NCT06846554

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
17mo left

Started Apr 2025

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Apr 2025Sep 2027

First Submitted

Initial submission to the registry

January 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 9, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

January 10, 2025

Last Update Submit

March 3, 2026

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary HypertensionWHO group 3WHO group 1 PH

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion (approximately 2 years)

Secondary Outcomes (8)

  • To assess the Telemetry Parameters

    from baseline (CFB) to Day 169

  • To assess the Telemetry Parameters

    from baseline (CFB) to Day 169

  • To assess Six minute walk test / Six minute walk distance (6MWD)

    from baseline (CFB) to Day 169

  • To assess NT-proB-type Natriuretic Peptide (NT-proBNP)

    from baseline (CFB) to Day 169

  • To assess the Quality of life

    from baseline (CFB) to Day 169

  • +3 more secondary outcomes

Study Arms (2)

Part A: in adults with WHO Group 1 PAH.

EXPERIMENTAL

Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.

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.

Drug: APL-9796

Interventions

APL-9796DRUG

3 Cohorts are planned in Part A.

Part A: in adults with WHO Group 1 PAH.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hammersmith/Imperial Hospital

London, London, W12 0HS, United Kingdom

RECRUITING

Royal United Hospital Bath

Bath, United Kingdom

RECRUITING

Golden Jubilee Hospital

Clydebank, United Kingdom

RECRUITING

Royal Brompton Hospital

London, United Kingdom

RECRUITING

Sheffield Teaching Hospitals

Sheffield, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Sanjay Aggarwal, MD

CONTACT

781-479-2267AP13@apollotx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

February 26, 2025

Study Start

April 9, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

GB(5)