In short
Clinical trials are studying seralutinib in people with pulmonary arterial hypertension, a serious type of high blood pressure in the lungs. These studies look at long-term safety, tolerability, and whether seralutinib can improve exercise ability and other outcomes. The trials include adults with PAH in phase 2 and phase 3 research.
Key points
- Clinical trials of seralutinib are studying pulmonary arterial hypertension, including WHO Group 1 pulmonary hypertension. The research includes one phase 2 study and two phase 3 studies. The main goals are to assess long-term safety, tolerability, and whether the treatment can improve exercise capacity. One phase 3 trial compares seralutinib with placebo, and another looks at long-term safety in people with PAH. The studies include adults with PAH and use measures such as treatment-emergent adverse events and the six-minute walk test.
Clinical trials overview
Seralutinib is being studied in pulmonary arterial hypertension (PAH), which is a form of high blood pressure in the arteries of the lungs. The trial data show research in both phase 2 and phase 3 settings, with the goal of learning more about safety, tolerability, and benefit in people with PAH.[1][2]
Studies and designs
One phase 3 trial, NCT05934526, is a randomized, double-blind, placebo-controlled study in 384 participants. Randomized means people are assigned by chance, double-blind means neither the participants nor the study team know who gets which treatment, and placebo-controlled means the study compares seralutinib with a look-alike treatment that does not contain the active drug.[2]
This phase 3 study looked at the effect of seralutinib after 24 weeks when added to background PAH disease-specific medication.[2]
Another phase 3 study, NCT06274801, is an open-label extension study in 343 people. Open-label means both the participants and the study team know what treatment is being given.[1]
The phase 2 study, NCT04816604, includes 91 participants with WHO Group 1 pulmonary hypertension and focuses on long-term safety and tolerability.
Who may participate
The trials are for people with PAH, and one study specifically includes subjects with WHO Group 1 pulmonary hypertension.[1] The source data do not give full eligibility details, so the exact rules for joining cannot be listed here.[1][2]
All three studies are interventional trials, which means researchers are giving a treatment and then measuring the results.[1][2]
What is measured in the trials
The main safety measure in the listed studies is the incidence of treatment-emergent adverse events (TEAEs), which means health problems that start after treatment begins.[1]
The phase 3 placebo-controlled study also measured change in distance achieved on the six-minute walk test (6MWT) from baseline to Week 24. This test shows how far a person can walk in six minutes and gives a simple picture of exercise ability.[2]
The phase 3 extension study is designed to evaluate long-term safety and efficacy, meaning whether the treatment remains safe over time and whether it continues to help. The phase 2 study also focuses on long-term safety and tolerability in WHO Group 1 pulmonary hypertension.
Key patient points
- Seralutinib is being studied as a treatment for PAH, not as a general medicine for all types of high blood pressure.[1][2]
- The current trials include both earlier and later research stages, so the program is looking at safety and possible benefit in different ways.[1][2]
- Some participants are already taking PAH medicines, because one phase 3 trial studied seralutinib added to background disease-specific treatment.
- The main outcomes are safety measures and exercise-related results, which are important for understanding daily function in PAH.[1][2]