A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ObsEva SA
- 入组人数
- 328
- 试验地点
- 86
- 主要终点
- Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)
研究概览
简要总结
The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.
详细描述
The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain.
Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen).
Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
- •The subject has moderate to severe endometriosis-associated pain during the screening period.
- •The subject has regular menstrual cycles.
- •The subject has a BMI ≥ 18 kg/m2 at the screening visit.
排除标准
- •The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
- •The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
- •The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
- •The subject has a history of, or known osteoporosis or other metabolic bone disease.
- •The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.
研究组 & 干预措施
OBE2109 50 mg
干预措施: OBE2109 (Drug)
OBE2109 75mg fixed dose (FD)
干预措施: OBE2109 (Drug)
OBE2109 75mg titrated dose (TD)
干预措施: OBE2109 (Drug)
OBE2109 100mg
干预措施: OBE2109 (Drug)
OBE2109 200 mg
干预措施: OBE2109 (Drug)
Placebo / OBE2109 100mg
Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.
干预措施: Placebo (Drug)
Placebo / OBE2109 100mg
Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.
干预措施: OBE2109 (Drug)
结局指标
主要结局
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)
时间窗: From baseline to week 12
The primary efficacy endpoint of the study was a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.
次要结局
- Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With Uterine Bleeding(From baseline to week 12)
- Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS)(From baseline to week 12)
- Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With no Uterine Bleeding(From baseline to week 12)
- Percentage of Subjects With Any Analgesics Use at Week 12(Up to week 12)
- Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD)(From baseline up to week 24)
- Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS)(From baseline to week 12)
- Number of Non Benign Endometrial Biopsies at Week 24(Week 24)
- Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS)(From baseline to week 12)
- Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12(Up to week 12)
- Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL(From baseline up to week 24)
- Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain(From baseline to week 12)
- Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12(Up to week 12)
- Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score(From baseline to week 12)
- Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS)(From baseline up to week 24)
- Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL(From Baseline up to week 24)
- Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides(From baseline up to week 24)