An Open-Label Extension Trial of IONIS GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor Administered Monthly Subcutaneously to Patients With Acromegaly Being Treated With Long-Acting Somatostatin Receptor Ligands (SRL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 22
- 主要终点
- The Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of extended dosing with IONIS GHR-LRx in participants with acromegaly as add-on to somatostatin receptor ligands (SRL) therapy.
详细描述
This extension study will include participants up to 60 participants with acromegaly from Study NCT03548415. All participants will remain on the same dose from the previous study and receive IONIS GHR-LRx (SC) injection once every 28 days as add-on to SRL therapy for 53 weeks. At the end of 53 weeks, participants will enter a 14-week post-treatment (PT) evaluation 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomized in index trial (CS2) and completed the entire study, or completion of the treatment period for CS2 and completed or plan to complete PTWK5 visit with an acceptable safety profile, per investigator judgment
- •Participants with confirmed stable monthly regimen of SRL for 3 months prior to screening
- •Able and willing to participate in a 53-week treatment and 14-week post-treatment study
排除标准
- •Treatment with any other acromegaly medications taken prior to Day 1 within the time period: bromocriptine: 2 weeks, carbergoline: 4 weeks, quinagolide: 4 weeks, pegvisomant: 4 weeks and pasireotide: 4 months
- •Participant who received surgery for pituitary adenoma in the last 3 months prior to screening and participants needing and/or planning to receive surgery for the pituitary adenoma during the trial
- •Unwilling to comply with required study procedures during the treatment and post-treatment periods
研究组 & 干预措施
IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)
IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.
干预措施: IONIS GHR-LRx (Drug)
IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)
IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.
干预措施: Somatostatin Receptor Ligand (SRL) (Drug)
结局指标
主要结局
The Incidence of Adverse Events
时间窗: Up to approximately 16 months
Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal
次要结局
- Percentage of Participants who Begin Other Acromegaly Medication(Up to approximately 16 months)
- Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age-Adjusted Upper Limits(Week 26 and at 28 days after the Week 53 dose)
- Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels(Baseline and at Week 26 and Week 53)
- Time From First Dose of IONIS GHR-LRx in this open label extension (CS3) to Date of Initiation of Other Acromegaly Medications(Up to approximately 16 months)
- Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age-Adjusted Upper Limits(Week 26 and at 28 days after the Week 53 dose)