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This study is designed to evaluate the safety and efficacy of HMI-115 compared to placebo over a 12 weeks period on subjects with moderate to severe endometriosis-associated pain.
This study aims to evaluate the safety and efficacy of HMI-115 versus a placebo in pre-menopausal women with moderate to severe Endometriosis associated pain.
The study will determine the safety and efficacy of HMI 115 at 3 dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMI-115 60mg | Experimental | Once Every 2 weeks, subcutaneously injection |
|
| HMI-115 120mg | Experimental | Once Every 2 weeks, subcutaneously injection |
|
| HMI-115 240mg | Experimental | Once Every 2 weeks, subcutaneously injection |
|
| Placebo | Placebo Comparator | Once Every 2 weeks, subcutaneously injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMI-115 | Drug | HMI-115 is human monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 12 |
| Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 24 |
| Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians' Research Options, LLC- Corner Canyon Clinic | Draper | Utah | 84020 | United States | ||
| Tidewater Clinical Research/TPW |
1. Screening Period: up to 75 days prior to first dose
The study was conducted in China, the United States of America (USA), and Poland.Total of 310 subjects were screened, of which 142 subjects were randomized. Among them, 36 subjects received HMI-115 60 mg, 36 received HMI-115 120 mg, 35 received HMI-115 240 mg, and 35 subjects were randomized to receive placebo. In the protocol version 5.0, part 2 of the study was deleted and not executed. So no subject was recruited in the former planned part 2 study.
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| ID | Title | Description |
|---|---|---|
| FG000 | HMI-115 60mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| FG001 | HMI-115 120mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| FG002 | HMI-115 240mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| FG003 | Placebo | Once Every 2 weeks, subcutaneously injection Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week1-13 |
|
| ||||||||||||||||||
| Week 13-25 |
|
PAS：All subjects in the FAS(All randomized subjects who take at least one dose of IMP) who have surgical diagnosis.
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| ID | Title | Description |
|---|---|---|
| BG000 | HMI-115 60mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| BG001 | HMI-115 120mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | PAS: All randomized subjects with at least 1 dose with surgical diagnosis | Posted | Least Squares Mean | Standard Error | percentage of change from baseline | Baseline, Week 12 |
|
All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HMI-115 60mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast mass | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ruiping Xiao | Peking University | 86-010-62757243 | xiaor@pku.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2024 | Sep 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2025 | Sep 25, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Drug | Placebo |
|
The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
| Baseline, week 12 and 24 |
| Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | The Numering Rating Score for dyspareunia ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, week 12 and 24 |
| Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The higher scores mean worse outcome. | Baseline, week 12 and 24 |
| Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | Assessment was based on average pill counts at each apecific period od days | Baseline, week 12 and 24 |
| Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | Assessment was based on tampons or pads used. 0 means no bleeding, 4 means heavy bleeding. Higher score means more bleeding. | Baseline, week 12 and 24 |
| Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 24 |
| Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | The Numeric Rating Scale (NRS) for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week12, Week24 |
| Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | The Numering Rating Score(NRS) for dyspareunia(DYSP) ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week12, Week24 |
| Norfolk |
| Virginia |
| 23502 |
| United States |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100703 | China |
| Instytut Matki i Dziecka | Warsaw | Masovian Voivodeship | Poland |
| Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego | Bialystok | Podlaskie Voivodeship | Poland |
| Withdrawal by Subject |
|
| Early Withdrawl |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | HMI-115 240mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| BG003 | Placebo | Once Every 2 weeks, subcutaneously injection Placebo: Placebo |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Endometriosis duration | Mean | Standard Deviation | months |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| DYS NRS | Mean | Standard Deviation | units on a scale |
|
| NMPP NRS | Mean | Standard Deviation | units on a scale |
|
| NSAIDs | Mean | Standard Deviation | pills |
|
| Average Menstrual Bleeding Score | Mean | Standard Deviation | units on a scale |
|
| Monthly Mean Endometriosis Daily Impact Pain Scale | Mean | Standard Deviation | units on a scale |
|
| OG002 | HMI-115 240mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody |
| OG003 | Placebo | Once Every 2 weeks, subcutaneously injection Placebo: Placebo |
|
|
| Primary | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | All randomized subjects with at least 1 dose with surgical diagnosis | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
|
|
|
| Secondary | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | PAS: All randomized subjects who had at least 1 dose with surgical diagnosis | Posted | Least Squares Mean | Standard Error | percentage of change from baseline | Baseline, Week 24 |
|
|
|
| Secondary | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | PAS: All randomized subjects with at least 1 dose with Surgical diagnosis | Posted | Least Squares Mean | Standard Error | percentage of change from baseline | Baseline, week 12 and 24 |
|
|
|
| Secondary | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | The Numering Rating Score for dyspareunia ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | All randomized subjects with at least 1 dose with surgical diagnosis and responsed having sexual intercourse at both baseline and endpoints | Posted | Least Squares Mean | Standard Error | percentage of change from baseline | Baseline, week 12 and 24 |
|
|
|
| Secondary | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The higher scores mean worse outcome. | All randomized subjects with at least 1 dose with surgical diagnosis | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, week 12 and 24 |
|
|
|
| Secondary | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | Assessment was based on average pill counts at each apecific period od days | PAS: All randomized subjects with at least 1 dose with surgical diagnosis | Posted | Mean | Standard Deviation | pill | Baseline, week 12 and 24 |
|
|
|
| Secondary | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | Assessment was based on tampons or pads used. 0 means no bleeding, 4 means heavy bleeding. Higher score means more bleeding. | PAS:All ranomized subjects with at least 1 dose with surgical diagnosis | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 and 24 |
|
|
|
| Secondary | Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | PAS: All randomized subjects with at least 1 dose with surgical diagnosis | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24 |
|
|
|
| Secondary | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | The Numeric Rating Scale (NRS) for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | PAS: All randomized subjects with at least 1 dose with Surgical diagnosis | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week12, Week24 |
|
|
|
| Secondary | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | The Numering Rating Score(NRS) for dyspareunia(DYSP) ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | All randomized subjects with at least 1 dose with surgical diagnosis and responsed having sexual intercourse at both baseline and endpoints | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week12, Week24 |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 15 |
| 27 |
| EG001 | HMI-115 120mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody | 0 | 27 | 0 | 27 | 16 | 27 |
| EG002 | HMI-115 240mg | Once Every 2 weeks, subcutaneously injection HMI-115: HMI-115 is human monoclonal antibody | 0 | 24 | 1 | 24 | 18 | 24 |
| EG003 | Placebo | Once Every 2 weeks, subcutaneously injection Placebo: Placebo | 0 | 30 | 0 | 30 | 11 | 30 |
| Injection site rash | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 3 months from the time submitted to the sponsor for review. If no response from the sponsor in 3 months, it will be treated as the sponsor agrees the publication.
| D000091662 | Genital Diseases |
| Week24 %CFB |
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| Week24 %CFB |
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| Week 24 DYS |
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| Week12 NMPP |
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| Week24 NMPP |
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| Week12 DYSP |
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| Week24 DYSP |
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| CFB Week24 Average pill count Tier1 |
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| CFB Week 24 Average score |
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| Week24 |
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| Week 24 |
|