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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Biological: GSK3511294 (Depemokimab)

• Study Type: Interventional
• Enrollment (Actual): 641
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • GSK Investigational Site
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • GSK Investigational Site
• Canada
  • Alberta
    • Sherwood Park, Alberta, Canada, T8H 0N2
      • GSK Investigational Site
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C 5T1
      • GSK Investigational Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • GSK Investigational Site
    • Ottawa, Ontario, Canada, K1G 6C6
      • GSK Investigational Site
• China
  • Changchun, China, 130021
    • GSK Investigational Site
  • Changchun, China, 132011
    • GSK Investigational Site
  • Chengdu, China, 610041
    • GSK Investigational Site
  • Guangzhou, China, 510080
    • GSK Investigational Site
  • Guangzhou, China, 510120
    • GSK Investigational Site
  • Guangzhou, China, 510150
    • GSK Investigational Site
  • Guangzhou, China, 510180
    • GSK Investigational Site
  • Haikou, China, 570311
    • GSK Investigational Site
  • Hangzhou, China, 310009
    • GSK Investigational Site
  • Hefei, China, 230001
    • GSK Investigational Site
  • Hohhot, China, 10017
    • GSK Investigational Site
  • Jinan, China, 250014
    • GSK Investigational Site
  • Shanghai, China, 200040
    • GSK Investigational Site
  • Shanghai, China, 200090
    • GSK Investigational Site
  • Shenyang, China, 110004
    • GSK Investigational Site
  • Shenyang, China, 110016
    • GSK Investigational Site
  • Wenzhou, China, 323027
    • GSK Investigational Site
  • Wuhan, China, 430030
    • GSK Investigational Site
  • Xuzhou, China, 221006
    • GSK Investigational Site
  • Ürümqi, China, 830054
    • GSK Investigational Site
  • Hunan
    • Changsha, Hunan, China, 410013
      • GSK Investigational Site
• Czechia
  • Brno, Czechia, 625 00
    • GSK Investigational Site
  • Hradec Králové, Czechia, 500 05
    • GSK Investigational Site
  • Jindřichův Hradec, Czechia, 377 01
    • GSK Investigational Site
  • Strakonice, Czechia, 38601
    • GSK Investigational Site
  • Teplice, Czechia, 415 01
    • GSK Investigational Site
  • Tábor, Czechia, 390 02
    • GSK Investigational Site
• France
  • Caen, France, 14033
    • GSK Investigational Site
  • Cholet, France, 49300
    • GSK Investigational Site
  • Marseille, France, 13015
    • GSK Investigational Site
  • Strasbourg, France, 67091
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10367
    • GSK Investigational Site
  • Frankfurt, Germany, 60389
    • GSK Investigational Site
  • Hamburg, Germany, 22299
    • GSK Investigational Site
  • Koblenz, Germany, 56068
    • GSK Investigational Site
  • Leipzig, Germany, 04275
    • GSK Investigational Site
  • Magdeburg, Germany, 39120
    • GSK Investigational Site
  • Neu-Isenburg, Germany, 63263
    • GSK Investigational Site
• Hungary
  • Gödöllő, Hungary, 2100
    • GSK Investigational Site
  • Mosonmagyaróvár, Hungary, 9200
    • GSK Investigational Site
  • Szigetvár, Hungary, 7900
    • GSK Investigational Site
• Italy
  • Brescia, Italy, 25123
    • GSK Investigational Site
  • Foggia, Italy, 71122
    • GSK Investigational Site
  • Messina, Italy, 98158
    • GSK Investigational Site
  • Milan, Italy, 20122
    • GSK Investigational Site
  • Monserrato CA, Italy, 09042
    • GSK Investigational Site
  • Palermo, Italy, 90127
    • GSK Investigational Site
  • Pavia, Italy, 27100
    • GSK Investigational Site
  • Roma, Italy, 168
    • GSK Investigational Site
  • Rozzano MI, Italy, 20089
    • GSK Investigational Site
  • Siena, Italy, 53100
    • GSK Investigational Site
  • Varese, Italy, 21049
    • GSK Investigational Site
• Japan
  • Aichi, Japan, 470-1192
    • GSK Investigational Site
  • Aichi, Japan, 489-8642
    • GSK Investigational Site
  • Chiba, Japan, 275-8580
    • GSK Investigational Site
  • Fukuoka, Japan, 802-0052
    • GSK Investigational Site
  • Fukuoka, Japan, 811-1394
    • GSK Investigational Site
  • Fukuoka, Japan, 813-0017
    • GSK Investigational Site
  • Fukushima, Japan, 960-1295
    • GSK Investigational Site
  • Hiroshima, Japan, 734-8530
    • GSK Investigational Site
  • Hokkaido, Japan, 053-8506
    • GSK Investigational Site
  • Hokkaido, Japan, 064-0804
    • GSK Investigational Site
  • Kagawa, Japan, 761-8073
    • GSK Investigational Site
  • Kagawa, Japan, 762-8550
    • GSK Investigational Site
  • Kagoshima, Japan, 890-8520
    • GSK Investigational Site
  • Kanagawa, Japan, 232-0024
    • GSK Investigational Site
  • Kanagawa, Japan, 231-8682
    • GSK Investigational Site
  • Niigata, Japan, 951-8520
    • GSK Investigational Site
  • Okayama, Japan, 702-8055
    • GSK Investigational Site
  • Saga, Japan, 843-0393
    • GSK Investigational Site
  • Tokyo, Japan, 103-0027
    • GSK Investigational Site
  • Tokyo, Japan, 185-0014
    • GSK Investigational Site
  • Tokyo, Japan, 141-8625
    • GSK Investigational Site
  • Tokyo, Japan, 158-0097
    • GSK Investigational Site
