NCT07235917招募中2 期
A Phase 2, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 10
- 主要终点
- Change from the highest serum estradiol observed during a 28-day period
研究概览
简要总结
This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on patients with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly.
The aim of the study is to see how well the study drug helps the body make the hormones necessary for ovulation and reproduction, and to assess its safety.
The study is looking at several other research questions, including:
- Whether the drug helps bone health
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea
- •Has had no menstrual bleeding episode within 3 months (or longer) prior to day 1, as described in the protocol
- •Has a Body Mass Index (BMI) ≥18.5 and <25 kg/m^2 at screening, or BMI ≥25 to <30 kg/m^2 at screening AND percentage of body fat <20% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening, as described in the protocol
排除标准
- •Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle)
- •Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening
- •Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian (eg, absence of an ovary, presence of polycystic ovaries) conditions that impact assessment of menses or of the HPO axis
- •Has conditions other than FHA that may cause amenorrhea or menstrual cycle disturbances (eg, polycystic ovarian syndrome, hyperprolactinemia, primary ovarian insufficiency, untreated primary hypothyroidism, primary hyperthyroidism)
- •Polycystic ovarian morphology with an ovarian volume >10 cc on TransVaginal UltraSound (TVUS) [or TransAbdominal Pelvic Ultrasound (TAPU) if applicable] at baseline
- •Presence of follicle ≥17 mm, evidence of ruptured follicle, and/or evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline
- •NOTE: Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Mibavademab
Experimental
干预措施: Mibavademab (Drug)
结局指标
主要结局
Change from the highest serum estradiol observed during a 28-day period
时间窗: Baseline to month 6
次要结局
- Change from the mean serum estradiol observed during a 28-day period(Baseline to month 6)
- Occurrence of menses followed by mid-cycle serum estradiol ≥200 pg/ml and mid-luteal serum progesterone ≥7.9 ng/ml(At month 6)
- Change in the highest serum estradiol(Baseline through 6 months)
- Occurrence of serum estradiol ≥200 pg/ml(Through 6 months)
- Number of ovulatory menstrual cycles(Through 6 months)
- Number of menses with mid-luteal serum progesterone ≥7.9 ng/ml and midluteal estradiol ≥100 pg/ml(Through 6 months)
- Number of menstrual cycles(Through 6 months)
- Percent change in Bone Mineral Density (BMD) at the lumbar spine, as measured by Dual X-ray Absorptiometry (DXA)(Baseline to 6 months)
- Absolute change in BMD at the lumbar spine, as measured by DXA(Baseline to 6 months)
- Percent change in Bone Mineral Content (BMC) at the lumbar spine, as measured by DXA(Baseline to 6 months)
- Absolute change in BMC at the lumbar spine, as measured by DXA(Baseline to 6 months)
- Percent change in BMD at the lumbar spine, as measured by DXA in participants with baseline lumbar spine BMD Z-score <-1(Baseline to 6 months)
- Absolute change in BMD at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score <-1(Baseline to 6 months)
- Percent change in BMC at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score <-1(Baseline to 6 months)
- Absolute change in BMC at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score <-1(Baseline to 6 months)
- Occurrence of Treatment Emergent of Adverse Events (TEAEs)(Up to day 280)
- Severity of TEAEs(Up to day 280)
- Concentrations of total mibavademab in serum(Up to day 280)
- Occurrence of Anti-Drug Antibodies (ADA) to mibavademab(Up to day 280)
- Magnitude of ADA to mibavademab(Up to day 280)
研究者
研究点 (10)
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