A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 119
- 试验地点
- 114
- 主要终点
- Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN
研究概览
简要总结
The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
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
- Double (Participant, Care Provider)
盲法说明
Arms A and B: Period 1 (Double-blind) and Period 2 (Open-label). Arm C: Open-label.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age
- •Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
- •IGF-1 at screening ≤1x ULN
- •Acromegaly diagnosis, defined as per protocol
- •Adequate bone marrow, hepatic and renal function
- •To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication
- •Other protocol-defined criteria apply
排除标准
- •Compression of optic chiasm causing visual defects
- •Symptomatic cholelithiasis or bile duct dilatation
- •Planned cholecystectomy during the trial duration
- •Acute or chronic pancreatitis
- •Pituitary radiotherapy
- •Uncontrolled hypothyroidism
- •Uncontrolled diabetes
- •Pituitary surgery within 6 months before screening or planned on trial
- •Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening
- •Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
- •Other protocol-defined criteria apply
研究组 & 干预措施
Arm B: Placebo + Debio 4126
During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.
Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 >1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
干预措施: Debio 4126 (Drug)
Arm C: Debio 4126 (Open-Label Treatment Period)
During the Treatment Period, participants will receive an IM injection of Debio 4126 once every 12 weeks over a total of between 60 and 96 weeks (between 5 and 8 injections in total).
干预措施: Debio 4126 (Drug)
Arm B: Placebo + Debio 4126
During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.
Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 >1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
干预措施: Placebo (Drug)
Arm A: Debio 4126
During Period 1 (double-blind treatment period), participants will receive an intramuscular (IM) injection of Debio 4126 once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.
Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 >1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
干预措施: Debio 4126 (Drug)
结局指标
主要结局
Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN
时间窗: 36 Weeks
次要结局
- Arm C: Percentage of Participants With IGF-1 ≤1x ULN(36 Weeks)
- Percent Change From Baseline in IGF-1 Values(Up to 108 Weeks)
- Percentage of Participants With IGF-1 ≤1x ULN(Up to 108 Weeks)
- Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL(Up to 108 Weeks)
- Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)(Up to 36 Weeks)
- Percentage of Participants Who Experienced at Least One TEAE(Up to 113 Weeks)
- Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment(Up to 108 Weeks)
- Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score(Up to 108 Weeks)
- Double-blind Period: Percentage of Participants Taking Rescue Medication(Up to 36 Weeks)
- Trough Plasma Concentration (Ctrough) of Debio 4126(Up to 96 Weeks)