NCT06471829招募中2 期
A Phase II, Multi-site, Open-label, Dose-titration Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AG13909 in Adults With Cushing's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 63
- 主要终点
- Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period
研究概览
简要总结
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about
- the effect of Lu AG13909 on cortisol levels.
- the safety and tolerability of Lu AG13909.
- the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).
详细描述
This trial is divided into 3 parts:
- Part A, consisting of 3 periods: an intravenous (IV) Titration Period, a subcutaneous (SC) Period, and a Safety Follow up Period
- Part B, consisting of 3 periods: a SC Titration Period, a Maintenance Period, and a Safety Follow-up Period
- Extension Period, consisting of a Long-Term Efficacy/Safety Period after Part B and a Safety Follow-up Period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current guidelines
- •Morning plasma ACTH levels > lower limit of normal (LLN) and
- •Evidence of a pituitary origin of the excess ACTH:
- •i. Either MRI confirmation of pituitary adenoma >6 millimeters (mm), or ii. inferior petrosal sinus gradient >2, or iii. histopathology confirmation of ACTH-secreting tumour
- •The participant has a 24-hour UFC >1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).
- •Apart from CD and associated well-controlled comorbidities (for example, diabetes mellitus and hypertension), the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the safety laboratory tests.
- •For participants on medical treatment for hypercortisolism due to CD, pre-defined washout periods must be completed prior to the Baseline efficacy assessments.
排除标准
- •The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.
- •The participant has a clinically significant abnormal laboratory value, ECG parameter, vital signs value, or other safety findings at the Screening Visit that indicate a potential risk to the participant's safety if enrolled, in the opinion of the investigator.
- •The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.
- •The participant has immediate need for pituitary surgery within 6 months from screening in the opinion of the investigator.
- •The participant has severe CD per investigator judgement; among others, this could be participants with:
- •i. poorly controlled hypertension ii. poorly controlled diabetes mellitus iii. severe psychiatric illness iv. compression of the optic chiasm causing any visual field defect or risk thereof v. very high risk of thromboembolic events
- •The participant had pituitary surgery <3 month prior to screening.
- •The participant had pituitary radiotherapy within the last 10 years.
- •Other protocol-defined criteria apply.
研究组 & 干预措施
Lu AG13909
Experimental
Participants will first receive Lu AG13909 IV per predefined dosing schedule. Participants will then receive Lu AG13909 SC per predefined dosing schedule.
干预措施: Lu AG13909 (Drug)
结局指标
主要结局
Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period
时间窗: Up to 490 days
次要结局
- AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State(Up to 1037 days)
- CL: Systemic Clearance of Lu AG13909(Up to 1037 days)
- t½: Elimination Half-life of Lu AG13909(Up to 1037 days)
- Vd: Apparent Volume of Distribution of Lu AG13909(Up to 1037 days)
- SC Bioavailability (F) of Lu AG13909(Up to 1037 days)
- Number of Participants With Anti-Drug Antibodies (ADAs)(Up to 1037 days)
- Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909(Up to 323 days)
- Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909(Up to 323 days)
- Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909(Up to 659 days)
- Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough(Up to 659 days)
- UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the End of the IV/SC Titration Period(Up to 491 days)
- Maintenance of UFC Complete Response (mUFC ≤ULN) at the End of the Part B Maintenance Period(Up to 337 days)
- Part A and Part B: Percentage Change from Baseline in mUFC at the End of the Titration Period and the Completion Visit(Baseline, up to 561 days)
- Part A and Part B: UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the Completion Visit(Up to 561 days)
- Part A and Part B: Late Night Salivary Cortisol (LNSC) Complete Response (Mean LNSC (mLNSC)≤ULN) or Partial Response (≥50% Reduction from Baseline in LNSC and mLNSC >ULN) at the End of the Titration Period and the Completion Visit(Up to 561 days)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to 1023 days)
研究者
研究点 (63)
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