Efficacy & Safety of Seralutinib in Adult Participants with PAH
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
This is a randomised, double-blind study to evaluate the efficacy and safety of seralutinib in patients with Pulmonary Arterial Hypertension (PAH). PAH is a progressive, ultimately fatal disease that affects the daily activity and quality of life of patients. The purpose of this study is to compare the effects of seralutinib to placebo (an inactive substance that looks like seralutinib, given the same way but has no effect on the body) on the ability to exercise when it is given to PAH patients who are already taking other PAH medications. This Phase 3 study is supported by data from the Phase 2 TORREY study, in which participants taking existing therapy for PAH were randomised to receive seralutinib or placebo for 24 weeks. The TORREY study demonstrated a statistically significant improvement in its primary endpoint, pulmonary vascular resistance (PVR).
Seralutinib was formulated to be inhaled so that it is delivered right where it is needed. This also means the amount of medication in the body is reduced.
This study includes screening, a treatment period, and follow-up with 14 required visits over 52 weeks. The study treatment is a powder that is inhaled with a dry powder inhaler device, taken twice daily. During the study patients are asked to complete questionnaires relating to quality of life, their PAH symptoms and their experience taking the study medication. The follow-up period will begin at the end of study visit. Approximately 350 participants will be randomly assigned in a 1:1 ratio to either seralutinib or placebo.
The study involves procedures including physical examinations, vital signs, ECG, Six Minute Walk Test (6MWT) , pulmonary function test and during screening, if required, a chest CT-scan or a lung ventilation/perfusion scan maybe performed, as well as an echocardiogram. Some patients may also receive additional CT.
South Central - Berkshire Research Ethics Committee
Date of REC Opinion
30 Oct 2023
Further Information Favourable Opinion