Testing APL-9796 for adults with pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.