NCT06846554

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Apollo Therapeutics Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-04-09
• Primary completion: 2027-08-30
• Completion: 2027-09-30
• First posted: 2025-02-26
• Last updated: 2026-03-04

Locations

5 sites across 1 country: United Kingdom