HMI-115 for Endometriosis Pain

No longer recruiting at 12 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Hope Medicine (Nanjing) Co., Ltd

Must not be taking: Opioids, NSAIDs

Disqualifiers: Pregnancy, Chronic pain, Gynecologic conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HMI-115 to determine if it can safely and effectively reduce pain caused by endometriosis over 12 weeks. The study compares different doses of the treatment against a placebo, meaning some participants will receive injections without the active drug. Women diagnosed with endometriosis who experience moderate to severe pain may be suitable for this trial. Participants will receive injections every two weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HMI-115 is generally safe and well-tolerated. In a previous study with 102 patients, no serious side effects were directly linked to the treatment. This suggests that the treatment is safe for most people. However, like any treatment, some minor side effects might occur. These findings encourage those considering joining the trial, as they indicate a good safety profile for HMI-115. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometriosis?

Most treatments for endometriosis, like hormonal therapies and pain relievers, aim to manage symptoms by altering hormone levels or reducing inflammation. HMI-115 stands out because it targets a different mechanism: it uses a monoclonal antibody approach to tackle the condition. This treatment is administered via subcutaneous injection every two weeks, offering a potentially more precise method of addressing endometriosis pain. Researchers are excited about HMI-115 because it could provide relief with fewer hormonal side effects and a more targeted impact on the disease process.

What evidence suggests that HMI-115 might be an effective treatment for endometriosis pain?

Research has shown that HMI-115, which participants in this trial may receive, may help reduce pain from endometriosis. In earlier studies, patients reported a 42% decrease in pain during their periods. This suggests that HMI-115 could effectively relieve moderate to severe endometriosis pain. These findings support considering HMI-115 as a possible treatment for pain caused by endometriosis. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women aged 18-49 with a documented diagnosis of endometriosis and moderate to severe pain. They must not be pregnant, planning pregnancy, or breastfeeding, and should have no history of hysterectomy, oophorectomy, osteoporosis, other chronic pain conditions that could affect the study's outcome.

Inclusion Criteria

I am a woman aged 18-49 and have not gone through menopause.

I experience significant pelvic pain and menstrual pain.

Subject agrees not to participate in another interventional study while participating in the present study

Exclusion Criteria

I have a serious gynecological condition that is not endometriosis.

My chronic pelvic pain is not due to endometriosis or any other chronic pain condition.

I have had severe reactions to opioids or NSAIDs, or I can't use them due to stomach issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HMI-115 or placebo subcutaneously every 2 weeks for 12 weeks

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HMI-115
• Placebo

Trial Overview The trial tests HMI-115 against a placebo over 12 weeks to see if it can safely reduce pain associated with endometriosis. Participants will randomly receive either the drug or placebo without knowing which one they are taking.

How Is the Trial Designed?

Group I: HMI-115 60mg Active Control 1 Intervention

Once Every 2 weeks, subcutaneously injection

Group II: HMI-115 120mg Active Control 1 Intervention

Once Every 2 weeks, subcutaneously injection

Group III: HMI-115 240mg Active Control 1 Intervention

Once Every 2 weeks, subcutaneously injection

Group IV: Placebo Placebo Group 1 Intervention

Once Every 2 weeks, subcutaneously injection

Who Is Running the Clinical Trial?

Hope Medicine (Nanjing) Co., Ltd

Lead Sponsor

Trials

3

Recruited

350+

Published Research Related to This Trial

A network meta-analysis of 36 randomized controlled trials involving 7942 patients found that dienogest, combined hormonal contraceptives (CHCs), and elagolix were the most effective treatments for reducing pelvic pain related to endometriosis at three months.

Gonadotropin-releasing hormone (GnRH) analogues were ranked highest for reducing dysmenorrhea at three months and CHCs at six months, indicating that these treatments are effective options for managing various types of endometriosis-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical therapy options for endometriosis related pain, which is better? A systematic review and network meta-analysis of randomized controlled trials. Samy, A., Taher, A., Sileem, SA., et al.[2021]

The ENDOPAIN-4D questionnaire, validated in a study of 199 women with endometriosis, effectively measures pain-related symptoms across four dimensions, demonstrating good internal consistency and sensitivity to change after treatment.

It has a minimal clinically important difference of 10.9, making it a reliable tool for assessing treatment outcomes and patient follow-up in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis. Puchar, A., Panel, P., Oppenheimer, A., et al.[2021]

Depot medroxyprogesterone acetate (DMPA-SC 104) is as effective as leuprolide in reducing endometriosis-associated pain over an 18-month period, with significant improvements in multiple pain categories.

DMPA-SC 104 causes significantly less decline in bone mineral density compared to leuprolide, and BMD levels return to pre-treatment levels 12 months after stopping DMPA-SC 104, indicating a safer profile for bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. Crosignani, PG., Luciano, A., Ray, A., et al.[2022]

A systematic review of 58 articles involving women treated for endometriosis-associated pain revealed that 11%-19% of patients experienced no reduction in pain, and 5%-59% still had pain at the end of treatment.

Despite some benefits, many women only experienced limited or intermittent relief from symptoms, with 17%-34% experiencing pain recurrence after treatment cessation, highlighting the need for better reporting of patient-relevant outcomes in studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reevaluating response and failure of medical treatment of endometriosis: a systematic review. Becker, CM., Gattrell, WT., Gude, K., et al.[2022]

In a study of 373 women with endometriosis, worse chronic pelvic pain (CPP) severity and pelvic floor myalgia were linked to the ineffectiveness of continuous combined hormonal contraception (CHC), suggesting that these factors may hinder the treatment's success.

Women who discontinued CHC due to side effects reported poorer quality of life, highlighting the need for further research to address these side effects and improve treatment outcomes for patients with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHC for pelvic pain in women with endometriosis: ineffectiveness or discontinuation due to side-effects. Yong, PJ., Alsowayan, N., Noga, H., et al.[2022]

Citations

1. hopemedinc.com hopemedinc.com/company-release-40

Hope Medicine Inc. Announces Positive Results from a ... HMI-115 has demonstrated statistically significant improvement in endometriosis pain. The mean dysmenorrhea pain score was reduced by 42%.

2. biospace.com biospace.com/press-releases/hope-medicine-inc-announces-successful-completion-of-a-global-phase-2-study-of-a-potential-first-in-class-endometriosis-treatment

Hope Medicine Inc. Announces Successful Completion of a ... HMI-115 demonstrated statistically significant improvement in endometriosis pain. The mean dysmenorrhea pain score was reduced by 42%.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/17/NCT05101317/Prot_000.pdf

A Randomized, Multicenter, Double-Blind, Placebo- ... This study aims to evaluate the safety and efficacy of HMI-115 versus a placebo in pre-menopausal women aged 18 to 49 years diagnosed with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05101317?tab=history&a=3

Record History | ver. 3: 2022-03-26 | NCT05101317 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.

5. finance.yahoo.com finance.yahoo.com/news/hope-medicine-inc-announces-successful-010800414.html

Hope Medicine Inc. Announces Successful Completion of a ... HMI-115 demonstrated statistically significant improvement in endometriosis pain. The mean dysmenorrhea pain score was reduced by 42%.

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05101317/

Trial | NCT05101317 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.

7. withpower.com withpower.com/trial/phase-3-endometriosis-9-2021-e28e6

HMI-115 for Endometriosis Pain · Info for Participants This trial is testing HMI-115, a new treatment for reducing pain from endometriosis. It focuses on pre-menopausal women who have moderate to severe pain.