A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorApollo Therapeutics Ltd
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
APL-9796
Drug3 Cohorts are planned in Part A.
APL-9796
DrugThe decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Part A: in adults with WHO Group 1 PAH.Experimental treatment 1 intervention
Group B: Part B (optional): in adults with WHO Group 3 PH-ILDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
To assess the Telemetry Parameters
Telemetry parameter is assessed using Total pulmonary resistance (TPR)
Time frame
from baseline (CFB) to Day 1692
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 1693
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 1694
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 169Sponsors and contacts
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Source ClinicalTrials.gov