Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06846554

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pulmonary Arterial Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hammersmith/Imperial Hospital, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APL-9796

Drug

3 Cohorts are planned in Part A.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 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

Secondary outcomes

  1. To assess the Telemetry Parameters

    Time frame: from baseline (CFB) to Day 169

    Telemetry parameter is assessed using Total pulmonary resistance (TPR)

  2. To assess the Telemetry Parameters

    Time frame: from baseline (CFB) to Day 169

    Telemetry parameter is assessed using Pulmonary arterial pressures: systolic, diastolic and mean (mPAP)

  3. To assess Six minute walk test / Six minute walk distance (6MWD)

    Time frame: from baseline (CFB) to Day 169

    A 6-minute walk test (6MWT) is assessed per the guidelines of the American Thoracic Society 2003

  4. To assess NT-proB-type Natriuretic Peptide (NT-proBNP)

    Time frame: from baseline (CFB) to Day 169

    The level of NT-proBNP is assessed by blood sample collection and analysis

  5. To assess the Quality of life

    Time frame: from baseline (CFB) to Day 169

    Quality of life is assessed using SF-36 questionnaire

  6. To assess the Quality of life

    Time frame: from baseline (CFB) to Day 169

    Quality of life is assessed using emPHasis-10 questionnaire

  7. 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

    APL-9796 concentrations in serum

  8. 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

    • Incidence of anti-drug antibody (ADA) against APL-9796 (including titres)
    • Incidence of neutralising antibody (Nab) against APL-9796 (including titres)

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjay Aggarwal, MD

CONTACT

[email protected]

781-479-2267

Sponsors and collaborators

Lead sponsor

Apollo Therapeutics Ltd

Industry

Registry information

Official study title

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

Acronym: ViTAL-PH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 26, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.