RecruitingPhase 2NCT06846554

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

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

Sponsor

Apollo Therapeutics Ltd

Enrollment

48 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria9

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