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.
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.
This phase 3 study looked at the effect of Seralutinib after 24 weeks when added to background PAH disease-specific medication.
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.
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. The source data do not give full eligibility details, so the exact rules for joining cannot be listed here.
All three studies are interventional trials, which means researchers are giving a treatment and then measuring the results.
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.
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.
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.
- The current trials include both earlier and later research stages, so the program is looking at safety and possible benefit in different ways.
- 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.