In short
Clinical trials are investigating GSK3862995B in people with bronchiectasis. These studies look at how well it works, how safe it is, and how the body handles repeat doses. The main trial is in adults 18 to 85 years old with recurrent exacerbations or uncontrolled symptoms.
Key points
- Clinical trials of GSK3862995B are studying bronchiectasis in adults aged 18 to 85 years. The main trial is a Phase 2 interventional study with 363 participants. Researchers are comparing GSK3862995B with placebo to see whether it lowers the annualized exacerbation rate and to assess safety, immunogenicity, and pharmacokinetics. The study focuses on adults with recurrent exacerbations or uncontrolled symptoms. The trial is authorised and uses subcutaneous dosing in the study design.
Trial overview
The available clinical trial of GSK3862995B is an interventional study in bronchiectasis. It is designed to compare GSK3862995B with placebo and to assess efficacy, safety, immunogenicity, and pharmacokinetics.
The study is authorised and listed as Phase 2.
Who is being studied
This study includes participants with bronchiectasis who are 18 to 85 years old, inclusive.
The trial focuses on adults with recurrent exacerbations or uncontrolled symptoms, which means people who keep having flare-ups or do not have their symptoms well controlled.
What the study measures
The main outcome is the percentage reduction in the annualized exacerbation rate on GSK3862995B versus placebo.
This outcome is assessed in adult patients with bronchiectasis and recurrent exacerbations or uncontrolled symptoms, assuming no study treatment discontinuation, no change in maintenance standard of care, and no use of prohibited medications.
In simple terms, the researchers want to know whether people taking GSK3862995B have fewer flare-ups over a year than people taking placebo.
Trial design and treatment comparison
The study compares GSK3862995B with placebo, and the intervention is given subcutaneously, meaning under the skin.
The trial also includes 5% Dextrose Injection as part of the listed interventions.
Because this is an interventional study, researchers actively give the study treatment and then measure the results over time.
Trial phase and size
This is a Phase 2 trial, which usually means the study is looking more closely at whether a treatment may help and continuing to monitor safety.
The planned enrollment is 363 participants.
The trial status is authorised.
Patient-friendly terms
- Bronchiectasis is a long-term lung disease where the airways stay widened and can collect mucus, which may lead to repeated infections and symptoms.
- Exacerbation means a flare-up or worsening of symptoms.
- Placebo is a look-alike treatment without the active study drug, used for comparison.
- Pharmacokinetics means how the body handles a treatment after it is given.
- Immunogenicity means whether the body makes an immune response against the treatment.