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New drug aims to cut COPD Flare-Ups in patients with type 2 inflammation

NCT ID NCT06961214

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called depemokimab in adults aged 40 to 80 with moderate to severe COPD and type 2 inflammation. The goal is to see if adding this medicine to standard care can reduce the number of serious flare-ups that require steroids, antibiotics, or hospital stays. About 960 participants will receive either depemokimab or a placebo, and researchers will track how often flare-ups occur over time.

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 960 people

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

Started

Jun 2025

Expected to finish

Aug 2029

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: * Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the Informed consent * Elevated Blood Eosinophil Count (BEC) * Moderate to severe COPD with frequent exacerbations, defined as: * A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year * A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values * A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening * COPD assessment test (CAT) score \>=10 at Visit 1 * Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years. * Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1 * Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2) * Male and eligible female participants Exclusion Criteria: The following subjects are excluded: * Participants with a current or prior physician diagnosis of asthma * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease * Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1 * Lung resection: Participants with a history of or plan for lung volume reduction surgery / endobronchial valve procedure. * Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1 * Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day * Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension * Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]) * Unstable cardiovascular disease or arrhythmia * Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

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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

    159 sites in 15 countries. 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

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    Sheffield, Alabama, 35660, United States

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    Aurora, Colorado, 80012, United States

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    Brooksville, Florida, 346135, United States

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    Doral, Florida, 33172, United States

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    Fort Lauderdale, Florida, 33316, United States

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    Miami, Florida, 33122, United States

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    Miami, Florida, 33125, United States

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    Miami, Florida, 33155, United States

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    Miami, Florida, 33165, United States

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    Miami, Florida, 33175, United States

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    Miami, Florida, 33176, United States

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    Miami, Florida, 33176, United States

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    Miami Lakes, Florida, 33016, United States

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    Naples, Florida, 34102, United States

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    New Port Richey, Florida, 34653, United States

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    Ocala, Florida, 34471, United States

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    Orlando, Florida, 32825, United States

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    Ormond Beach, Florida, 32174, United States

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    Palmetto Bay, Florida, 33157, United States

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    St. Petersburg, Florida, 33704, United States

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    Adairsville, Georgia, 30103, United States

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    Cordele, Georgia, 31015, United States

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    East Point, Georgia, 30344, United States

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    Morrow, Georgia, 30260, United States

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    Boise, Idaho, 83702, United States

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    Chicago, Illinois, 60608, United States

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    Baton Rouge, Louisiana, 70816, United States

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    Lafayette, Louisiana, 70506, United States

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    Shreveport, Louisiana, 71105, United States

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    Bangor, Maine, 04401, United States

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    Rockville, Maryland, 20854, United States

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    Allen Park, Michigan, 48101, United States

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    Detroit, Michigan, 48202, United States

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    Garden City, Michigan, 48135, United States

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    Troy, Michigan, 48085, United States

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    Las Vegas, Nevada, 89144, United States

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    Moorestown, New Jersey, 08057, United States

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    Sewell, New Jersey, 08080, United States

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    Mount Kisco, New York, 10549, United States

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    New Windsor, New York, 12553, United States

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    Shelby, North Carolina, 28152, United States

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    DuBois, Pennsylvania, 15801, United States

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    Philadelphia, Pennsylvania, 19140, United States

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    Spartanburg, South Carolina, 29303, United States

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    Union, South Carolina, 29379, United States

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    Knoxville, Tennessee, 37919, United States

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    Austin, Texas, 78744, United States

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    Dallas, Texas, 75254, United States

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    El Paso, Texas, 79902-1123, United States

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    Houston, Texas, 77094, United States

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    Lampasas, Texas, 76550, United States

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    Richmond, Texas, 77407, United States

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    San Antonio, Texas, 78229, United States

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    Webster, Texas, 77598, United States

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    Morgantown, West Virginia, 26505-0423, United States

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    Buenos Aires, C1425BAD, Argentina

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    Buenos Aires, C1426ABP, Argentina

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    Córdoba, X5800AEV, Argentina

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    Quilmes, 1878, Argentina

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    Santa Fe, S3000ASF, Argentina

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    Coffs Harbour, New South Wales, 2450, Australia

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    Maroubra, New South Wales, 2035, Australia

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    Westmead, New South Wales, 2145, Australia

