A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Recruiting · NCT06846554 · Interventional (participants receive a specific treatment) · Lead sponsor: Apollo Therapeutics Ltd
View the official record on ClinicalTrials.gov →Interventions studied
APL-9796
What this trial is about
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).
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
6 locations listed.
- Royal United Hospital Bath - Bath, United Kingdom
- Royal Papworth Hospital - Cambridge, United Kingdom
- Golden Jubilee Hospital - Clydebank, United Kingdom
- Royal Brompton Hospital - London, United Kingdom
- Sheffield Teaching Hospitals - Sheffield, United Kingdom
- Hammersmith/Imperial Hospital - London, London, United Kingdom