Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• HMI-115
HMI-115 is human monoclonal antibody
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
Poland	Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego	Bialystok	Podlaskie
Poland	Instytut Matki i Dziecka	Warszawa	Mazowieckie
United States	Physicians' Research Options, LLC- Corner Canyon Clinic	Draper	Utah
United States	Tidewater Clinical Research/TPW	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hope Medicine (Nanjing) Co., Ltd

Countries where clinical trial is conducted

United States,  China,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 24
Secondary	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.	Baseline, week 12 and 24
Secondary	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.	Baseline, week 12 and 24
Secondary	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	Baseline, week 12 and 24
Secondary	CFB by visit in permitted rescue medication use	Assessment was based on average pill counts	Baseline, week 12 and 24
Secondary	Change in menstrual period heaviness (bleeding) from Baseline by visit	Assessment was based on tampons or pads used	Baseline, week 12 and 24