NCT05243680CompletedPhase 3
An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
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
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 641 (actual)
- First submitted
- 8 Feb 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 19 May 2025
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Asthma
- NCT number
- NCT05243680
- EU CT number
- 2023-505203-23-01
- EudraCT number
- 2020-004334-38
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 641
- From 1 Mar 2022 to the primary completion date, 19 May 2025
- 129 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
- 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.
Other illness
- 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 allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.
Lab values
- 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).
- 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.
- 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.
Other
- 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.
- Current smokers.
- Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (129)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Ajax | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Kamloops | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Sherwood Park | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| - Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| - Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| - Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| - Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| - Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| MEDITRIAL s.r.o. Coordinator of this site? Confirm its status | Jindrichuv Hradec III | Czechia | Completed |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Completed |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Completed |
| MUDr. Jaroslav Mareš Coordinator of this site? Confirm its status | Strakonice | Czechia | Completed |
| KASMED s.r.o. Coordinator of this site? Confirm its status | Tábor | Czechia | Completed |
| Plicni Stredisko Teplice S.R.O Coordinator of this site? Confirm its status | Teplice | Czechia | Completed |
| KPPK GmbH Coordinator of this site? Confirm its status | Bendorf | Germany | Completed |
| Studienzentrum Dr. med. Claus Keller Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Completed |
| ME Clinical Respiratory Research Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| POIS Sachsen GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| SMO.MD GmbH Coordinator of this site? Confirm its status | Magdeburg | Germany | Completed |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Ballenberger, Freytag, Wenisch Coordinator of this site? Confirm its status | Neu-Isenburg | Germany | Completed |
| UOMI Cancer Center-Clinica Tres Torres Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Giromed Institute S.L.P. Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Vithas Xanit Internacional Coordinator of this site? Confirm its status | Benalmádena | Spain | Completed |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Completed |
| Giromed Institute S.L.P. Coordinator of this site? Confirm its status | Girona | Spain | Completed |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Completed |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Arnau de Vilanova de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| Centre Hospitalier De Cannes Simone Veil Coordinator of this site? Confirm its status | Cannes Cedex | France | Completed |
| Centre Hospitalier de Cholet Coordinator of this site? Confirm its status | Cholet | France | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Completed |
| - Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Erzsebet Gondozohaz Kft. Coordinator of this site? Confirm its status | Gödöllő | Hungary | Completed |
| Omnimodus Elixír Kft. Coordinator of this site? Confirm its status | Mosonmagyaróvár | Hungary | Completed |
| Spiroped Szigetvar Kft. Coordinator of this site? Confirm its status | Szigetvar | Hungary | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Completed |
| Università degli Studi di Messina Coordinator of this site? Confirm its status | Messina | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera Universitaria Di Cagliari Coordinator of this site? Confirm its status | Monserrato | Italy | Completed |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Azienda Ospedaliera Universitaria Senese Coordinator of this site? Confirm its status | Siena | Italy | Completed |
| Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb Coordinator of this site? Confirm its status | Tradate | Italy | Completed |
| - Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kagawa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Malopolskie Centrum Alergologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Polimedica Centrum Badan Profilaktyki I Leczenia Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Kielce | Poland | Completed |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Alergologii Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c. Coordinator of this site? Confirm its status | Ostrowiec Świętokrzyski | Poland | Completed |
| Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| Lekarze Specjalisci - J. Malolepszy I Partnerzy Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Coordinator of this site? Confirm its status | Wrocław | Poland | Completed |
| Centrum Medyczne Lucyna Andrzej Dymek s.c. Coordinator of this site? Confirm its status | Zawadzkie | Poland | Completed |
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Allen | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Bellingham | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boerne | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | DuBois | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Gastonia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Kerrville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Loxahatchee Groves | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Normal | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Northfield | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| - Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
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