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A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Sponsor: Apollo Therapeutics Ltd
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
Conditions
Interventions
APL-9796
3 Cohorts are planned in Part A.
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