RecruitingPhase 2NCT06846554

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)

Sponsor

Apollo Therapeutics Ltd

Enrollment

48 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called APL-9796 in adults with pulmonary hypertension (a condition where blood pressure in the lungs' arteries is dangerously high), to see if it can safely lower lung artery pressure and improve quality of life. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with pulmonary hypertension confirmed by a right heart catheterization procedure - You are in WHO Functional Class II or III (meaning your symptoms limit you during normal or even mild physical activity) - You have a CardioMEMS PA Sensor implanted (a small wireless device in your lung artery that monitors pressure) **You may NOT be eligible if...** - You were hospitalized for pulmonary hypertension within the last 3 months - You had major surgery in the last 3 months - Your pulmonary hypertension is caused by HIV, certain medications, or specific rare conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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