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New treatment option for Pulmonary Arterial Hypertension
Official title A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
ClinicalTrials.gov ID: NCT06846554
What this study is testing
What is APL-9796?
APL-9796 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pulmonary arterial hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Participant must be 18 to 80 years of age inclusive
- Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.
- WHO Functional Class II or III
- Participant has the CardioMEMS PA Sensor implanted.
You likely can't join if
- 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 by the Investigator
- Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
- History of left-sided heart disease and/or clinically significant cardiac disease
- History of uncontrolled systemic hypertension
- eGFR ≤30 ml/min/1.73m2
See the full eligibility criteria
- Participant must be 18 to 80 years of age inclusive
- Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.
- WHO Functional Class II or III
- Participant has the CardioMEMS PA Sensor implanted.
- 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 by the Investigator
- Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
- History of left-sided heart disease and/or clinically significant cardiac disease
- History of uncontrolled systemic hypertension
- eGFR ≤30 ml/min/1.73m2
- Life expectancy of \< 12 months, as assessed by the Investigator
- Diagnosed with a malignancy within 5 years of enrolment
- Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods
The study team makes the final eligibility decision.
Where it's taking place
- London, London, United Kingdom
- Bath, United Kingdom
- Cambridge, United Kingdom
- Clydebank, United Kingdom
- London, United Kingdom
- Sheffield, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, London, United Kingdom; Bath, United Kingdom; Cambridge, United Kingdom; Clydebank, United Kingdom; London, United Kingdom; Sheffield, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.