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

Hope Medicine

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: HMI-115

Study type: Interventional

Funder types: Industry

Identifiers

NCT05101317

HMI-115EM201

Details and patient eligibility

About

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.

Full 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.

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

Enrollment: 142 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 4 patient groups, including a placebo group

HMI-115 60mg

Experimental group

Description:

Once Every 2 weeks, subcutaneously injection

Treatment:

Drug: HMI-115

HMI-115 120mg

Experimental group

Description:

Once Every 2 weeks, subcutaneously injection

Treatment:

Drug: HMI-115

HMI-115 240mg

Experimental group

Description:

Once Every 2 weeks, subcutaneously injection

Treatment:

Drug: HMI-115

Placebo

Placebo Comparator group

Description:

Once Every 2 weeks, subcutaneously injection

Treatment:

Drug: Placebo