Clinical trial NCT05101317: A Study to Assess the Efficacy and Safety of HMI-115 in Subjects with Endometriosis-Associated Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Hope Medicine (Nanjing) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Part 1 of the study will determine the safety and efficacy of HMI 115 at 3 dose levels. Part 2 will detect a higher dose and might be conducted after Part 1.

Eligibility criteria: Inclusion Criteria:

1. Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
2. Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
3. 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.
4. Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

1. Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
2. 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
3. Subject has clinically significant gynecologic condition other than endometriosis
4. 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
5. Subject has history of hysterectomy and/or bilateral oophorectomy
6. Subjects with past or present pituitary tumor growth
7. Subjects has a history of osteoporosis or other metabolic bone disease

Primary outcomes:
measure: Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change in DYS measured by NRS from Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change of non-menstrual pelvic pain (NMPP) measured by NRS from Baseline to Week 12 and 24
timeFrame: Baseline, week 12 and 24
measure: Change in dyspareunia (DYSP) measured by NRS from Baseline to Week 12 and 24
timeFrame: Baseline, week 12 and 24
measure: Change from Baseline (CFB) in the monthly mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
timeFrame: Baseline, week 12 and 24
measure: CFB by visit in permitted rescue medication use
timeFrame: Baseline, week 12 and 24
measure: Change in menstrual period heaviness (bleeding) from Baseline by visit
timeFrame: Baseline, week 12 and 24
Other outcomes:
Locations:
city: Draper
country: United States
facility: Physicians' Research Options, LLC- Corner Canyon Clinic
state: Utah
city: Norfolk
country: United States
facility: Tidewater Clinical Research/TPW
state: Virginia
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Warszawa
country: Poland
facility: Instytut Matki i Dziecka
state: Mazowieckie
city: Bialystok
country: Poland
facility: Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego
state: Podlaskie
Study officials:
References: