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Seralutinib

Clinical trials are studying Seralutinib in people with pulmonary arterial hypertension (PAH). The trials look at long-term safety, tolerability, and how well the treatment works, including exercise capacity. They include adults with PAH in phase 2 and phase 3 studies.

Table of contents

Overview of the Seralutinib trials

The available trial data show that Seralutinib is being studied in people with pulmonary arterial hypertension, also called PAH.[1][2][3] The studies focus on long-term safety, tolerability, and treatment effect, especially on exercise capacity.[1][2]

Which condition is being studied

All three trials in the data study pulmonary arterial hypertension.[1][2][3] One trial describes the population as WHO Group 1 PH, which is a specific group within pulmonary hypertension classification.[3]

How the trials are designed

Two studies are phase 3 trials, and one study is a phase 2 trial.[1][2][3] The phase 3 study with ID NCT05934526 is randomized, double-blind, and placebo-controlled, which means people were assigned by chance to treatment groups, neither the participants nor the study team knew the assignments, and the study compared Seralutinib with placebo.[2]

The extension study NCT06274801 is an open-label extension study, which means everyone in the study knows which treatment is being given.[1] Its purpose is to evaluate long-term safety and efficacy in people with PAH.[1]

The phase 2 study NCT04816604 is an interventional study and also looks at long-term safety and tolerability in WHO Group 1 PH.[3]

What the trials measure

The main outcome in the extension study NCT06274801 is the incidence of treatment-emergent adverse events, which means health problems that begin after treatment starts.[1] This helps researchers watch for safety issues over time.[1]

The main outcome in the phase 3 placebo-controlled study NCT05934526 is the change in distance walked on the six-minute walk test from baseline to Week 24.[2] Baseline means the starting point before treatment begins.[2] This test is used to measure exercise capacity, or how much physical activity a person can do.[2]

The phase 2 study NCT04816604 also uses treatment-emergent adverse events as its primary outcome.[3] This shows that safety is a major focus across the studies.[1][3]

Who can take part

The trial data show that the studies include people with pulmonary arterial hypertension, and one study specifically includes subjects with WHO Group 1 PH.[1][3] One phase 3 study also evaluates Seralutinib when added to background PAH disease-specific medication, meaning participants were already receiving treatment for PAH.[2]

The available data do not list detailed age limits, sex limits, or other entry rules, so only the condition-based eligibility can be confirmed from the source material.[1][2][3]

Trial status and size

One phase 3 study, NCT05934526, is completed and enrolled 384 people.[2] The open-label extension study NCT06274801 is authorised and has an enrollment of 343 people.[1] The phase 2 study NCT04816604 is also authorised and enrolled 91 people.[3]

Key trial details

  • NCT06274801 is a phase 3 open-label extension study that looks at long-term safety and efficacy in pulmonary arterial hypertension.[1]

  • NCT05934526 is a phase 3 randomized, double-blind, placebo-controlled study that measures change in the six-minute walk test after 24 weeks.[2]

  • NCT04816604 is a phase 2 study in WHO Group 1 PH that focuses on long-term safety and tolerability.[3]

Trial ID Phase Condition studied Status Enrollment
NCT05934526 Phase 3 Pulmonary arterial hypertension Completed 384
NCT06274801 Phase 3 Pulmonary arterial hypertension Authorised 343
NCT04816604 Phase 2 Pulmonary arterial hypertension (WHO Group 1 PH) Authorised 91

FAQ

  • What is being studied in the Seralutinib trials? The trials are studying Seralutinib for pulmonary arterial hypertension (PAH). Researchers want to see if it is safe and whether it helps people with PAH, especially with exercise ability.
  • Who can take part in these trials? The trials are for people with pulmonary arterial hypertension, including WHO Group 1 PAH. Some studies also look at people already taking PAH disease-specific medicine.
  • What phases are the Seralutinib trials in? The trial data include phase 2 and phase 3 studies. Phase 2 studies usually look at early safety and signals of benefit, while phase 3 studies compare treatment effects in larger groups.
  • What outcomes are measured in the trials? The main outcomes include treatment-emergent adverse events, which are side effects that start after treatment begins, and change in the six-minute walk test. The six-minute walk test checks how far a person can walk in six minutes.
  • Are all Seralutinib studies finished? No. One phase 3 study is completed, and two studies are authorised. This means some research is still ongoing or prepared for use.

Igangværende kliniske forsøg for Seralutinib

  • Afprøvning af inhaleret GB002 til behandling af forhøjet blodtryk i lungerne (pulmonal arteriel hypertension)

    Rekrutterer ikke

    1 1
    Undersøgte lægemidler:
    Tjekkiet Tyskland Spanien

  • Langtidsstudie af inhaleret seralutinib til behandling af forhøjet blodtryk i lungerne (pulmonal arteriel hypertension)

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Østrig Belgien Tjekkiet Danmark Frankrig Tyskland +10

  • Test af seralutinib-inhalator til behandling af forhøjet blodtryk i lungerne (pulmonal arteriel hypertension)

    Rekrutterer ikke

    1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Østrig Belgien Tjekkiet Danmark Frankrig Tyskland +10

Ordliste

  • Pulmonary arterial hypertension (PAH): A disease that causes high blood pressure in the arteries of the lungs. It can make it harder for the heart and lungs to work well.
  • WHO Group 1 PH: A type of pulmonary hypertension classified by the World Health Organization. It refers to a specific group of patients with high pressure in the lung arteries.
  • Phase 2: An early clinical trial phase that looks at safety and whether the treatment shows signs of working.
  • Phase 3: A later trial phase that studies safety and effectiveness in a larger number of people.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare results.
  • Placebo: A look-alike treatment with no active medicine. It helps researchers see whether the study drug works better than no active treatment.
  • Randomized: Participants are assigned by chance to different study groups. This helps make the comparison fair.
  • Double-blind: Neither the participants nor the study team know who gets the study drug or placebo during the study. This helps reduce bias.
  • Exercise capacity: How well a person can do physical activity, such as walking. In these trials, it is measured with a walking test.
  • Six-minute walk test (6MWT): A simple test that measures how far a person can walk in six minutes. It helps show how well the lungs and heart are working.
  • Treatment-emergent adverse events (TEAEs): Health problems or side effects that begin after treatment starts, even if they may not be caused by the treatment.
  • Tolerability: How well people can handle a treatment without too much discomfort or side effects.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/langtidsstudie-af-inhaleret-seralutinib-til-behandling-af-forhojet-blodtryk-i-lungerne-pulmonal-arteriel-hypertension/
  2. https://kliniske-forsoeg.dk/forsog/test-af-seralutinib-inhalator-til-behandling-af-forhojet-blodtryk-i-lungerne-pulmonal-arteriel-hypertension/
  3. https://kliniske-forsoeg.dk/forsog/afprovning-af-inhaleret-gb002-til-behandling-af-forhojet-blodtryk-i-lungerne-pulmonal-arteriel-hypertension/