  • Tokyo, Japan, 204-8585
    • GSK Investigational Site
• Poland
  • Gdansk, Poland, 80-214
    • GSK Investigational Site
  • Kielce, Poland, 25-355
    • GSK Investigational Site
  • Krakow, Poland, 30-033
    • GSK Investigational Site
  • Krakow, Poland, 31-624
    • GSK Investigational Site
  • Lodz, Poland, 90-242
    • GSK Investigational Site
  • Lublin, Poland, 20-552
    • GSK Investigational Site
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • GSK Investigational Site
  • Rzeszów, Poland, 35-051
    • GSK Investigational Site
  • Strzelce Opolskie, Poland, 47-120
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08006
    • GSK Investigational Site
  • Benalmádena, Spain, 29631
    • GSK Investigational Site
  • Girona, Spain, 17005
    • GSK Investigational Site
  • Granada, Spain, 18014
    • GSK Investigational Site
  • Madrid, Spain, 28031
    • GSK Investigational Site
  • Madrid, Spain, CP 28041
    • GSK Investigational Site
  • Palma de Mallorca, Spain, 07010
    • GSK Investigational Site
  • Pozuelo de AlarcOn Madr, Spain, 28223
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
  • Valencia, Spain, 46015
    • GSK Investigational Site
  • Zaragoza, Spain, 50009
    • GSK Investigational Site
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • GSK Investigational Site
  • Taichung, Taiwan, 40705
    • GSK Investigational Site
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • GSK Investigational Site
  • Chertsey, United Kingdom, KT16 0PZ
    • GSK Investigational Site
  • London, United Kingdom, EC1M 6BQ
    • GSK Investigational Site
  • Manchester, United Kingdom, M8 5RB
    • GSK Investigational Site
  • Nottingham, United Kingdom, NG5 1PB
    • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
  • California
    • Lancaster, California, United States, 93534
      • GSK Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • GSK Investigational Site
    • Lafayette, Colorado, United States, 80026
      • GSK Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • GSK Investigational Site
    • Hialeah, Florida, United States, 33013
      • GSK Investigational Site
    • Loxahatchee Groves, Florida, United States, 33470
      • GSK Investigational Site
    • Miami, Florida, United States, 33173
      • GSK Investigational Site
    • Miami, Florida, United States, 33144
      • GSK Investigational Site
    • Miami, Florida, United States, 33186
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
  • Georgia
    • Savannah, Georgia, United States, 31406
      • GSK Investigational Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • GSK Investigational Site
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • GSK Investigational Site
  • New Jersey
    • Northfield, New Jersey, United States, 08225
      • GSK Investigational Site
    • Toms River, New Jersey, United States, 08755
      • GSK Investigational Site
  • New York
    • The Bronx, New York, United States, 10461
      • GSK Investigational Site
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • GSK Investigational Site
    • Huntersville, North Carolina, United States, 28078
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • GSK Investigational Site
  • Texas
    • Allen, Texas, United States, 75013
      • GSK Investigational Site
    • Boerne, Texas, United States, 78006
      • GSK Investigational Site
    • Dallas, Texas, United States, 75225
      • GSK Investigational Site
    • Kerrville, Texas, United States, 78028
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78207
      • GSK Investigational Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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:

  1. Alanine aminotransferase (ALT) greater than (>)2 times upper limit of normal (ULN).
  2. 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 [%]).
  3. 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:

  1. 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.
  2. Participants who are currently participating in any other interventional clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)	Biological: GSK3511294 (Depemokimab); GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Week 56
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.	Up to Week 52
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.	Up to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Week 52
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.	Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 52
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.	Baseline (Day 1), Weeks 26 and 52
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.	Baseline (Day 1), Weeks 26 and 52

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: IQVIA Pty Ltd
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 19, 2025
• Study Completion (Actual): May 19, 2025

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; Open-label; Long-term safety; Depemokimab; GSK3511294
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 212895; 2023-505203-23-01 (Other Identifier: EU-CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No