Evaluating HMI-115 for pain relief in endometriosis

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 testing a new medication called HMI-115 to see if it can help relieve pain in women with moderate to severe endometriosis.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years to 49 Years
• Sex: Female
• Sponsor: Hope Medicine (Nanjing) Co., Ltd (industry)
• Locations: 5 sites (Draper, Utah and 4 other locations)
• Trial ID: NCT05101317 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and efficacy of HMI-115 compared to a placebo in pre-menopausal women suffering from moderate to severe endometriosis-associated pain over a 12-week period. The trial consists of two parts: the first part will evaluate three different dose levels of HMI-115, while the second part may explore a higher dose based on the results from the first part. Participants will be monitored for pain relief and any adverse effects during the treatment period.

Who should consider this trial

Good fit: Ideal candidates are pre-menopausal women aged 18 to 49 with a clinical diagnosis of endometriosis and moderate to severe associated pain.

Not a fit: Patients with chronic pelvic pain not caused by endometriosis or those with other significant gynecologic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain for women suffering from endometriosis.

How similar studies have performed: Other studies have explored treatments for endometriosis pain, but the specific approach of HMI-115 is novel and has not been widely tested.

Eligibility criteria

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

Where this trial is running

Draper, Utah and 4 other locations

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

Conditions: Endometriosis