Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

NCT05894135 | Unknown Phase 3

• 1 other identifier: BG2109-AB-301
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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

Conditions

Endometriosis; Moderate to Severe Endometriosis-associated Pain

Outcome Measures

Primary Outcomes (2)

• 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

  Week 12

• 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

  Week 12

Secondary Outcomes (5)

• Change of the interference of pain with the ability to perform daily activities from the baseline at week 24

  Week 24

• Change of the mean overall pelvic pain(OPP) score from the baseline at week 24

  Week 24

• Change of the mean DYS score from the baseline at week 24

  Week 24

• Change of the mean NMPP score from the baseline at week 24

  Week 24

• Ratio of subjects who do not use analgesics to treat EAP at week 24

  Week 24

Other Outcomes (16)

• Change of mean pelvic pain scores of DYS from the baseline to each scheduled assessment

  during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64

• Change of mean pelvic pain scores of NMPP from the baseline to each scheduled assessment

  during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64

• Change of mean pelvic pain scores of overall pelvic pain(OPP) from the baseline to each scheduled assessment

  during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64

Study Arms (3)

BG2109 100 mg group

EXPERIMENTAL

Drug: BG2109 100mg; Drug: BG2109 200mg Placebo; Drug: ABT Placebo

BG2109 200 mg +ABT group

EXPERIMENTAL

Drug: BG2109 200mg; Drug: ABT(E2 1 mg / NETA 0.5 mg); Drug: BG2109 100mg Placebo

Placebo group

PLACEBO COMPARATOR

Drug: BG2109 100mg Placebo; Drug: BG2109 200mg Placebo; Drug: ABT Placebo

Interventions

BG2109 100mg DRUG

One tablet of BG2109 100mg , oral , once daily

BG2109 100 mg group

BG2109 200mg DRUG

One tablet of BG2109 200mg, oral , once daily.

BG2109 200 mg +ABT group

ABT(E2 1 mg / NETA 0.5 mg) DRUG

One tablet of ABT(E2 1 mg / NETA 0.5 mg), oral, once-daily

BG2109 200 mg +ABT group

BG2109 100mg Placebo DRUG

One tablet of BG2109 100mg Placebo, oral , once daily.

BG2109 200 mg +ABT group; Placebo group

BG2109 200mg Placebo DRUG

One tablet of BG2109 200mg Placebo, oral , once daily.

BG2109 100 mg group; Placebo group

ABT Placebo DRUG

One tablet of ABT Placebo, oral, once-daily

BG2109 100 mg group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio Genuine (Shanghai) Biotech Co., Ltd.: lead

Study Sites (1)

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Congjian Xu

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Kong

CONTACT

021-58590032; Kevin.Kong@Bio-Genuine.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 8, 2023
• Study Start: July 14, 2023
• Primary Completion: June 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)