A Trial of "APL-9796'' in Adults With Pulmonary Hypertension (ViTAL-PH)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: APL-9796; Drug: APL-9796

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sanjay Aggarwal, MD; Phone Number: 781-479-2267; Email: AP13@apollotx.com

Study Locations

• United Kingdom
  • Bath, United Kingdom
    • Recruiting
    • Royal United Hospital Bath
  • Cambridge, United Kingdom
    • Recruiting
    • Royal Papworth Hospital
  • Clydebank, United Kingdom
    • Recruiting
    • Golden Jubilee Hospital
  • London, United Kingdom
    • Recruiting
    • Royal Brompton Hospital
  • Sheffield, United Kingdom
    • Recruiting
    • Sheffield Teaching Hospitals
  • London
    • London, London, United Kingdom, W12 0HS
      • Recruiting
      • Hammersmith/Imperial Hospital
      • Contact: Luke Howard, Professor; Phone Number: +44 20 3313 3171; Email: l.howard@imperial.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant must be 18 to 80 years of age inclusive
2. Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.
3. WHO Functional Class II or III
4. Participant has the CardioMEMS PA Sensor implanted.

Exclusion Criteria:

1. Hospital admission related to PH within 3 months prior to Screening.
2. Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator
3. Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
4. History of left-sided heart disease and/or clinically significant cardiac disease
5. History of uncontrolled systemic hypertension
6. eGFR ≤30 ml/min/1.73m2
7. Life expectancy of < 12 months, as assessed by the Investigator
8. Diagnosed with a malignancy within 5 years of enrolment
9. Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: in adults with WHO Group 1 PAH.; Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.	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).
Experimental: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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	Through study completion (approximately 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the Telemetry Parameters	Telemetry parameter is assessed using Total pulmonary resistance (TPR)	from baseline (CFB) to Day 169
To assess the Telemetry Parameters	Telemetry parameter is assessed using Pulmonary arterial pressures: systolic, diastolic and mean (mPAP)	from baseline (CFB) to Day 169
To assess Six minute walk test / Six minute walk distance (6MWD)	A 6-minute walk test (6MWT) is assessed per the guidelines of the American Thoracic Society 2003	from baseline (CFB) to Day 169
To assess NT-proB-type Natriuretic Peptide (NT-proBNP)	The level of NT-proBNP is assessed by blood sample collection and analysis	from baseline (CFB) to Day 169
To assess the Quality of life	Quality of life is assessed using SF-36 questionnaire	from baseline (CFB) to Day 169
To assess the Quality of life	Quality of life is assessed using emPHasis-10 questionnaire	from baseline (CFB) to Day 169
To evaluate the PK of APL-9796 in participants with PH	APL-9796 concentrations in serum	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.	Incidence of anti-drug antibody (ADA) against APL-9796 (including titres); Incidence of neutralising antibody (Nab) against APL-9796 (including titres)	at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508

Collaborators and Investigators

• Sponsor: Apollo Therapeutics Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; WHO group 3; WHO group 1 PH
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: AP13CP02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No