Clinical trial NCT06846554: A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Official title: A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Hypertension
WHO group 3
WHO group 1 PH
Lead sponsor: Apollo Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Through study completion (approximately 2 years)
Secondary outcomes:
measure: To assess the Telemetry Parameters
timeFrame: from baseline (CFB) to Day 169
measure: To assess the Telemetry Parameters
timeFrame: from baseline (CFB) to Day 169
measure: To assess Six minute walk test / Six minute walk distance (6MWD)
timeFrame: from baseline (CFB) to Day 169
measure: To assess NT-proB-type Natriuretic Peptide (NT-proBNP)
timeFrame: from baseline (CFB) to Day 169
measure: To assess the Quality of life
timeFrame: from baseline (CFB) to Day 169
measure: To assess the Quality of life
timeFrame: from baseline (CFB) to Day 169
measure: To evaluate the PK of APL-9796 in participants with PH
timeFrame: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
measure: To evaluate the immunogenicity of APL-9796 in participants with PH.
timeFrame: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith/Imperial Hospital
Study officials:
References: