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Looking for participantsPhase2

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

Sponsor: Apollo Therapeutics Ltd

NCT ID: NCT06846554

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
APL-9796 (drug), APL-9796 (drug)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
APL-9796 — drug: 3 Cohorts are planned in Part A. · APL-9796 — drug: The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 80 Years
Who
All
Number of participants
48
Started
2025-04-09
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary arterial hypertension
  • • Phase2 - 48 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with pulmonary arterial hypertension

Where?

  • • London - Hammersmith/Imperial Hospital
  • • Bath - Royal United Hospital Bath
  • • Cambridge - Royal Papworth Hospital
  • • Clydebank - Golden Jubilee Hospital
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Pulmonary Arterial Hypertension

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 80 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Participant must be 18 to 80 years of age inclusive
  • ✓Participants who are diagnosed with lung hypertension via right heart catheterisation (RHC), documented at any...
  • ✓WHO Functional Class II or III
  • ✓Participant has the CardioMEMS PA Sensor implanted.

Who cannot take part

  • ✗Hospital admission related to PH within 3 months prior to Screening.
  • ✗Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered...
  • ✗Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital...
  • ✗History of left-sided heart disease and/or clinically significant heart disease
  • ✗History of uncontrolled systemic hypertension
See the full 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 Is This Study? (6 UK sites)

Hammersmith/Imperial Hospital

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)

Royal United Hospital Bath

Bath, United Kingdom

Recruiting
Hospital R&D contact (matched)

Amy Lloyd

ruh-tr.researchgovernance@nhs.net01225 821669

Royal Papworth Hospital

Cambridge, United Kingdom

Recruiting
Hospital R&D contact (matched)

Vikki Hughes

papworth.randdenquiries@nhs.net01223 638000

Golden Jubilee Hospital

Clydebank, United Kingdom

Recruiting

Royal Brompton Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Sanjay Aggarwal, MD

Sponsor contact

CONTACT

781-479-2267 AP13@apollotx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05