Back to resultsEfficacy and Safety of BG2109 in Chinese Subjects With Endometriosis
Primary Purpose
Endometriosis, Moderate to Severe Endometriosis-associated Pain
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
BG2109 100mg
BG2109 200mg
ABT(E2 1 mg / NETA 0.5 mg)
BG2109 100mg Placebo
BG2109 200mg Placebo
ABT Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Key Inclusion Criteria: The subject must be a premenopausal woman aged ≥18 years. 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. The subject has moderate to severe EAP during the screening period defined as: 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 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; The subject has a Body Mass Index (BMI) ≥ 18 kg/m2 at the screening visit Key Exclusion Criteria: The subject is pregnant or breastfeeding, or plans to become pregnant during the study treatment period. The subject has a surgical history of: Hysterectomy, Bilateral oophorectomy, Surgeries that interfere with gastrointestinal motility, pH value, or absorption (including vagotomy, enterectomy, or gastric surgery), 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. The subject may need to take prohibited medications during the study or in the stipulated time before screening The subject has a contra-indication to ABT 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 The subject has conditions that affect bone mass density (BMD) assessment The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis
Sites / Locations
- Obstetrics & Gynecology Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BG2109 100 mg group
BG2109 200 mg +ABT group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
Dysmenorrhea (DYS) response rate at Week 12
responders are defined as those with a significant decrease in mean DYS score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP
Non-menstrual pelvic pain (NMPP) response rate at Week 12
responders are defined as those with a significant decrease in mean NMPP score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP
Secondary Outcome Measures
Change of the interference of pain with the ability to perform daily activities from the baseline at week 24
measured using the pain dimension in Endometriosis Health Profile-30 (EHP-30)(0-100, higher scores mean worse)
Change of the mean overall pelvic pain(OPP) score from the baseline at week 24
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Change of the mean DYS score from the baseline at week 24
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Change of the mean NMPP score from the baseline at week 24
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Ratio of subjects who do not use analgesics to treat EAP at week 24
Full Information
NCT ID
NCT05894135
First Posted
May 9, 2023
Last Updated
July 25, 2023
Sponsor
Bio Genuine (Shanghai) Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05894135
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Genuine (Shanghai) Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Moderate to Severe Endometriosis-associated Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BG2109 100 mg group
Arm Type
Experimental
Arm Title
BG2109 200 mg +ABT group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BG2109 100mg
Intervention Description
One tablet of BG2109 100mg , oral , once daily
Intervention Type
Drug
Intervention Name(s)
BG2109 200mg
Intervention Description
One tablet of BG2109 200mg, oral , once daily.
Intervention Type
Drug
Intervention Name(s)
ABT(E2 1 mg / NETA 0.5 mg)
Intervention Description
One tablet of ABT(E2 1 mg / NETA 0.5 mg), oral, once-daily
Intervention Type
Drug
Intervention Name(s)
BG2109 100mg Placebo
Intervention Description
One tablet of BG2109 100mg Placebo, oral , once daily.
Intervention Type
Drug
Intervention Name(s)
BG2109 200mg Placebo
Intervention Description
One tablet of BG2109 200mg Placebo, oral , once daily.
Intervention Type
Drug
Intervention Name(s)
ABT Placebo
Intervention Description
One tablet of ABT Placebo, oral, once-daily
Primary Outcome Measure Information:
Title
Dysmenorrhea (DYS) response rate at Week 12
Description
responders are defined as those with a significant decrease in mean DYS score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP
Time Frame
Week 12
Title
Non-menstrual pelvic pain (NMPP) response rate at Week 12
Description
responders are defined as those with a significant decrease in mean NMPP score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change of the interference of pain with the ability to perform daily activities from the baseline at week 24
Description
measured using the pain dimension in Endometriosis Health Profile-30 (EHP-30)(0-100, higher scores mean worse)
Time Frame
Week 24
Title
Change of the mean overall pelvic pain(OPP) score from the baseline at week 24
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
Week 24
Title
Change of the mean DYS score from the baseline at week 24
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
Week 24
Title
Change of the mean NMPP score from the baseline at week 24
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
Week 24
Title
Ratio of subjects who do not use analgesics to treat EAP at week 24
Time Frame
Week 24
Other Pre-specified Outcome Measures:
Title
Change of mean pelvic pain scores of DYS from the baseline to each scheduled assessment
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
Change of mean pelvic pain scores of NMPP from the baseline to each scheduled assessment
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
Change of mean pelvic pain scores of overall pelvic pain(OPP) from the baseline to each scheduled assessment
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
Change of mean scores of dyschezia from the baseline to each scheduled assessment
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
Change of mean scores of dyspareunia from the baseline to each scheduled assessment
Description
measured using Verbal rating scale - VRS(0-3, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
Change of the number of days with moderate to severe pelvic pain from the baseline to each scheduled assessment
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
Change of the number of days with uterine bleeding (including spotting) from the baseline to each scheduled assessment
Description
measured using the uterine bleeding scale(0-3, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
Change of the number of days of analgesic use (including any class) for EAP from the baseline to each scheduled assessment
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
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
Description
measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse)
Time Frame
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Title
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
Description
measured using the EHP-30 core questionnaire（contains 5 dimensions：pain, control and powerlessness, emotional well-being, social support, self-image; all are 0-100 score, higher scores mean worse） and Module C（0-100 score, higher scores mean worse）
Time Frame
during the previous 28 days of Week 4,8,12,24,36,52,56,64
Title
Change of score of quality of life from the baseline to week 24 and week 52
Description
measured using SF-36v2 ® Health Survey (SF-36v2)（0-100 score, higher scores mean better ）
Time Frame
during the previous 28 days of Week 24,52,
Title
Change of uterine size of a patient with concomitant adenomyosis from the baseline to week 12, week 24, and week 52
Time Frame
Week 12,24,52
Title
Change of BMD on lumbar (L1-L4), femoral neck, and total hip from the baseline to week 24 and week 52
Description
measured using dual-energy x-ray absorptiometry (DXA)
Time Frame
Week 24,52
Title
Incidence and severity of treatment emergent adverse events (TEAEs) during treatment period
Time Frame
from first dose to Week 52
Title
Incidence and severity of hypoestrogenic TEAEs (vasomotor symptoms)
Time Frame
from first dose to Week 52
Title
Time to the first post-treatment menses
Time Frame
Week 56 or 64
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
The subject must be a premenopausal woman aged ≥18 years.
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.
The subject has moderate to severe EAP during the screening period defined as:
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
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;
The subject has a Body Mass Index (BMI) ≥ 18 kg/m2 at the screening visit
Key Exclusion Criteria:
The subject is pregnant or breastfeeding, or plans to become pregnant during the study treatment period.
The subject has a surgical history of:
Hysterectomy,
Bilateral oophorectomy,
Surgeries that interfere with gastrointestinal motility, pH value, or absorption (including vagotomy, enterectomy, or gastric surgery),
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.
The subject may need to take prohibited medications during the study or in the stipulated time before screening
The subject has a contra-indication to ABT
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
The subject has conditions that affect bone mass density (BMD) assessment
The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Kong
Phone
021-58590032
Email
Kevin.Kong@Bio-Genuine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Congjian Xu
Organizational Affiliation
Obstetrics & Gynecology Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetrics & Gynecology Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Congjian Xu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis
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