NCT06846554RecruitingPhase 2
A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 9 Apr 2025
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Apollo Therapeutics Ltd
- NCT number
- NCT06846554
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 9 Apr 2025 to the primary completion date, 30 Aug 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- eGFR ≤30 ml/min/1.73m2
Other
- Life expectancy of \< 12 months, as assessed by the Investigator
- Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal United Hospital Bath Coordinator of this site? Confirm its status | Bath | United Kingdom | Recruiting |
| Royal Papworth Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Golden Jubilee Hospital Coordinator of this site? Confirm its status | Clydebank | United Kingdom | Recruiting |
| Royal Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Hammersmith/Imperial Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Sheffield Teaching Hospitals Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.