A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Recruiting now · Phase 2
Conditions studied: Pulmonary Arterial Hypertension
In brief
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).
Key facts
- Study ID
- NCT06846554
- Run by
- Apollo Therapeutics Ltd
- People needed
- 48
- Starts
- 2025-04-09
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Hammersmith/Imperial Hospital — London, London, United Kingdom (enrolling)
- Royal United Hospital Bath — Bath, United Kingdom (enrolling)
- Royal Papworth Hospital — Cambridge, United Kingdom (enrolling)
- Golden Jubilee Hospital — Clydebank, United Kingdom (enrolling)
- Royal Brompton Hospital — London, United Kingdom (enrolling)
- Sheffield Teaching Hospitals — Sheffield, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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