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    Midland, Western Australia, 6056, Australia

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    Graz, 8036, Austria

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    Innsbruck, 6020, Austria

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    Klagenfurt, 9020, Austria

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    Linz, 4020, Austria

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    Linz, 4020, Austria

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    Linz, 4021, Austria

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    Vienna, A-1090, Austria

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    Dupnitsa, 2600, Bulgaria

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    Haskovo, 6300, Bulgaria

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    Lovech, 5500, Bulgaria

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    Montana, 3400, Bulgaria

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    Montana, 3400, Bulgaria

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    Pleven, 5800, Bulgaria

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    Rousse, 7002, Bulgaria

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    Rousse, 7002, Bulgaria

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    Sofia, 1510, Bulgaria

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    Sofia, 1680, Bulgaria

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    Jindřichův Hradec, 377 01, Czechia

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    Kralupy nad Vltavou, 278 01, Czechia

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    Nymburk, 288 02, Czechia

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    Prague, 12000, Czechia

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    Varnsdorf, 407 47, Czechia

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    Munich, Bavaria, 80335, Germany

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    Offenbach, Hesse, 63065, Germany

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    Rheine, North Rhine-Westphalia, 48431, Germany

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    Bendorf, 56170, Germany

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    Berlin, 10119, Germany

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    Berlin, 10625, Germany

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    Berlin, 10717, Germany

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    Berlin, 10961, Germany

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    Berlin, 12203, Germany

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    Berlin, 12627, Germany

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    Berlin, 13187, Germany

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    Darmstadt, 64283, Germany

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    Essen, 45127, Germany

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    Fürstenwalde, 15517, Germany

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    Geesthacht, 21502, Germany

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    Giessen, 35392, Germany

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    Halle, 6108, Germany

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    Immenhausen, 34376, Germany

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    Leipzig, 04207, Germany

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    Leipzig, 04299, Germany

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    Leipzig, 04347, Germany

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    Lübeck, 23552, Germany

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    Schleswig, 24837, Germany

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    Exochi, Thessaloniki, 57010, Greece

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    Alexandroupoli, 68100, Greece

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    Athens, 115 21, Greece

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    Ioannina, 45500, Greece

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    Marousi, 151 25, Greece

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    Ashkelon, 7830604, Israel

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    Beer-Yaakov, 703000, Israel

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    Beersheba, 84101, Israel

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    Haifa, 30000, Israel

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    Haifa, 3109601, Israel

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    Haifa, 3436212, Israel

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    Jerusalem, 90000, Israel

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    Jerusalem, 91031, Israel

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    Kfar Saba, 44281, Israel

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    Petah Tikva, 49100, Israel

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    Ramat Gan, 52621, Israel

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    Catania, 95123, Italy

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    Ferrara, 44124, Italy

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    Foggia, 71122, Italy

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    Genova, 16132, Italy

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    Roma, 00128, Italy

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    Roma, 00133, Italy

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    Roma, 00161, Italy

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    Telese Terme, 82037, Italy

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    Daugavpils, LV5410, Latvia

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    Riga, LV 1079, Latvia

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    Riga, LV-1002, Latvia

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    Takapuna, Auckland, 0622, New Zealand

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    Auckland, 1051, New Zealand

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    Auckland, 1051, New Zealand

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    Christchurch, 8023, New Zealand

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    Ebdentown, 5018, New Zealand

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    Hamilton, 3240, New Zealand

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    Rotorua, 3010, New Zealand

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    Oradea, Bihor County, 410155, Romania

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    Oradea, Bihor County, 410176, Romania

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    Timișoara, Timiș County, 300310, Romania

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    Bucharest, 061692, Romania

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    Cluj-Napoca, 400275, Romania

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    Cluj-Napoca, 400371, Romania

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    Constanța, 900002, Romania

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    Seoul, 03181, South Korea

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    Seoul, 5030, South Korea

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    Corby, NN17 2UR, United Kingdom

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    Dagenham, RM9 5NH, United Kingdom

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    Glasgow, G20 7BE, United Kingdom

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    Glasgow, G4 0SF, United Kingdom

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    London, N8 0RA, United Kingdom

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    London, NW10 2PB, United Kingdom

  • GSK Investigational Site

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    Uxbridge, UB8 3NN, United Kingdom

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