A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
The AP13CP02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (SC) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796.
The trial will be conducted in two parts:
- Part A: Up to 36 adults with WHO Group 1 Pulmonary arterial hypertension (PAH).
- Part B (optional): Up to 12 adults with WHO Group 3 - PH associated with ILD (PH-ILD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Participant must be 18 to 80 years of age inclusive
- •Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.
- •WHO Functional Class II or III
- •Participant has the CardioMEMS PA Sensor implanted.
排除标准
- •Hospital admission related to PH within 3 months prior to Screening.
- •Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator
- •Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
- •History of left-sided heart disease and/or clinically significant cardiac disease
- •History of uncontrolled systemic hypertension
- •eGFR ≤30 ml/min/1.73m2
- •Life expectancy of < 12 months, as assessed by the Investigator
- •Diagnosed with a malignancy within 5 years of enrolment
- •Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods
研究组 & 干预措施
Part A: in adults with WHO Group 1 PAH.
Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.
干预措施: APL-9796 (Drug)
Part B (optional): in adults with WHO Group 3 PH-ILD
Cohorts will be enrolled sequentially at N=4, at a dose level determined by the Safety Review Committee (SRC) based on data from Part A.
干预措施: APL-9796 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Through study completion (approximately 2 years)
Number of participants who experience Treatment-Emergent Adverse Events will be reported which also include the frequency, severity (CTCAE V5.0) and relationship (causality) of AEs
次要结局
- To assess Six minute walk test / Six minute walk distance (6MWD)(from baseline (CFB) to Day 169)
- To assess NT-proB-type Natriuretic Peptide (NT-proBNP)(from baseline (CFB) to Day 169)
- To evaluate the PK of APL-9796 in participants with PH(at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508)
- To evaluate the immunogenicity of APL-9796 in participants with PH.(at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508)
- To assess the Quality of life(from baseline (CFB) to Day 169)
- To assess the Telemetry Parameters(from baseline (CFB) to Day 169)