A Phase 2 interventional study of APL-9796 and APL-9796 in Pulmonary Arterial Hypertension, sponsored by Apollo Therapeutics Ltd. Recruiting at 6 sites in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Apollo Therapeutics Ltd · Phase 2, Interventional, and Treatment
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:
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's planned enrollment of 48 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Apollo Therapeutics Ltd is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.
Drug: APL-9796
Cohorts will be enrolled sequentially at N=4, at a dose level determined by the Safety Review Committee (SRC) based on data from Part A.
Drug: APL-9796
3 Cohorts are planned in Part A.
The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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
Time frame: Through study completion (approximately 2 years)
To assess the Telemetry Parameters
Telemetry parameter is assessed using Total pulmonary resistance (TPR)
Time frame: from baseline (CFB) to Day 169
To assess the Telemetry Parameters
Telemetry parameter is assessed using Pulmonary arterial pressures: systolic, diastolic and mean (mPAP)
Time frame: from baseline (CFB) to Day 169
To assess Six minute walk test / Six minute walk distance (6MWD)
A 6-minute walk test (6MWT) is assessed per the guidelines of the American Thoracic Society 2003
Time frame: from baseline (CFB) to Day 169
To assess NT-proB-type Natriuretic Peptide (NT-proBNP)
The level of NT-proBNP is assessed by blood sample collection and analysis
Time frame: from baseline (CFB) to Day 169
To assess the Quality of life
Quality of life is assessed using SF-36 questionnaire
Time frame: from baseline (CFB) to Day 169
To assess the Quality of life
Quality of life is assessed using emPHasis-10 questionnaire
Time frame: from baseline (CFB) to Day 169
To evaluate the PK of APL-9796 in participants with PH
APL-9796 concentrations in serum
Time frame: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
To evaluate the immunogenicity of APL-9796 in participants with PH.
* Incidence of anti-drug antibody (ADA) against APL-9796 (including titres) * Incidence of neutralising antibody (Nab) against APL-9796 (including titres)
Time frame: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Pulmonary Arterial Hypertension→
Apollo Therapeutics Ltd