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Seralutinib

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.

Table of contents

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.[1] 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][3]

Studies and designs

One phase 3 trial, NCT05934526, is a randomized, double-blind, placebo-controlled study in 384 participants.[2] 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.[1] 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.[3]

Who may participate

The trials are for people with PAH, and one study specifically includes subjects with WHO Group 1 pulmonary hypertension.[1][3] The source data do not give full eligibility details, so the exact rules for joining cannot be listed here.[1][2][3]

All three studies are interventional trials, which means researchers are giving a treatment and then measuring the results.[1][2][3]

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][3]

The phase 3 placebo-controlled study also measured change in distance achieved on the six-minute walk test (6MWT) from baseline to Week 24.[2] 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.[1] The phase 2 study also focuses on long-term safety and tolerability in WHO Group 1 pulmonary hypertension.[3]

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][3]

  • 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][3]

  • Some participants are already taking PAH medicines, because one phase 3 trial studied Seralutinib added to background disease-specific treatment.[2]

  • The main outcomes are safety measures and exercise-related results, which are important for understanding daily function in PAH.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollment
NCT06274801Phase 3Pulmonary Arterial HypertensionAuthorised343
NCT05934526Phase 3Pulmonary Arterial HypertensionCompleted384
NCT04816604Phase 2Pulmonary Arterial Hypertension (PAH)Authorised91

FAQ

  • What condition is being studied in Seralutinib trials? The trials are studying pulmonary arterial hypertension (PAH), including WHO Group 1 pulmonary hypertension. This is a form of high blood pressure in the lung arteries.
  • What are the main goals of these trials? The main goals are to check safety, tolerability, and how well Seralutinib works. One study also looks at exercise capacity using the six-minute walk test.
  • What phases are the Seralutinib trials in? The listed studies are in phase 2 and phase 3. Phase 2 and phase 3 trials help researchers learn more about safety and how well a treatment works.
  • Who can take part in these studies? These trials are for people with pulmonary arterial hypertension. One study includes subjects with WHO Group 1 pulmonary hypertension.
  • What outcomes are being measured? The trials measure treatment-emergent adverse events, which means health problems that start after treatment begins. One phase 3 trial also measures the change in distance walked in six minutes.

Ongoing Clinical Trials on Seralutinib

  • Study on Inhaled Seralutinib (GB002) for Patients with Pulmonary Arterial Hypertension (PAH)

    Not recruiting

    1 1
    Investigated drugs:
    Czechia Germany Spain

  • Study on Long-term Safety of Seralutinib for Patients with Pulmonary Arterial Hypertension

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +10

  • Study on Seralutinib for Treating Pulmonary Arterial Hypertension in Patients

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +10

Glossary

  • Pulmonary arterial hypertension (PAH): A type of high blood pressure that affects the arteries in the lungs. It can make it harder for the heart and lungs to work well.
  • WHO Group 1 pulmonary hypertension: A classification used for one major type of pulmonary hypertension. It helps doctors and researchers group patients with similar disease patterns.
  • Phase 2: A mid-stage clinical trial. It usually looks more closely at safety and early signs of benefit.
  • Phase 3: A later-stage clinical trial. It compares a treatment with placebo or standard care in a larger group of people.
  • Randomized: Participants are placed into treatment groups by chance. This helps make the study fair.
  • Double-blind: Neither the participants nor the study team know who is getting the study treatment or placebo during the trial. This helps reduce bias.
  • Placebo: A treatment that looks like the study drug but does not contain the active drug. It is used to compare results fairly.
  • Interventional study: A study where researchers give a treatment or procedure and then measure the results.
  • Treatment-emergent adverse events (TEAEs): Health problems that begin or get worse after treatment starts. These are tracked to understand safety.
  • Six-minute walk test (6MWT): A simple test that measures how far a person can walk in six minutes. It helps show exercise ability.
  • Tolerability: How well people can handle a treatment without too many side effects or problems.
  • Background PAH disease-specific medication: Other medicines a person is already taking for PAH while joining the study.

References