624 Participants NeededMy employer runs this trial

GSK5784283 for COPD

Recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
Must be taking: Inhaled corticosteroids, Long-acting muscarinic antagonists, Long-acting beta-agonists
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 called GSK5784283, an experimental therapy, to determine if it can better reduce flare-ups in people with chronic obstructive pulmonary disease (COPD) compared to a placebo. Participants will continue their regular treatments and add either GSK5784283 or a placebo. The trial seeks individuals who frequently experience COPD attacks, have been diagnosed with moderate to very severe COPD, and are current or former smokers. Participants must not have asthma or other significant lung diseases. The goal is to determine if GSK5784283 can ease living with COPD by reducing severe symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for COPD.

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

Research has shown that GSK5784283 has been tested for safety and tolerability in people with COPD. In these studies, researchers administered the treatment in either repeated or single doses to assess patient management over time.

While specific side effects aren't detailed, the treatment's progression to a Phase 3 trial suggests it was well-tolerated in earlier stages. Phase 3 trials usually involve larger groups and closely monitor for serious side effects.

In earlier research phases, treatments undergo thorough safety checks. By Phase 3, major safety issues are typically identified and addressed, offering some reassurance about the treatment's safety.12345

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

Unlike the standard COPD treatments, which often include bronchodilators and corticosteroids, GSK5784283 is unique because it targets specific pathways involved in inflammation and immune response. Researchers are excited about GSK5784283 because it offers a novel mechanism of action that could provide better control of COPD symptoms and potentially reduce flare-ups more effectively than current options. This targeted approach might lead to improved lung function and quality of life for patients, making it a promising addition to the COPD treatment landscape.

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

Research has shown that GSK5784283, which participants in this trial may receive, might help reduce the frequency of flare-ups in people with moderate to severe COPD (chronic obstructive pulmonary disease). This treatment blocks a protein called TSLP, which can exacerbate lung inflammation, potentially leading to fewer episodes of worsening symptoms. In past studies, similar treatments demonstrated a clear reduction in COPD flare-ups. This suggests that GSK5784283 could be promising for people with COPD by potentially decreasing the number of serious symptom flare-ups.12467

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 to 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

Elevated COPD assessment test (CAT) score
Current or former cigarette smokers
I am using triple or dual inhaled therapy for my COPD.
See 4 more

Exclusion Criteria

I have not had cancer in the past 5 years, except for certain skin or cervical cancers.
Other significant medical conditions impacting safety or study outcomes
I have had or plan to have lung volume reduction surgery or a valve procedure.
See 7 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

Trial Overview

The study compares the new drug GSK5784283 (Felcorekibart) plus usual COPD treatment against a placebo plus usual treatment. The goal is to see if adding GSK5784283 reduces how often patients have moderate or severe COPD flare-ups.

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

GSKTrial ID 113598

A total of 596 patients were included in the study; 301 patients with asthma and 295 with COPD. Overall, the total annual direct cost per ...

Chronic Obstructive Pulmonary Disease and the ...

The study found respiratory-related deaths were more frequent in patients experiencing AECOPDs (40.3%) compared with non-exacerbators (29.2%).

A Dose Finding Study With an Anti-TSLP Antibody ...

GSK5784283 blocks the action of an inflammatory protein called TSLP that may be contributing to your asthma. chronic obstructive pulmonary ...

Evaluation of Lung Function and Symptoms in Patients ...

A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.

GSK's Nucala reduces COPD exacerbations in Phase 3 ...

The primary endpoint of the study was achieved, demonstrating a statistically significant reduction in the annual rate of moderate to severe ...

A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy ...

The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic ...

Study Details | NCT03290014 | Sleep Quality in (COPD) ...

a data safety and monitoring board, Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances. failure, asthma,