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

Apollo Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: APL-9796

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846554

AP13CP02

Details and patient eligibility

About

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).

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Part A: in adults with WHO Group 1 PAH.

Experimental group

Description:

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

Treatment:

Drug: APL-9796

Drug: APL-9796

Part B (optional): in adults with WHO Group 3 PH-ILD

Experimental group

Description:

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.

Treatment:

Drug: APL-9796

Drug: APL-9796