EndometriosisPhase 2NCT05101317
A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain
A Phase 2 study testing HMI-115 in people with Endometriosis, run by Hope Medicine (Nanjing) Co., Ltd at 5 sites in 3 countries.
Trial summary
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. 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
- 142 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 11 Oct 2021to 19 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
- Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
- Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 with a score of at least 2 for DYS and at least 2 for NMPP at screening.
- Subject agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
- Subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain
- Subject has clinically significant gynecologic condition other than endometriosis
- 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 has history of hysterectomy and/or bilateral oophorectomy
- Subjects with past or present pituitary tumor growth
- Subjects has a history of osteoporosis or other metabolic bone disease
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Physicians' Research Options, LLC- Corner Canyon Clinic
Draper, Utah, 84020
Tidewater Clinical Research/TPW
Norfolk, Virginia, 23502
Poland2 sites
Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego
Bialystok, Podlaskie Voivodeship
Instytut Matki i Dziecka
Warsaw, Masovian Voivodeship
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100703
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period
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.
Read the detailed description
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.
- 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
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HMI-115 60mg | Experimental | Once Every 2 weeks, subcutaneously injection Receives: Drug: HMI-115 |
| HMI-115 120mg | Experimental | Once Every 2 weeks, subcutaneously injection Receives: Drug: HMI-115 |
| HMI-115 240mg | Experimental | Once Every 2 weeks, subcutaneously injection Receives: Drug: HMI-115 |
| Placebo | Placebo comparator | Once Every 2 weeks, subcutaneously injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 12
Secondary outcomes (9)
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.
Measured: 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)
The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week12, Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start11 Oct 2021
- Primary completion26 Sep 2024
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
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
- NCT05101317
- Sponsor's protocol ID
- HMI-115EM201
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2021
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period
- ClinicalTrials.gov ID
- NCT05101317
- Acronym / sponsor ID
- HMI-115EM201
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hope Medicine (Nanjing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HMI-115 60mg | Experimental | Drug: HMI-115Once Every 2 weeks, subcutaneously injection |
| HMI-115 120mg | Experimental | Drug: HMI-115Once Every 2 weeks, subcutaneously injection |
| HMI-115 240mg | Experimental | Drug: HMI-115Once Every 2 weeks, subcutaneously injection |
| Placebo | Placebo comparator | Drug: PlaceboOnce Every 2 weeks, subcutaneously injection |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
- Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
- Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 with a score of at least 2 for DYS and at least 2 for NMPP at screening.
- Subject agrees not to participate in another interventional study while participating in the present study.
Key exclusion criteria (7 listed)
- Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
- Subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain
- Subject has clinically significant gynecologic condition other than endometriosis
- 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 has 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 | Drug | HMI-115 120mg, HMI-115 240mg, HMI-115 60mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)
Time frame: Baseline, Week 12
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change）
Time frame: Baseline, Week 12
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
9 secondary outcomes
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)
Time frame: 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)
Time frame: Baseline, week 12 and 24
Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change)
Time frame: Baseline, week 12 and 24
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Time frame: Baseline, week 12 and 24
Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use
Time frame: Baseline, week 12 and 24
Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit
Time frame: Baseline, week 12 and 24
Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change)
Time frame: 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)
Time frame: Baseline, Week12, Week24
Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
Time frame: Baseline, Week12, Week24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
RecruitingPhase 4
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Ovarian Endometrioma, Endometrioma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HMI-115 in people with Endometriosis, run by Hope Medicine (Nanjing) Co., Ltd at 5 sites in 3 countries.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 21 Jan 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 United States, Poland, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) (time frame: Baseline, 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 21 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.