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

NCT06846554 · tracked via the Priya Life Science UK tracker

Sponsor

Apollo Therapeutics Ltd

Phase

Phase 2

Started

2025-04-09

Last updated

2026-05-11

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

APL-9796APL-9796

APL-9796: 3 Cohorts are planned in Part A.

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).

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (6)

Facility	City	Region	Status
Hammersmith/Imperial Hospital	London	London	Recruiting
Royal United Hospital Bath	Bath	United Kingdom	Recruiting
Royal Papworth Hospital	Cambridge	United Kingdom	Recruiting
Golden Jubilee Hospital	Clydebank	United Kingdom	Recruiting
Royal Brompton Hospital	London	United Kingdom	Recruiting
Sheffield Teaching Hospitals	Sheffield	United Kingdom	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06846554 on ClinicalTrials.gov ↗ ← All trials in the UK