NCT07318688

Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 24-Week Treatment Period and a 28-Week Extension

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Hope Medicine (Nanjing) Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

A phase 3 study to evaluate the efficacy and safety of HMI-115 in women with moderate to severe endometriosis-associated pain over a 24-week treatment period and a 28-week extension

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	HMI-115	HMI-115 is human monoclonal antibody （120mg/vail）
DRUG	Placebo	Placebo （0mg/vail）

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-09-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated drug study