Pulmonary Arterial Hypertension
Conditions
Keywords
Pulmonary Hypertension, WHO group 3, WHO group 1 PH
Brief summary
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).
Interventions
DRUGAPL-9796
3 Cohorts are planned in Part A.
Sponsors
Apollo Therapeutics Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Participant must be 18 to 80 years of age inclusive 2. Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening. 3. WHO Functional Class II or III 4. Participant has the CardioMEMS PA Sensor implanted.
Exclusion criteria
1. Hospital admission related to PH within 3 months prior to Screening. 2. Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator 3. Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease 4. History of left-sided heart disease and/or clinically significant cardiac disease 5. History of uncontrolled systemic hypertension 6. eGFR ≤30 ml/min/1.73m2 7. Life expectancy of \< 12 months, as assessed by the Investigator 8. Diagnosed with a malignancy within 5 years of enrolment 9. Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through study completion (approximately 2 years) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the Telemetry Parameters | from baseline (CFB) to Day 169 | Telemetry parameter is assessed using Total pulmonary resistance (TPR) |
| To evaluate the immunogenicity of APL-9796 in participants with PH. | at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508 | * Incidence of anti-drug antibody (ADA) against APL-9796 (including titres) * Incidence of neutralising antibody (Nab) against APL-9796 (including titres) |
| To assess NT-proB-type Natriuretic Peptide (NT-proBNP) | from baseline (CFB) to Day 169 | The level of NT-proBNP is assessed by blood sample collection and analysis |
| To assess the Quality of life | from baseline (CFB) to Day 169 | Quality of life is assessed using SF-36 questionnaire |
| To evaluate the PK of APL-9796 in participants with PH | at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508 | APL-9796 concentrations in serum |
| To assess Six minute walk test / Six minute walk distance (6MWD) | from baseline (CFB) to Day 169 | A 6-minute walk test (6MWT) is assessed per the guidelines of the American Thoracic Society 2003 |
Countries
United Kingdom
Contacts
CONTACTSanjay Aggarwal, MD
Outcome results
None listed