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RECRUITING
NCT06846554
PHASE2

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

Sponsor: Apollo Therapeutics Ltd

View on ClinicalTrials.gov

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).

Official title: A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-04-09

Completion Date

2027-09-30

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

APL-9796

3 Cohorts are planned in Part A.

DRUG

APL-9796

The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).

Locations (5)

Hammersmith/Imperial Hospital

London, London, United Kingdom

Royal United Hospital Bath

Bath, United Kingdom

Golden Jubilee Hospital

Clydebank, United Kingdom

Royal Brompton Hospital

London, United Kingdom

Sheffield Teaching Hospitals

Sheffield, United Kingdom