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

NCT07318688 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: HMI-115ENDO302
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 5

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

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12

  week 12

• CFB in non-menstrual pelvic pain (NMPP) measured by NRS at Week 12

  week 12

Secondary Outcomes (8)

• 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

Study Arms (3)

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 )

Drug: HMI-115

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 )

Drug: HMI-115

Placebo

PLACEBO COMPARATOR

2ml , Once Every 2 weeks, subcutaneously injection,total of 12 injections (Week 0 to Week 24)

Drug: Placebo

Interventions

Placebo DRUG

Placebo （0mg/vail）

Placebo

HMI-115 DRUG

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

HMI-115_120mg; HMI-115_240mg

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Premenopausal female subjects, between 18 and 49 years of age, inclusive.
• \. Has a surgical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
• \. 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.
• \. Subject has reported "moderate" or "severe" for her endometriosis-associated DYS AND NMPP before randomization.
• \. Subject has at least two consecutive regular menstrual cycle (i.e. 21 to 35 days in duration) prior to randomization.
• \. 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.
• \. 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.
• \. Criteria for Extension Treatment Period：Subject who completes treatment of the placebo-controlled double-blind treatment period and assessments at Week 24.

You may not qualify if:

• \. 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.
• \. Subject has an intra-uterine device (IUD). Subject is eligible if she removes the IUD 1 month before screening.
• \. 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.
• \. Subject with a current history of undiagnosed abnormal genital bleeding.
• \. Subject with history of hysterectomy and/or bilateral oophorectomy.
• \. Subject has had surgery for endometriosis within 6 weeks prior to entry into the Screening Period.
• \. 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.
• \. Subject with known hypersensitivity to any of the IMP ingredients.
• \. Subject has an estimated glomerular filtration rate (eGFR) of \< 60mL/min/1.73 m2 at Screening Period.
• \. 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.
• \. Subject who has been exposed to HMI-115 treatment.
• \. Subject has used medications such as hormones, analgesics, medications associated with bone loss, products that affect PRL levels, etc. within specific time window before Screening.
• \. Subject has clinically significantly abnormal laboratory tests at Screening Period, including:
• Alanine transaminase (ALT/SGPT), or aspartate aminotransferase (AST/SGOT) ≥200% of the upper limit of normal, or total bilirubin (unless known diagnosis of Gilbert's syndrome) ≥ 150% of the upper limit of normal range.
• Hemoglobin \< 100 g/L, Neutrophil count \< 1.5×109/ L, Platelet count \< 100×109/ L.

Sponsors & Collaborators

• Hope Medicine (Nanjing) Co., Ltd: lead

Study Sites (5)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100703, China

Location

Nanjing Women and children's healthcare hospital

Nanning, Jiangsu, China

Location

Second Affiliated Hospital of Soochow University

Suzhu, Jiangsu, China

Location

The International Peace Maternity and Child Health Hospital of the China Welfare Institute

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Xu Yeqing

CONTACT

86-18717858198; yeqing.xu@hopemedinc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1）Placebo-Controlled Double-blind Treatment Period (Week 0 to Week 24): Subjects will be randomized in a 1:1:1 ratio to receive subcutaneous (s.c.) injection with HMI-115 120 mg, HMI-115 240 mg or placebo every two weeks (Q2W). A total of 12 injections will be administered. 2\) Extension Treatment Period (Week 24 to Week 52): All eligible subjects who received placebo in the placebo-controlled double-blinded period will be randomized in a 1:1 ratio to receive HMI-115 120 mg Q2W or HMI-115 240 mg Q2W in the extension treatment period until Week 50, followed by an evaluation (Visit 29/EOT Visit) at Week 52. All eligible subjects in the active treatment groups will continue their treatment. A total of 14 injections will be administered.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)