NCT07318688
Not yet recruiting
Phase 3
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
Hope Medicine (Nanjing) Co., Ltd5 sites in 1 country540 target enrollmentStarted: March 1, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Hope Medicine (Nanjing) Co., Ltd
- Enrollment
- 540
- Locations
- 5
- Primary Endpoint
- Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1\. Premenopausal female subjects, between 18 and 49 years of age, inclusive.
- •2\. Has a surgical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
- •3\. Has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at screening with a score of at least 2 for DYS and at least 2 for NMPP.
- •4\. Subject has reported "moderate" or "severe" for her endometriosis-associated DYS AND NMPP before randomization.
- •5\. Subject has at least two consecutive regular menstrual cycle (i.e. 21 to 35 days in duration) prior to randomization.
- •6\. Subject agrees to use required (nonhormonal) birth control methods during the entire length of participation in the study and agrees to avoid pregnancy from signing the informed consent until 12 weeks after the last dose.
- •7\. Subject agrees to use only those rescue analgesic medications permitted by the protocol during the Screening, Treatment and Posttreatment follow-up Periods for her endometriosis-associated pain.
- •8\. Criteria for Extension Treatment Period：Subject who completes treatment of the placebo-controlled double-blind treatment period and assessments at Week 24.
Exclusion Criteria
- •1\. Subject who is pregnant or breastfeeding or is planning a pregnancy during the study period or is less than 6 months post-partum or 3 months post-abortion at the time of entry into the Screening Period or pregnancy before randomization.
- •2\. Subject has an intra-uterine device (IUD). Subject is eligible if she removes the IUD 1 month before screening.
- •3\. Subject has chronic pelvic pain that is not caused by endometriosis (e.g., interstitial cystitis, irritable bowel syndrome) or has any other chronic pain syndrome (e.g., fibromyalgia, chronic back pain, myofascial pain syndrome, chronic headaches) that requires chronic analgesic or other chronic therapy, which would interfere with the assessment of endometriosis-associated pain.
- •4\. Subject with a current history of undiagnosed abnormal genital bleeding.
- •5\. Subject with history of hysterectomy and/or bilateral oophorectomy.
- •6\. Subject has had surgery for endometriosis within 6 weeks prior to entry into the Screening Period.
- •7\. 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.
- •8\. Subject with known hypersensitivity to any of the IMP ingredients.
- •9\. Subject has an estimated glomerular filtration rate (eGFR) of \< 60mL/min/1.73 m2 at Screening Period.
- •10\. Subject is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to the start of Screening Period or 5 half-lives, whichever is longer.
Arms & Interventions
HMI-115_120mg
Experimental
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 )
Intervention: HMI-115 (Drug)
HMI-115_240mg
Experimental
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 )
Intervention: HMI-115 (Drug)
Placebo
Placebo Comparator
2ml , Once Every 2 weeks, subcutaneously injection,total of 12 injections (Week 0 to Week 24)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12
Time Frame: week 12
CFB in non-menstrual pelvic pain (NMPP) measured by NRS at Week 12
Time Frame: week 12
Secondary Outcomes
- CFB in DYS measured by NRS at Week 24(week 24)
- CFB in NMPP measured by NRS at Week 12(week 24)
- CFB in average overall pelvic pain measured by NRS at Week 12 and week 24(Week 12 and week 24)
- CFB in DYSP measured by NRS at Week 12 and week 24(Week 12 and week 24)
- Changes in the number of remedial analgesics allowed to be used compared to baseline(Week 12 and week 24)
- Adverse Events(During the clinical study period)
- To investigate the pharmacokinetics (PK) characteristic of HMI-115, Serum trough concentrations at each time point and descriptive statistics.(Before the first intervention、Week 2、Week 4、Week 8、Week 12、Week 16、Week 20、Week 24、Week 32、Week 40、Week 52)
- To investigate the immunogenicity of HMI-115：Anti-drug antibody (ADA) and Neutralizing antibody (NABs)(Before the first intervention、Week 2、Week 4、Week 8、Week 12、Week 16、Week 20、Week 24、Week 32、Week 40、Week 52)
Investigators
Study Sites (5)
Loading locations...
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