EndometriosisPhase 3NCT07318688
Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain
A Phase 3 study testing HMI-115 in people with Endometriosis, run by Hope Medicine (Nanjing) Co., Ltd at 5 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- HMI-115
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 5 sitesChina
- Study dates
- 29 Jan 2026to 1 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 11. Subject who has been exposed to HMI-115 treatment.
- 12. 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.
- 13. 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.
- 14. Subject has clinically significantly abnormal laboratory tests at Screening Period, including: Neutrophil count < 1.5×109/ L, Platelet count < 100×109/ L.
- 15. Subject has clinically significant abnormal ECG, or ECG with QTcF > 450 msec at Screening Period.
- 16. Subject has a history or current has malignancy except for treated basal cell carcinoma and cutaneous squamous cell carcinoma of the skin.
- 17. Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the study.
- 18. Subject has any of the following conditions within the last 6 months before Screening:
- Myocardial infarction, stroke, unstable angina or transient ischemic attack.
- Classified as being in New York Heart Association Class III or IV.
- 19. Subjects with body weight greater than 300 pounds or 136 kilograms.
- 20. Any other conditions in the Investigator's opinion that prevent the subject from participating.
- 21. Criteria for Extension Treatment Period： Subjects entering the follow-up period after treatment: subjects with a BMD decrease of ≥ 8.0% or Z-value ≤ -2.0 in any part of the lumbar spine, femoral neck, or total hip compared to baseline.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100703
Zhu Lan, Ph.D.
- Not yet recruiting
Nanjing Women and children's healthcare hospital
Nanning, Jiangsu
Ruan Hongjie
- Not yet recruiting
The International Peace Maternity and Child Health Hospital of the China Welfare Institute
Shanghai, Shanghai Municipality
Xu Hong
- Recruiting
Second Affiliated Hospital of Soochow University
Suzhu, Jiangsu
Zhu Weipei
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Xue Fengxia
About this study
Official title: 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
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
- Being tested
- HMI-115, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMI-115Drug
HMI-115 is human monoclonal antibody （120mg/vail）
PlaceboDrug
Placebo （0mg/vail）
| Study group | Role | What they receive |
|---|---|---|
| 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 ) Receives: 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 ) Receives: Drug: HMI-115 |
| Placebo | Placebo comparator | 2ml , Once Every 2 weeks, subcutaneously injection,total of 12 injections (Week 0 to Week 24) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12
Measured: week 12
CFB in non-menstrual pelvic pain (NMPP) measured by NRS at Week 12
Measured: week 12
Secondary outcomes (8)
CFB in DYS measured by NRS at Week 24
Measured: week 24
CFB in NMPP measured by NRS at Week 12
Measured: week 24
CFB in average overall pelvic pain measured by NRS at Week 12 and week 24
Measured: Week 12 and week 24
CFB in DYSP measured by NRS at Week 12 and week 24
Measured: Week 12 and week 24
Changes in the number of remedial analgesics allowed to be used compared to baseline
Measured: Week 12 and week 24
Adverse Events
64 Weeks
Measured: During the clinical study period
To investigate the pharmacokinetics (PK) characteristic of HMI-115, Serum trough concentrations at each time point and descriptive statistics.
Serum trough concentrations at each time point and descriptive statistics.
Measured: 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)
Measured: Before the first intervention、Week 2、Week 4、Week 8、Week 12、Week 16、Week 20、Week 24、Week 32、Week 40、Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start29 Jan 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hope Medicine (Nanjing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318688
- Sponsor's protocol ID
- HMI-115ENDO302
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07318688
- Acronym / sponsor ID
- HMI-115ENDO302
- Conditions
- Endometriosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Hope Medicine (Nanjing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HMI-115_120mg | Experimental | Drug: HMI-115120mg, 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 ) |
| HMI-115_240mg | Experimental | Drug: HMI-115240mg, 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 | Placebo comparator | Drug: Placebo2ml , Once Every 2 weeks, subcutaneously injection,total of 12 injections (Week 0 to Week 24) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMI-115HMI-115 is human monoclonal antibody （120mg/vail） | Drug | HMI-115_120mg, HMI-115_240mg |
| PlaceboPlacebo （0mg/vail） | Drug | Placebo |
Primary outcome
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
8 secondary outcomes
CFB in DYS measured by NRS at Week 24
Time frame: week 24
CFB in NMPP measured by NRS at Week 12
Time frame: week 24
CFB in average overall pelvic pain measured by NRS at Week 12 and week 24
Time frame: Week 12 and week 24
CFB in DYSP measured by NRS at Week 12 and week 24
Time frame: Week 12 and week 24
Changes in the number of remedial analgesics allowed to be used compared to baseline
Time frame: Week 12 and week 24
Adverse Events
Time frame: During the clinical study period
To investigate the pharmacokinetics (PK) characteristic of HMI-115, Serum trough concentrations at each time point and descriptive statistics.
Time frame: 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)
Time frame: Before the first intervention、Week 2、Week 4、Week 8、Week 12、Week 16、Week 20、Week 24、Week 32、Week 40、Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HMI-115 in people with Endometriosis, run by Hope Medicine (Nanjing) Co., Ltd at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Yeqing (86-18717858198, yeqing.xu@hopemedinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12 (time frame: week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.