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AsthmaPhase 3AGILENCT05243680

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)

A Phase 3 study testing GSK3511294 (Depemokimab) in people with Asthma, run by GlaxoSmithKline at 137 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
GSK3511294 (Depemokimab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
641 participants
Where
137 sitesin 14 countries
Study dates
1 Mar 2022to 19 May 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.
  • Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
  • A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded).
  • Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.
  • Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294.
  • Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result:
  • Alanine aminotransferase (ALT) greater than (>)2 times upper limit of normal (ULN).
Show all 17Show fewer
  • Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<] 35 percent [%]).
  • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
  • Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
  • Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (>=)450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at Visit 1.
  • Current smokers.
  • Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.
  • Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.
  • Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.
  • Other investigational product/clinical study:
  • Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term "investigational" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products.
  • Participants who are currently participating in any other interventional clinical study.

Trial locations and contacts

137 sites in 14 countries.

137 sites in 14 countries

United States29 sites

  • GSK Investigational Site

    Allen, Texas, 75013

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Colorado Springs, Colorado, 80923

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Dallas, Texas, 75225

  • GSK Investigational Site

    DuBois, Pennsylvania, 15801

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Hialeah, Florida, 33013

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Kerrville, Texas, 78028

  • GSK Investigational Site

    Lafayette, Colorado, 80026

  • GSK Investigational Site

    Lancaster, California, 93534

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Loxahatchee Groves, Florida, 33470

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Miami, Florida, 33186

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    Northfield, New Jersey, 08225

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    San Antonio, Texas, 78207

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Toms River, New Jersey, 08755

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan23 sites

  • GSK Investigational Site

    Aichi, 470-1192

  • GSK Investigational Site

    Aichi, 489-8642

  • GSK Investigational Site

    Chiba, 275-8580

  • GSK Investigational Site

    Fukuoka, 802-0052

  • GSK Investigational Site

    Fukuoka, 811-1394

  • GSK Investigational Site

    Fukuoka, 813-0017

  • GSK Investigational Site

    Fukushima, 960-1295

  • GSK Investigational Site

    Hiroshima, 734-8530

  • GSK Investigational Site

    Hokkaido, 053-8506

  • GSK Investigational Site

    Hokkaido, 064-0804

  • GSK Investigational Site

    Kagawa, 761-8073

  • GSK Investigational Site

    Kagawa, 762-8550

  • GSK Investigational Site

    Kagoshima, 890-8520

  • GSK Investigational Site

    Kanagawa, 231-8682

  • GSK Investigational Site

    Kanagawa, 232-0024

  • GSK Investigational Site

    Niigata, 951-8520

  • GSK Investigational Site

    Okayama, 702-8055

  • GSK Investigational Site

    Saga, 843-0393

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 141-8625

  • GSK Investigational Site

    Tokyo, 158-0097

  • GSK Investigational Site

    Tokyo, 185-0014

  • GSK Investigational Site

    Tokyo, 204-8585

Other trials in Japan

China21 sites

  • GSK Investigational Site

    Changchun, 130021

  • GSK Investigational Site

    Changchun, 132011

  • GSK Investigational Site

    Changsha, Hunan, 410013

  • GSK Investigational Site

    Chengdu, 610041

  • GSK Investigational Site

    Guangzhou, 510080

  • GSK Investigational Site

    Guangzhou, 510120

  • GSK Investigational Site

    Guangzhou, 510150

  • GSK Investigational Site

    Guangzhou, 510180

  • GSK Investigational Site

    Haikou, 570311

  • GSK Investigational Site

    Hangzhou, 310009

  • GSK Investigational Site

    Hefei, 230001

  • GSK Investigational Site

    Hohhot, 10017

  • GSK Investigational Site

    Jinan, 250014

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200090

  • GSK Investigational Site

    Shenyang, 110004

  • GSK Investigational Site

    Shenyang, 110016

  • GSK Investigational Site

    Ürümqi, 830054

  • GSK Investigational Site

    Wenzhou, 323027

  • GSK Investigational Site

    Wuhan, 430030

  • GSK Investigational Site

    Xuzhou, 221006

Other trials in China

Italy11 sites

  • GSK Investigational Site

    Brescia, 25123

  • GSK Investigational Site

    Foggia, 71122

  • GSK Investigational Site

    Messina, 98158

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Monserrato CA, 09042

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Pavia, 27100

  • GSK Investigational Site

    Roma, 168

  • GSK Investigational Site

    Rozzano MI, 20089

  • GSK Investigational Site

    Siena, 53100

  • GSK Investigational Site

    Varese, 21049

Other trials in Italy

Spain11 sites

  • GSK Investigational Site

    Barcelona, 08006

  • GSK Investigational Site

    Benalmádena, 29631

  • GSK Investigational Site

    Girona, 17005

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, CP 28041

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46015

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Poland9 sites

  • GSK Investigational Site

    Gdansk, 80-214

  • GSK Investigational Site

    Kielce, 25-355

  • GSK Investigational Site

    Krakow, 30-033

  • GSK Investigational Site

    Krakow, 31-624

  • GSK Investigational Site

    Lodz, 90-242

  • GSK Investigational Site

    Lublin, 20-552

  • GSK Investigational Site

    Ostrowiec Świętokrzyski, 27-400

  • GSK Investigational Site

    Rzeszów, 35-051

  • GSK Investigational Site

    Strzelce Opolskie, 47-120

Other trials in Poland

Germany7 sites

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Frankfurt, 60389

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Koblenz, 56068

  • GSK Investigational Site

    Leipzig, 04275

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Neu-Isenburg, 63263

Other trials in Germany

Czechia6 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Jindřichův Hradec, 377 01

