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

Sponsor
Hope Medicine (Nanjing) Co., Ltd
Study ID
NCT07318688
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • HMI-115 — DRUG
    HMI-115 is human monoclonal antibody （120mg/vail）
  • Placebo — DRUG
    Placebo （0mg/vail）

Study Details

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

Key Dates

First listed
Jan 6, 2026
Start date
Jan 29, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HMI-115_120mg
    120mg, Once Every 2 weeks, subcutaneously injection,total of 26 injections (Week 0 to Week 52) or total of 14 injections (Week 24 to Week 52/Extension Treatment Period of Placebo )
  • Experimental: HMI-115_240mg
    240mg, Once Every 2 weeks, subcutaneously injection,total of 26 injections (Week 0 to Week 52) or total of 14 injections (Week 24 to Week 52/Extension Treatment Period of Placebo )
  • Placebo Comparator: Placebo
    2ml , Once Every 2 weeks, subcutaneously injection,total of 12 injections (Week 0 to Week 24)

Primary Outcome Measure

Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12 [ Time Frame: week 12 ]

Central Contacts

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