A Trial of "APL-9796'' in Adults With Pulmonary Hypertension

Phase 2

Recruiting

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: APL-9796

• Registration Number: NCT06846554
• Lead Sponsor: Apollo Therapeutics Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-26
• Status Verified: 2025-04
• Study Start: 2025-04-09
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-08-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A: in adults with WHO Group 1 PAH.	APL-9796	Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.
Part B (optional): in adults with WHO Group 3 PH-ILD	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the Telemetry Parameters	from baseline (CFB) to Day 169	Telemetry parameter is assessed using Pulmonary arterial pressures: systolic, diastolic and mean (mPAP)
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
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 emPHasis-10 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 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)

Trial Locations

Locations (1)

Hammersmith/Imperial Hospital; 🇬🇧 London, United Kingdom