  • GSK Investigational Site

    Strakonice, 38601

  • GSK Investigational Site

    Tábor, 390 02

  • GSK Investigational Site

    Teplice, 415 01

Other trials in Czechia

United Kingdom5 sites

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Chertsey, KT16 0PZ

  • GSK Investigational Site

    London, EC1M 6BQ

  • GSK Investigational Site

    Manchester, M8 5RB

  • GSK Investigational Site

    Nottingham, NG5 1PB

Other trials in United Kingdom

Canada4 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Kamloops, British Columbia, V2C 5T1

  • GSK Investigational Site

    Ottawa, Ontario, K1G 6C6

  • GSK Investigational Site

    Sherwood Park, Alberta, T8H 0N2

Other trials in Canada

France4 sites

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Cholet, 49300

  • GSK Investigational Site

    Marseille, 13015

  • GSK Investigational Site

    Strasbourg, 67091

Other trials in France

Hungary3 sites

  • GSK Investigational Site

    Gödöllő, 2100

  • GSK Investigational Site

    Mosonmagyaróvár, 9200

  • GSK Investigational Site

    Szigetvár, 7900

Other trials in Hungary

Australia2 sites

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    South Brisbane, Queensland, 4101

Other trials in Australia

Taiwan2 sites

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Taichung, 40705

Other trials in Taiwan

About this study

Official title: A Multi-centre, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety of GSK3511294 (Depemokimab) in Adult and Adolescent Participants With Severe Asthma With an Eosinophilic Phenotype From Studies 206713 or 213744

The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.

Conditions
Asthma
Being tested
GSK3511294 (Depemokimab)
Keywords
GSK3511294, Depemokimab, Asthma, Long-term safety, Open-label
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK3511294 (Depemokimab)Biological

    GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.

Study groups in NCT05243680
Study groupRoleWhat they receive
Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)ExperimentalNot described
Receives: Biological: GSK3511294 (Depemokimab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

    Measured: Up to Week 56

  2. Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)

    Serum samples were collected for the determination of anti-GSK3511294 antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive worst case post-Baseline ADA result. Number of participants with worst case post-Baseline positive anti-GSK3511294 antibodies are presented.

    Measured: Up to Week 52

  3. Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies

    Blood samples were collected for the determination of positive neutralizing antibodies. Neutralizing antibody (NAb) test was only carried out on samples that were positive in the confirmatory binding antibody assay. A participant was considered positive for NAb if they had at least one positive worst case post-Baseline neutralizing antibody result. Number of participants with worst case post-Baseline positive neutralizing antibodies are presented.

    Measured: Up to Week 52

Secondary outcomes (4)

  1. Annualized Rate of Clinically Significant Exacerbations

    Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) (such as intramuscular [IM], intravenous [IV] or oral) and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.

    Measured: Up to Week 52

  2. Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score

    The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma symptom control. The questions are designed to be self-completed by the participant. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower score with better asthma control. Baseline was the value at Day 1 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

    Measured: Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 52

  3. Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52

    The SGRQ is a 50-item patient-reported outcome tool used to measure Quality of Life in participants with airway obstruction diseases. The questions are designed to be self-completed by the participant. The total score was calculated by the symptom score, activity and impact score; and summarizing the impact of the disease on overall health status on 0-100 rating scale. Scores are expressed as a percentage of overall impairment where 100 representing worst possible health status and 0 indicating best possible health status. Higher scores indicating greater impairment of quality of life. Baseline was the value at Day 1 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

    Measured: Baseline (Day 1), Weeks 26 and 52

  4. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52

    Forced Expiratory Volume in One Second (FEV1) is a measure of lung function and defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was the value at Day 1 of the study. Change from Baseline in pre-bronchodilator FEV1 was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

    Measured: Baseline (Day 1), Weeks 26 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion19 May 2025
  4. Study completion19 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
641 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243680
Sponsor's protocol ID
212895
Other IDs
2023-505203-23-01, 2023
Acronym
AGILE
Status last verified
Dec 2025
First submitted
8 Feb 2022
Last updated
15 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Wechsler ME, Pfeffer PE, Bernstein DI, Chen R, Koya T, Jackson DJ, Pavord ID, Chanez P, Bourdin A, Jarreta D, Muccino D, Tacon C, Vichiendilokkul A, Zhu CQ, Jackson DJ. Long-term safety and efficacy of twice-yearly depemokimab in type 2 asthma with an eosinophilic phenotype: 2-year integrated analysis of the phase 3a SWIFT-1 and SWIFT-2 studies and AGILE open-label extension. Lancet Respir Med. 2026 Oct 29:S2213-2600(26)00259-6. doi: 10.1016/S2213-2600(26)00259-6. Online ahead of print.

    PubMed 42956801

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK3511294 (Depemokimab) in people with Asthma, run by GlaxoSmithKline at 137 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, Japan, China, Italy, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) (time frame: Up to Week 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243680, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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