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Can a new drug curb COPD Flare-Ups?

NCT ID NCT07780669

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether an investigational drug called felcorekibart, when added to standard COPD therapy, can reduce the number of moderate and severe flare-ups in adults aged 40 to 80 with moderate to very severe COPD. Participants will receive either felcorekibart or a placebo, and researchers will track how often exacerbations occur over the study period. The trial also measures changes in respiratory symptoms and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
felcorekibart (GSK5784283), an investigational add-on therapy
What this could lead to
If successful, this could provide a new add-on treatment to reduce the frequency of COPD flare-ups, potentially improving quality of life for people with this chronic lung disease.
What could go wrong
The trial is in phase 3, but results are not yet known. The drug may not prove more effective than placebo, and there could be side effects. Success in this trial does not guarantee regulatory approval or benefit for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 624 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or eligible female participants * Participants with \>=40 to less than or equal to (\<=) 80 years of age. * An eosinophilic phenotype with elevated BEC. * Moderate to very severe COPD with frequent exacerbations. * Participants with elevated COPD assessment test (CAT) score. * Current or former cigarette smokers. * On triple (Inhaled corticosteroid \[ICS\]+ Long-acting muscarinic antagonist \[LAMA\]+ Long-acting beta-agonist \[LABA\]) or dual inhaled COPD therapy, if ICS is considered not appropriate. Exclusion Criteria: * Current or prior physician diagnosis of asthma * Other clinically significant lung disease. * Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1. * Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure. * Continuous oxygen therapy (more than 16 hours/ day). * Cor pulmonale resulting in right heart failure and severe pulmonary hypertension. * A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix). * Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia. * New York Heart Association class III or IV heart failure. * Other significant medical conditions that could impact participants' safety or study outcomes.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary disease, chronic obstructive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Doral, Florida, 33172, United States

  • GSK Investigational Site

    RECRUITING

    Lake Charles, Louisiana, 70605, United States

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