Open-label Extension Study of Seralutinib in Adult Subjects with PAH
Research type
Research Study
Full title
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
IRAS ID
1009669
Contact name
Conor O'Donovan
Contact email
Sponsor organisation
GB002, Inc.
Clinicaltrials.gov Identifier
Research summary
This is an open-label, single-arm study to evaluate the long-term safety, tolerability, and efficacy of orally inhaled seralutinib in subjects 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 examine the effects of seralutinib in patients who have already completed a “blinded” clinical trial (in which the effects of seralutinib are compared to a placebo). 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 a treatment period with regular visits to the clinic (10 visits in the first year and every 16 weeks after that), and a follow-up visit 4 weeks after end of treatment.
The study treatment is a powder that is inhaled with a dry powder inhaler device, taken twice daily. At the end of the study patients are asked to complete a User Survey to evaluate ease of use and satisfaction with the study medication. The follow-up period will begin at the end of study visit.
The total number of participants to be enrolled is expected to be approximately 300 but will depend on the number of participants completing a previous seralutinib study who are eligible and consent to participate in this OLE study
The study involves procedures including physical examinations, vital signs, ECG, Six Minute Walk Test (6MWT), and pulmonary function tests. Some patients may also receive additional CT-scans of their chest.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0325
Date of REC Opinion
20 May 2024
REC opinion
Further Information Favourable Opinion