In short
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.
Key points
- GSK5784283 is being studied in a Phase 2 trial for adults with uncontrolled asthma. The listed study is a dose finding study and compares GSK5784283 with placebo. Researchers are looking at fraction of exhaled nitric oxide, or FeNO, which is a marker of airway inflammation. The trial includes adults aged 18 to 75 years. The planned enrollment is 295 participants. The study status is Authorised.
At a glance
- 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
Trial overview
The listed study of GSK5784283 is a dose finding study in adults with uncontrolled asthma. It is an interventional study, which means researchers give a study treatment and compare the results with another group.
The trial is authorised and plans to enroll 295 people. Its main condition is asthma.
Who can join the study
This trial is for adults aged 18 to 75 years with uncontrolled asthma. The source data does not list any other entry rules, so this is the main participation group described for the study.
What is being measured
The primary outcome is FeNO, which stands for fraction of exhaled nitric oxide, measured over 26 weeks. FeNO is a breath test that can help show inflammation in the airways, the tubes that carry air in and out of the lungs.
The brief summary says the study is evaluating the effect of single doses of GSK5784283 compared with placebo on FeNO. A placebo is a look-alike treatment that does not contain the active study medicine.
Study design and treatment groups
The interventions listed are placebo for GSK5784283 and GSK5784283 given by subcutaneous use, which means under the skin. The trial record also describes this as a dose finding study, so the researchers are trying to learn which dose should be studied further.
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.
What the Phase 2 label means
This study is in Phase 2. Phase 2 studies usually look more closely at whether a treatment may work in the target condition and continue to collect safety information.
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.