NCT05101317

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Hope Medicine (Nanjing) Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	HMI-115	HMI-115 is human monoclonal antibody
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-10-11
• Primary completion: 2024-09-26
• Completion: 2025-03-19
• First posted: 2021-11-01
• Last updated: 2026-01-21
• Results posted: 2025-11-18

Locations

5 sites across 3 countries: United States, China, Poland

Regulatory

• FDA-regulated drug study