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GSK5784283

Clinical trials are studying GSK5784283 in adults with uncontrolled asthma. These studies aim to find the right dose and measure effects on airway inflammation and asthma control. The main trial listed here compares GSK5784283 with placebo in adults aged 18 to 75 years.

Table of Contents

Trial overview

The listed study of GSK5784283 is a dose finding study in adults with uncontrolled asthma.[1] It is an interventional study, which means researchers give a study treatment and compare the results with another group.[1]

The trial is authorised and plans to enroll 295 people.[1] Its main condition is asthma.[1]

Who can join the study

This trial is for adults aged 18 to 75 years with uncontrolled asthma.[1] The source data does not list any other entry rules, so this is the main participation group described for the study.[1]

What is being measured

The primary outcome is FeNO, which stands for fraction of exhaled nitric oxide, measured over 26 weeks.[1] FeNO is a breath test that can help show inflammation in the airways, the tubes that carry air in and out of the lungs.[1]

The brief summary says the study is evaluating the effect of single doses of GSK5784283 compared with placebo on FeNO.[1] A placebo is a look-alike treatment that does not contain the active study medicine.[1]

Study design and treatment groups

The interventions listed are placebo for GSK5784283 and GSK5784283 given by subcutaneous use, which means under the skin.[1] The trial record also describes this as a dose finding study, so the researchers are trying to learn which dose should be studied further.[1]

The study title and summary show that the comparison is between GSK5784283 and placebo, which helps researchers see whether the study treatment changes the outcome more than no active treatment does.[1]

What the Phase 2 label means

This study is in Phase 2.[1] Phase 2 studies usually look more closely at whether a treatment may work in the target condition and continue to collect safety information.[1]

For patients, this means the treatment is being tested in a group that has the disease, and the researchers are trying to learn more about its effect before larger studies may happen.[1]

Study Aspect Details
Drug Name GSK5784283 (also known as AIO-001, SHR-1905)
Target Condition Uncontrolled asthma in adults aged 18-75 years
Mechanism of Action Anti-TSLP antibody that blocks inflammatory protein involved in asthma
Study Design Multicentre, randomized, double-blind, placebo-controlled, Phase 2 study
Study Structure Two parts: Part A (dose finding, 26 weeks) and Part B (extended dosing, 52 weeks)
Primary Outcomes Change in fraction of exhaled nitric oxide (FeNO)
Key Secondary Outcomes Blood eosinophil counts, lung function (FEV1, FVC), asthma control (ACQ-5), safety measures
Safety Monitoring Adverse events, lab tests, vital signs, ECG, antibody development against the drug
Study ID NCT06748053

FAQ

  • What is being studied in GSK5784283 clinical trials? The trial is studying GSK5784283 in adults with uncontrolled asthma. It compares GSK5784283 with placebo to see how it affects airway inflammation.
  • Who can take part in the trial? Adults aged 18 to 75 years with uncontrolled asthma may be eligible. The trial description does not list all other entry rules.
  • What phase is the GSK5784283 trial? The listed study is a Phase 2 trial. Phase 2 studies look more closely at how well a treatment works and continue to check safety.
  • What does the trial measure? The main outcome is FeNO, which means fraction of exhaled nitric oxide. This is a marker of airway inflammation measured over 26 weeks.
  • How many people are planned for the study? The trial plans to enroll 295 people. This helps researchers compare results between the GSK5784283 group and the placebo group.

Ongoing Clinical Trials on GSK5784283

  • Study on GSK5784283 for Adults Aged 18-75 with Uncontrolled Asthma

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Romania Spain

Glossary

  • Asthma: A long-term lung condition that can cause wheezing, shortness of breath, chest tightness, and coughing.
  • Uncontrolled asthma: Asthma that is not well managed, so symptoms are still happening often or are not fully relieved.
  • Phase 2: A trial stage that looks more closely at whether a treatment may work and continues to collect safety information.
  • Interventional study: A study where researchers give a treatment or placebo and then compare the results.
  • Placebo: A treatment that looks like the study drug but does not contain the active study medicine.
  • Subcutaneous use: Given under the skin.
  • Dose finding study: A study designed to help researchers learn what dose may be appropriate to test further.
  • FeNO: Fraction of exhaled nitric oxide, a breath test that can show inflammation in the airways.
  • ppb: Parts per billion, a very small unit used to measure FeNO levels.
  • Enrollment: The number of people planned to join a study.

References