GSK3862995B for Bronchiectasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, GSK3862995B, to evaluate its effectiveness and safety for individuals with bronchiectasis, a chronic lung condition that causes coughing and mucus. Researchers aim to understand how the body processes the drug and whether it triggers any immune reactions. Participants will receive one of two doses of the medication or a placebo (a non-active treatment) to compare its effectiveness. Individuals with frequent lung infections or those who often require antibiotics might be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that GSK3862995B is likely to be safe for humans?
Earlier studies have carefully checked GSK3862995B for safety in people. Research involving individuals with bronchiectasis, a long-term lung disease, has shown that the treatment is generally well-tolerated. Although detailed results are not included here, the drug's progression to a Phase 2 trial indicates that earlier tests deemed it safe enough for further research. This phase typically means the drug has passed initial safety tests and is now being evaluated for effectiveness and potential side effects in a larger group.12345
Why do researchers think this study treatment might be promising for bronchiectasis?
Unlike the standard treatments for bronchiectasis, which typically include antibiotics and airway clearance techniques, GSK3862995B targets the underlying inflammation that leads to lung damage. This treatment is unique because it uses a novel mechanism of action that specifically interrupts inflammatory pathways, potentially reducing the frequency and severity of flare-ups. Researchers are excited about GSK3862995B because it could offer a more effective way to manage bronchiectasis by addressing the root cause rather than just alleviating symptoms.
What evidence suggests that GSK3862995B might be an effective treatment for bronchiectasis?
Research has shown that GSK3862995B helps improve symptoms in people with bronchiectasis, a long-term lung disease. This drug reduces inflammation, a major issue in this condition. Participants in this trial will receive either GSK3862995B at different dose levels or a placebo. Patients who took GSK3862995B experienced symptom relief, indicating potential effectiveness. Early results from studies on similar lung diseases also support these findings, showing promise for this new treatment.12345
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for adults with bronchiectasis confirmed by a chest scan, who have had recent lung infections needing antibiotics or hospitalization. Participants must not be pregnant or breastfeeding, should have a BMI between 18-35, and must be non-smokers or former smokers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either GSK3862995B Dose Level 1, Dose Level 2, or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSK3862995B
Trial Overview
The study tests two different doses of the new drug GSK3862995B against a placebo in adults with bronchiectasis. Participants are randomly assigned to one of these groups to compare how well the drug works and its safety.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive GSK3862995B Dose level 2.
Participants will receive GSK3862995B Dose level 1.
Participants will receive matching placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Citations
NCT07201051 | A Study to Assess the Effectiveness and ...
This study is designed to find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic lung disease.
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-assess-the-effectiveness-and-safety-of-gsk3862995b-in-adults-with-bronchiectasisA Study to Assess the Effectiveness and Safety of ...
This study is designed to find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic ...
GSK3862995B for COPD · Info for Participants
In a study involving patients with bronchiectasis, a similar lung condition, the drug improved symptoms. It targets the body's inflammation process, which ...
Respiratory Pipeline
(GSK3862995B) A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis. DISEASE (COPD) This display includes ongoing ...
GSK-3862995B - Drug Targets, Indications, Patents
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, ...
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