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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Hammersmith/Imperial Hospital
RECRUITING
London
Contact Information
Primary
Sanjay Aggarwal, MD
AP13@apollotx.com
781-479-2267
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 48
Treatments
Experimental: Part A: in adults with WHO Group 1 PAH.
Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.
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.
Related Therapeutic Areas
Sponsors
Leads: Apollo Therapeutics Ltd

This content was sourced from clinicaltrials.gov