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Clinical Trials in the UK / NCT06846554
Recruiting Phase 2

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
No
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)

FacilityCityRegionStatus
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

More Apollo Therapeutics Ltd trials in the UK

A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS Recruiting

Other trials for the same condition

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH) Active, not recruiting
An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH) Recruiting
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) Active, not recruiting
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) Recruiting
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) 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