A Trial of "APL-9796'' in Adults With Pulmonary Hypertension (ViTAL-PH)

May 6, 2026 updated by: Apollo Therapeutics Ltd

A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Bath, United Kingdom
        • Recruiting
        • Royal United Hospital Bath
      • Cambridge, United Kingdom
        • Recruiting
        • Royal Papworth Hospital
      • Clydebank, United Kingdom
        • Recruiting
        • Golden Jubilee Hospital
      • London, United Kingdom
        • Recruiting
        • Royal Brompton Hospital
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals
    • London
      • London, London, United Kingdom, W12 0HS
        • Recruiting
        • Hammersmith/Imperial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: in adults with WHO Group 1 PAH.
Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.
Drug: APL-9796
3 Cohorts are planned in Part A.
Drug: APL-9796
The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).
Experimental: Part B (optional): in adults with WHO Group 3 PH-ILD
Cohorts will be enrolled sequentially at N=4, at a dose level determined by the Safety Review Committee (SRC) based on data from Part A.
Drug: APL-9796
3 Cohorts are planned in Part A.
Drug: APL-9796
The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Through study completion (approximately 2 years)
Number of participants who experience Treatment-Emergent Adverse Events will be reported which also include the frequency, severity (CTCAE V5.0) and relationship (causality) of AEs
Through study completion (approximately 2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the Telemetry Parameters
Time Frame: from baseline (CFB) to Day 169
Telemetry parameter is assessed using Total pulmonary resistance (TPR)
from baseline (CFB) to Day 169
To assess the Telemetry Parameters
Time Frame: from baseline (CFB) to Day 169
Telemetry parameter is assessed using Pulmonary arterial pressures: systolic, diastolic and mean (mPAP)
from baseline (CFB) to Day 169
To assess Six minute walk test / Six minute walk distance (6MWD)
Time Frame: from baseline (CFB) to Day 169
A 6-minute walk test (6MWT) is assessed per the guidelines of the American Thoracic Society 2003
from baseline (CFB) to Day 169
To assess NT-proB-type Natriuretic Peptide (NT-proBNP)
Time Frame: from baseline (CFB) to Day 169
The level of NT-proBNP is assessed by blood sample collection and analysis
from baseline (CFB) to Day 169
To assess the Quality of life
Time Frame: from baseline (CFB) to Day 169
Quality of life is assessed using SF-36 questionnaire
from baseline (CFB) to Day 169
To assess the Quality of life
Time Frame: from baseline (CFB) to Day 169
Quality of life is assessed using emPHasis-10 questionnaire
from baseline (CFB) to Day 169
To evaluate the PK of APL-9796 in participants with PH
Time Frame: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
APL-9796 concentrations in serum
at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
To evaluate the immunogenicity of APL-9796 in participants with PH.
Time Frame: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
  • Incidence of anti-drug antibody (ADA) against APL-9796 (including titres)
  • Incidence of neutralising antibody (Nab) against APL-9796 (including titres)
at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Apollo Therapeutics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AP13CP02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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