Recruiting NCT06846554

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

Phase II Interventional Pulmonary Arterial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: APL-9796, APL-9796.
Who it may be relevant to: Registry conditions: Pulmonary Arterial Hypertension. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United Kingdom
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

Drug APL-9796
3 Cohorts are planned in Part A.
Drug 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).

Primary outcome measures

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

Secondary outcome measures (8)

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

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment

Study locations

United Kingdom · 6 centers

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

Identifiers

NCT: NCT06846554 · AP13CP02

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