Pulmonary Arterial HypertensionPhase 2ViTAL-PHNCT06846554
A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
A Phase 2 study testing APL-9796 in people with Pulmonary Arterial Hypertension, run by Apollo Therapeutics Ltd at 6 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- APL-9796
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 9 Apr 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
Royal United Hospital Bath
Bath
- Recruiting
Royal Papworth Hospital
Cambridge
- Recruiting
Golden Jubilee Hospital
Clydebank
- Recruiting
Hammersmith/Imperial Hospital
London, London, W12 0HS
Luke Howard, Professor, +44 20 3313 3171, l.howard@imperial.nhs.uk
- Recruiting
Royal Brompton Hospital
London
- Recruiting
Sheffield Teaching Hospitals
Sheffield
About this study
Official title: 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).
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- APL-9796
- Keywords
- Pulmonary Hypertension, WHO group 3, WHO group 1 PH
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL-9796Drug
3 Cohorts are planned in Part A.
APL-9796Drug
The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).
| Study group | Role | What they receive |
|---|---|---|
| Part A: in adults with WHO Group 1 PAH. | Experimental | Three (3) APL-9796 dose levels are planned for evaluation using BOIN design. Receives: Drug: APL-9796 |
| Part B (optional): in adults with WHO Group 3 PH-ILD | Experimental | 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. Receives: Drug: APL-9796 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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
Measured: Through study completion (approximately 2 years)
Secondary outcomes (8)
To assess the Telemetry Parameters
Telemetry parameter is assessed using Total pulmonary resistance (TPR)
Measured: from baseline (CFB) to Day 169
To assess the Telemetry Parameters
Telemetry parameter is assessed using Pulmonary arterial pressures: systolic, diastolic and mean (mPAP)
Measured: from baseline (CFB) to Day 169
To assess Six minute walk test / Six minute walk distance (6MWD)
A 6-minute walk test (6MWT) is assessed per the guidelines of the American Thoracic Society 2003
Measured: from baseline (CFB) to Day 169
To assess NT-proB-type Natriuretic Peptide (NT-proBNP)
The level of NT-proBNP is assessed by blood sample collection and analysis
Measured: from baseline (CFB) to Day 169
To assess the Quality of life
Quality of life is assessed using SF-36 questionnaire
Measured: from baseline (CFB) to Day 169
To assess the Quality of life
Quality of life is assessed using emPHasis-10 questionnaire
Measured: from baseline (CFB) to Day 169
To evaluate the PK of APL-9796 in participants with PH
APL-9796 concentrations in serum
Measured: 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.
- Incidence of anti-drug antibody (ADA) against APL-9796 (including titres)
- Incidence of neutralising antibody (Nab) against APL-9796 (including titres)
Measured: at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start9 Apr 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apollo Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846554
- Sponsor's protocol ID
- AP13CP02
- Acronym
- ViTAL-PH
- Status last verified
- May 2026
- First submitted
- 10 Jan 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)
- ClinicalTrials.gov ID
- NCT06846554
- Acronym / sponsor ID
- ViTAL-PH / AP13CP02
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Hypertension, WHO group 3, WHO group 1 PH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Apollo Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: in adults with WHO Group 1 PAH. | Experimental | Drug: APL-9796Three (3) APL-9796 dose levels are planned for evaluation using BOIN design. |
| Part B (optional): in adults with WHO Group 3 PH-ILD | Experimental | Drug: APL-9796Cohorts will be enrolled sequentially at N=4, at a dose level determined by the Safety Review Committee (SRC) based on data from Part A. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APL-97963 Cohorts are planned in Part A. | Drug | Part A: in adults with WHO Group 1 PAH. |
| APL-9796The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC). | Drug | Part B (optional): in adults with WHO Group 3 PH-ILD |
Primary outcome
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
8 secondary outcomes
To assess the Telemetry Parameters
Time frame: from baseline (CFB) to Day 169
To assess the Telemetry Parameters
Time frame: 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
To assess NT-proB-type Natriuretic Peptide (NT-proBNP)
Time frame: from baseline (CFB) to Day 169
To assess the Quality of life
Time frame: from baseline (CFB) to Day 169
To assess the Quality of life
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APL-9796 in people with Pulmonary Arterial Hypertension, run by Apollo Therapeutics Ltd at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Aggarwal, MD (781-479-2267, AP13@apollotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Through study completion (approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.