363 Participants NeededMy employer runs this trial

GSK3862995B for Bronchiectasis

Recruiting at 108 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: GlaxoSmithKline
Prior Safety DataThis treatment has passed at least one previous human trial

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?

GC

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

I am currently coughing up sputum.
Post-bronchodilator FEV1 greater than or equal to 30 percent of predicted normal value
Non-smokers or former cigarette smokers
See 8 more

Exclusion Criteria

I have been diagnosed with asthma or COPD.
My bronchiectasis is caused by a genetic or immune system condition or lung scarring.
I currently have an active non-tuberculosis mycobacterial lung infection.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either GSK3862995B Dose Level 1, Dose Level 2, or placebo

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

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

Group I: GSK3862995B Dose Level 2Experimental Treatment1 Intervention
Group II: GSK3862995B Dose Level 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
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Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

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.

A 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

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GSK-3862995B - Drug Targets, Indications, Patents

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, ...