NCT07037420终止2 期
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination With Somatostatin Analogs in Adult Participants With Acromegaly
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 51
- 主要终点
- Percentage Change From Baseline in Serum IGF-1 Level at Week 15
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog (SSA) therapy to adult participants with acromegaly.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
- •Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanreotide LAR) and meet both of the following:
- •Received for ≥ 6 months prior to screening
- •Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6 weeks) are not eligible
- •Must be a partial responder to SSAs defined as > 20% relative IGF 1 reduction during the course of SSA therapy
- •Serum IGF-1 levels > 1.3 to 5*ULN inclusive, as assessed at a central laboratory and adjusted for age and sex, based on average of 2 consecutive values obtained during the Screening Period and obtained ≥ 7 days apart
排除标准
- •Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study
- •Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months prior to screening
- •Pituitary adenoma causing compression of the chiasm
- •Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists
- •Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3 months prior to Screening
- •Active, clinically significant cardiac disease as judged by the Investigator
- •History of unstable angina, stroke, or acute myocardial infarction ≤ 3 months prior to screening
- •Known uncontrolled type 2 diabetes (HbA1c > 10%)
- •Active malignant disease ≤ 2 years prior to screening with exception of basal and squamous cell carcinoma of the skin
- •Received any type of fractionated radiotherapy or a second surgical adenectomy for pituitary adenoma within the last 3 years (5 years for conventional radiation) before starting treatment and/or are planning to receive radiotherapy or a second surgical adenectomy during the study
- •Received pegvisomant ≤ 8 weeks prior to screening
- •Received dopamine agonists ≤ 4 weeks prior to screening
- •Received pasireotide LAR ≤ 4 months prior to screening
- •Clinically significant renal or hepatic disease at the time of screening, as judged by the Investigator
- •eGFR (CKD-EPI formula) < 30 mL/minute/1.73 m^2 documented based on recent value (< 3 months prior to randomization)
- •Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis, as judged by the Investigator, including, but not limited to, total bilirubin > 1.5*ULN (except if in free bilirubin linked to a known Gilbert Syndrome) or AST, ALT, or alkaline phosphatase > 2*ULN
研究组 & 干预措施
Placebo
Placebo Comparator
During the Primary Evaluation Period, participants will receive the first dose of placebo via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks.
干预措施: Placebo (Drug)
Open-label Extension Period
Experimental
During the Open-label Extension (OLE) Period, participants in the ALXN2420 treatment groups will continue receiving ALXN2420 treatment and participants in the placebo groups will crossover to receive ALXN2420 at Week 15. At the Week 15 Visit, the dose level and the dosing regimen of ALXN2420 will be determined for each participant based on the Week 13 IGF-1 level. The OLE Period assessments will be performed at Weeks 19, 26, 32, 39, 45, and 52.
干预措施: ALXN2420 (Drug)
ALXN2420
Experimental
During the Primary Evaluation Period, participants will receive the first dose of ALXN2420 via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks.
干预措施: ALXN2420 (Drug)
结局指标
主要结局
Percentage Change From Baseline in Serum IGF-1 Level at Week 15
时间窗: Baseline, Week 15
次要结局
- Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15(Week 15)
- Number of Participants Who Achieve of Serum IGF-1 Level ≤1.0 ULN at Week 15(Week 15)
- Change from Basline in Symptoms as assessed by disease specific questionnaire, at Week 15(Baseline, Week 15)
- Change From Baseline in Serum IGF-1 Level at Week 15(Baseline, Week 15)
- Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15(Baseline, Week 15)
- Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15(Baseline, Week 15)
- Change From Baseline in Acromegaly Quality of Life (AcroQoL) at Week 15(Baseline, Week 15)
- Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale(Baseline, Week 15)
- Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale(Week 15)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Study Intervention Discontinuation or Interruption(Baseline (Day 1) through Week 15)
- Plasma Concentration of ALXN2420(Baseline (Day 1) through Week 15)
- Number of Participants With Antidrug Antibodies (ADAs)(Baseline (Day 1) through Week 15)
研究者
研究点 (51)
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