A Trial of "APL-9796'' in Adults With Pulmonary Hypertension

Официальное название

A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)

Обзор

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).

Вмешательства

• Препарат APL-9796
  3 Cohorts are planned in Part A.
• Препарат APL-9796
  The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: Through study completion (approximately 2 years)]

Вторичные конечные точки (8)

• To assess the Telemetry Parameters [Срок оценки: from baseline (CFB) to Day 169]
• To assess the Telemetry Parameters [Срок оценки: from baseline (CFB) to Day 169]
• To assess Six minute walk test / Six minute walk distance (6MWD) [Срок оценки: from baseline (CFB) to Day 169]
• To assess NT-proB-type Natriuretic Peptide (NT-proBNP) [Срок оценки: from baseline (CFB) to Day 169]
• To assess the Quality of life [Срок оценки: from baseline (CFB) to Day 169]
• To assess the Quality of life [Срок оценки: from baseline (CFB) to Day 169]
• To evaluate the PK of APL-9796 in participants with PH [Срок оценки: 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. [Срок оценки: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 6 центров

• Hammersmith/Imperial Hospital — London
• Royal United Hospital Bath — Bath
• Royal Papworth Hospital — Cambridge
• Golden Jubilee Hospital — Clydebank
• Royal Brompton Hospital — London
• Sheffield Teaching Hospitals — Sheffield

Идентификаторы

NCT: NCT06846554 · AP13CP02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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