An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
NCT ID: NCT05243680
Last Updated: 2026-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
641 participants
INTERVENTIONAL
2022-03-01
2025-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.
Interventions
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GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Lancaster, California, United States
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Colorado Springs, Colorado, United States
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Lafayette, Colorado, United States
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Coral Gables, Florida, United States
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Hialeah, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Savannah, Georgia, United States
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Normal, Illinois, United States
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Lexington, Kentucky, United States
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Ypsilanti, Michigan, United States
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Northfield, New Jersey, United States
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Toms River, New Jersey, United States
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The Bronx, New York, United States
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Gastonia, North Carolina, United States
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Huntersville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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DuBois, Pennsylvania, United States
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Allen, Texas, United States
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Boerne, Texas, United States
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Dallas, Texas, United States
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Kerrville, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Bellingham, Washington, United States
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Coffs Harbour, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Sherwood Park, Alberta, Canada
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Kamloops, British Columbia, Canada
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Ajax, Ontario, Canada
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Ottawa, Ontario, Canada
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Changsha, Hunan, China
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Changchun, , China
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Changchun, , China
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Chengdu, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Hefei, , China
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Hohhot, , China
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Jinan, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Ürümqi, , China
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Wenzhou, , China
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Wuhan, , China
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Xuzhou, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Jindřichův Hradec, , Czechia
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Strakonice, , Czechia
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Tábor, , Czechia
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Teplice, , Czechia
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Caen, , France
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Cholet, , France
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Marseille, , France
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Strasbourg, , France
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Berlin, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Koblenz, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Neu-Isenburg, , Germany
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Gödöllő, , Hungary
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Mosonmagyaróvár, , Hungary
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Szigetvár, , Hungary
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Brescia, , Italy
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Foggia, , Italy
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Messina, , Italy
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Milan, , Italy
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Monserrato CA, , Italy
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Palermo, , Italy
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Pavia, , Italy
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Roma, , Italy
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Rozzano MI, , Italy
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Siena, , Italy
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Varese, , Italy
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Aichi, , Japan
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Aichi, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Hokkaido, , Japan
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Kagawa, , Japan
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Kagawa, , Japan
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Kagoshima, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Saga, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Gdansk, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Ostrowiec Świętokrzyski, , Poland
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Rzeszów, , Poland
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Strzelce Opolskie, , Poland
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Barcelona, , Spain
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Benalmádena, , Spain
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Girona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Pozuelo de AlarcOn Madr, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Bradford, , United Kingdom
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Chertsey, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
GSK Investigational Site
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2023-505203-23-01
Identifier Type: OTHER
Identifier Source: secondary_id
212895
Identifier Type: -
Identifier Source: org_study_id
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