Tests APL-9796 injections in adults with pulmonary hypertension
Tests APL-9796 injections for safety and tolerability in adults with pulmonary hypertension.
Plain-language title generated from the registry record
Registry title: A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Key facts
- Where
- Bath, Cambridge, Clydebank, London, and Sheffield, United KingdomSee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06846554, who can take part
Where in United Kingdom
- Royal United Hospital BathBath, United KingdomTaking people
- Royal Papworth HospitalCambridge, United KingdomTaking people
- Golden Jubilee HospitalClydebank, United KingdomTaking people
- Hammersmith/Imperial HospitalLondon, United KingdomTaking people
- Royal Brompton HospitalLondon, United KingdomTaking people
- Sheffield Teaching HospitalsSheffield, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Apollo Therapeutics Ltd
- Trial code
- NCT06846554
- Record updated
- 11 May 2026
- Original description
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.Read full original descriptionShow less
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).
Inclusion: 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: 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; Diagnosed with a malignancy within 5 years of enrolment; eGFR ≤30 ml/min/1.73m2; Life expectancy of < 12 months, as assessed by the Investigator; Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods.