624 Participants NeededMy employer runs this trial

GSK5784283 for COPD

Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
Must be taking: Inhaled corticosteroids, LAMA, LABA
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 treatment, GSK5784283 (Felcorekibart), to determine if it can better prevent flare-ups in people with COPD compared to a placebo. Participants will continue their usual COPD treatments while receiving either the new drug or a placebo. This trial suits current or former smokers who frequently experience COPD flare-ups and use certain inhaler medications. The researchers aim to discover if adding GSK5784283 can reduce the number of severe breathing episodes each year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that GSK5784283 is likely to be safe for humans?

Research has shown that GSK5784283, also known as Felcorekibart, is being tested as a new treatment for COPD (chronic obstructive pulmonary disease). In earlier studies, patients generally tolerated the treatment well, with few serious side effects. Some participants experienced mild to moderate side effects, but these were usually manageable. The available information does not provide exact details of these side effects.

The current trial is in a late stage, indicating that the treatment has already passed initial safety tests in humans. This suggests that GSK5784283 is reasonably safe at this point. However, all treatments can have risks. Prospective participants should discuss possible side effects with their doctor before joining the trial.12345

Why do researchers think this study treatment might be promising for COPD?

Felcorekibart, or GSK5784283, is unique because it targets COPD in a novel way. Unlike standard treatments such as bronchodilators and corticosteroids that mainly focus on relieving symptoms, Felcorekibart acts on a specific inflammatory pathway to potentially modify the disease itself. Researchers are excited about this treatment because it could offer more than just symptom relief by addressing the underlying inflammation, which might slow down disease progression and improve long-term outcomes for patients.

What evidence suggests that GSK5784283 might be an effective treatment for COPD?

This trial will evaluate GSK5784283, also known as Felcorekibart, for its potential to help people with chronic obstructive pulmonary disease (COPD) by reducing flare-ups. Participants will receive either GSK5784283 plus standard care or a matching placebo plus standard care. Studies have shown that people with asthma, a condition somewhat related to COPD, responded well to this treatment, suggesting it might also work for COPD. The treatment targets specific parts of the immune system involved in inflammation, a major issue in COPD. While more research is needed to confirm its effectiveness for COPD specifically, these early results are promising.678910

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 men and women aged 40–80 who have moderate to very severe COPD with frequent flare-ups, higher symptom scores, and a specific blood marker (eosinophilic type). Participants must be current or former smokers already using inhaled COPD medications.

Inclusion Criteria

* Participants with elevated COPD assessment test (CAT) score.
* Current or former cigarette smokers.
I am between 40 and 80 years old.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK5784283 or placebo as an add-on therapy to standard of care

78 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GSK5784283 (Felcorekibart)

Trial Overview

The study compares the new drug GSK5784283 (Felcorekibart) plus standard care against a placebo plus standard care. The goal is to see if adding GSK5784283 reduces serious COPD flare-ups more than placebo. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving GSK5784283 plus standard of careExperimental Treatment2 Interventions
Group II: Participants receiving matching placebo plus standard of carePlacebo Group2 Interventions

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
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
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

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