Clinical trial NCT05894135: Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometriosis
Moderate to Severe Endometriosis-associated Pain
Lead sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate the efficacy and safety of BG2109 administered orally once daily at a dose of 100 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, while under randomized treatment, in the management of moderate to severe endometriosis-associated pain (EAP) in chinese women with surgically confirmed endometriosis

Detailed description: This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of BG2109 administered orally once daily at doses of 100 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in chinese women with surgically confirmed endometriosis.

The entire study is divided into the core stage and the extension stage, with a total duration of approximately 72 weeks. This includes the prescreening wash-out period (if applicable), screening period (approximately 5-8 weeks), core stage (24 weeks) and extension stage (28 weeks), and the safety follow-up period (approximately 12 weeks)

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

Primary outcomes:
measure: Dysmenorrhea (DYS) response rate at Week 12
timeFrame: Week 12
measure: Non-menstrual pelvic pain (NMPP) response rate at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change of the interference of pain with the ability to perform daily activities from the baseline at week 24
timeFrame: Week 24
measure: Change of the mean overall pelvic pain(OPP) score from the baseline at week 24
timeFrame: Week 24
measure: Change of the mean DYS score from the baseline at week 24
timeFrame: Week 24
measure: Change of the mean NMPP score from the baseline at week 24
timeFrame: Week 24
measure: Ratio of subjects who do not use analgesics to treat EAP at week 24
timeFrame: Week 24
Other outcomes:
measure: Change of mean pelvic pain scores of DYS from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of mean pelvic pain scores of NMPP from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of mean pelvic pain scores of overall pelvic pain(OPP) from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of mean scores of dyschezia from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of mean scores of dyspareunia from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of the number of days with moderate to severe pelvic pain from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of the number of days with uterine bleeding (including spotting) from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of the number of days of analgesic use (including any class) for EAP from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of the mean worst pelvic pain score defined as the mean of the 5 highest daily pain scores from the baseline to each scheduled assessment
timeFrame: during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
measure: Change of scores in the dimensions of pain, control and powerlessness, emotional well-being, social support, self-image, and sexual relationships from the baseline to each scheduled assessment
timeFrame: during the previous 28 days of Week 4,8,12,24,36,52,56,64
measure: Change of score of quality of life from the baseline to week 24 and week 52
timeFrame: during the previous 28 days of Week 24,52,
measure: Change of uterine size of a patient with concomitant adenomyosis from the baseline to week 12, week 24, and week 52
timeFrame: Week 12,24,52
measure: Change of BMD on lumbar (L1-L4), femoral neck, and total hip from the baseline to week 24 and week 52
timeFrame: Week 24,52
measure: Incidence and severity of treatment emergent adverse events (TEAEs) during treatment period
timeFrame: from first dose to Week 52
measure: Incidence and severity of hypoestrogenic TEAEs (vasomotor symptoms)
timeFrame: from first dose to Week 52
measure: Time to the first post-treatment menses
timeFrame: Week 56 or 64
Locations:
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University
Study officials:
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Congjian Xu
role: PRINCIPAL_INVESTIGATOR
References: