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

NCT07318688 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-01-06

No results posted yet for this study

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

DRUG

HMI-115

HMI-115 is human monoclonal antibody （120mg/vail）

DRUG

Placebo

Placebo （0mg/vail）

Sponsors & Collaborators

  • Hope Medicine (Nanjing) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-03-01
Completion
2028-09-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318688 on ClinicalTrials.gov