A Trial of "APL-9796'' in Adults With Pulmonary Hypertension

Last updated: April 10, 2025
Sponsor: Apollo Therapeutics Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Pulmonary Arterial Hypertension

Stress

Vascular Diseases

Treatment

APL-9796

Clinical Study ID

NCT06846554
AP13CP02
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be 18 to 80 years of age inclusive

  2. Participants who are diagnosed with pulmonary hypertension via right heartcatheterisation (RHC), documented at any time prior to Screening.

  3. WHO Functional Class II or III

  4. Participant has the CardioMEMS PA Sensor implanted.

Exclusion

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 isassessed 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 samplingmethods

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: APL-9796
Phase: 2
Study Start date:
April 09, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Hammersmith/Imperial Hospital

    London, W12 0HS
    United Kingdom

    Active - Recruiting

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