Testing BG2109 for treating endometriosis pain in Chinese women

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

This study is testing if a new oral medication called BG2109 can help Chinese women with moderate to severe endometriosis pain feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05894135 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of BG2109, administered orally once daily, in managing moderate to severe endometriosis-associated pain in Chinese women with surgically confirmed endometriosis. Participants will be randomly assigned to receive either BG2109 at doses of 100 mg or 200 mg, with some receiving hormone replacement therapy, while others will receive a placebo. The study consists of a core stage lasting 24 weeks followed by a 28-week extension stage, with a total duration of approximately 72 weeks including screening and safety follow-up periods.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 18 and older with a recent surgical diagnosis of moderate to severe endometriosis-associated pain.

Not a fit: Patients who do not have a confirmed diagnosis of endometriosis or those who are postmenopausal may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain associated with endometriosis, improving the quality of life for affected patients.

How similar studies have performed: While this approach is being tested in this specific population, similar studies have shown promise in managing endometriosis pain with other treatments.

Eligibility criteria

Key Inclusion Criteria:

1. The subject must be a premenopausal woman aged ≥18 years.
2. The subject must have had her most recent surgical and histological diagnosis of pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix or other biopsy) within 10 years and at least 2 months ago prior to screening.
3. The subject has moderate to severe EAP during the screening period defined as:

   1. At the screening visit, a score of at least 2 for DYS and at least 2 for NMPP for the previous month assessed with the modified Biberoglu \& Behrman (mB\&B) scale
   2. Subject is confirmed to meet the following criteria during the screening period, within 35 consecutive calendar days prior to the baseline visit:

   i. Mean overall pelvic pain scores on the 0-10 NRS over the 5 days with the highest score ≥ 4; ii. At least two days with "moderate" or "severe" pain on the 0-3 VRS for pelvic pain over the days with uterine bleeding; iii. At least two days with "moderate" or "severe" pain on the 0-3 VRS for pelvic pain over the days without uterine bleeding;
4. The subject has a Body Mass Index (BMI) ≥ 18 kg/m2 at the screening visit

Key Exclusion Criteria:

1. The subject is pregnant or breastfeeding, or plans to become pregnant during the study treatment period.
2. The subject has a surgical history of:

   1. Hysterectomy,
   2. Bilateral oophorectomy,
   3. Surgeries that interfere with gastrointestinal motility, pH value, or absorption (including vagotomy, enterectomy, or gastric surgery),
   4. Any major abdominal surgery (including laparotomy for endometriosis) within 6 months or any interventional surgery for endometriosis (i.e. laparoscopy) performed within a period of 2 months before screening, or the subject is scheduled for a surgical abdominal procedure during the course of the study.
3. The subject may need to take prohibited medications during the study or in the stipulated time before screening
4. The subject has a contra-indication to ABT
5. The subject has chronic pelvic pain that, in the opinion of the Investigator, is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of EAP
6. The subject has conditions that affect bone mass density (BMD) assessment
7. The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis

Where this trial is running

Shanghai

• Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Congjian Xu — Obstetrics & Gynecology Hospital of Fudan University
• Study coordinator: Kevin Kong

Conditions Endometriosis; Moderate to Severe Endometriosis-associated Pain