Testing APL-9796 for adults with pulmonary hypertension
A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)
This study is testing a new treatment called APL-9796 to see if it is safe and helps adults with pulmonary hypertension feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Apollo Therapeutics Ltd Industry-sponsored |
| Locations | 6 sites (London, London and 5 other locations) |
| Trial ID | NCT06846554 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial evaluates the safety and tolerability of multiple subcutaneous injections of APL-9796 in adults diagnosed with pulmonary hypertension. The study is divided into two parts, with Part A focusing on patients with WHO Group 1 pulmonary arterial hypertension and Part B optionally including those with WHO Group 3 pulmonary hypertension associated with interstitial lung disease. The trial will also assess the effectiveness of APL-9796 and the body's immune response to the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a confirmed diagnosis of pulmonary hypertension and a CardioMEMS PA Sensor implanted.
Not a fit: Patients with pulmonary hypertension due to specific causes like HIV or portal hypertension, or those with significant cardiac disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from pulmonary hypertension.
How similar studies have performed: Other studies have shown promise in treating pulmonary hypertension with novel therapies, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London, London and 5 other locations
- Hammersmith/Imperial Hospital — London, London, United Kingdom (Recruiting)
- Royal United Hospital Bath — Bath, United Kingdom (Recruiting)
- Royal Papworth Hospital — Cambridge, United Kingdom (Recruiting)
- Golden Jubilee Hospital — Clydebank, United Kingdom (Recruiting)
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
- Sheffield Teaching Hospitals — Sheffield, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sanjay Aggarwal, MD
- Email: AP13@apollotx.com
- Phone: 781-479-2267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.