Asthma Clinical Trial
— NIMBLEOfficial title:
A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab
This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.
| Status | Recruiting |
| Enrollment | 1700 |
| Est. completion date | September 26, 2025 |
| Est. primary completion date | September 26, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Key inclusion criteria for study: - Adult and adolescent participants more than or equal to (>=)12 years of age, at the time of signing the informed consent/assent. - Participants who have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines. - Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for >=12 months prior to screening and have a documented benefit to therapy assessed by either: (i) >=50% reduction in exacerbation frequency since initiating treatment, or (ii) >=50% reduction in maintenance OCS use since initiating treatment, or (iii) No exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (<=)1.5 at screening. - A well-documented requirement for regular treatment with medium to high dose ICS in the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS dose must be >=440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane (HFA) product daily, or clinically comparable. Participants who are treated with medium dose ICS will also need to be treated with a LABA to qualify for inclusion. - Current treatment with at least one additional controller medication, besides ICS [for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline]. Key exclusion criteria for study: - Participants with presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. - Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis. - A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded). - 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 excluded prior to enrolment. - Participants who have received Omalizumab (Xolair), dupilumab (Dupixent) or reslizumab (Cinqair/Cinqaero) within 130 days prior to Visit 1. - Participants who have received any Monoclonal antibody (mAb) within 5 half-lives of Visit 1. - Corrected QT interval using Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1. - Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years equal to [number of cigarettes per day/20] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1. - Participants with allergy/intolerance to a mAb or biologic. Key exclusion criteria for randomization: - Evidence of a clinically significant abnormality in the 12-lead electrocardiogram (ECG) over-read conducted at Screening Visit 1, based on the evaluation of the investigator, or QTcF >=450 msec or QTcF >=480 msec for participants with Bundle Branch Block, at randomization Visit 2. - Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable. If the 8-week screening period has elapsed, then the participant should be considered a run-in failure. - Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | GSK Investigational Site | Adelaide | South Australia |
| Australia | GSK Investigational Site | Bedford Park | South Australia |
| Australia | GSK Investigational Site | Box Hill | Victoria |
| Australia | GSK Investigational Site | Cairns | Queensland |
| Australia | GSK Investigational Site | Clayton | Victoria |
| Australia | GSK Investigational Site | Fitzroy | Victoria |
| Australia | GSK Investigational Site | Frankston | Victoria |
| Australia | GSK Investigational Site | Macquarie University | New South Wales |
| Australia | GSK Investigational Site | Nedlands | Western Australia |
| Australia | GSK Investigational Site | North Adelaide | South Australia |
| Australia | GSK Investigational Site | Prahran | Victoria |
| Australia | GSK Investigational Site | South Brisbane | Queensland |
| Australia | GSK Investigational Site | South Brisbane | Queensland |
| Australia | GSK Investigational Site | Sydney | New South Wales |
| Australia | GSK Investigational Site | Toorak Gardens | South Australia |
| Australia | GSK Investigational Site | Westmead | New South Wales |
| Australia | GSK Investigational Site | Woodville South | South Australia |
| Austria | GSK Investigational Site | Feldbach | |
| Austria | GSK Investigational Site | Wien | |
| Canada | GSK Investigational Site | Ajax | Ontario |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Edmonton | Alberta |
| Canada | GSK Investigational Site | Greenfield Park | Quebec |
| Canada | GSK Investigational Site | Moncton | New Brunswick |
| Canada | GSK Investigational Site | Ottawa | Ontario |
| Canada | GSK Investigational Site | Pierrefonds | Quebec |
| Canada | GSK Investigational Site | Quebec | |
| Canada | GSK Investigational Site | Quebec City | Quebec |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Trois-Rivieres | Quebec |
| Canada | GSK Investigational Site | Windsor | Ontario |
| Finland | GSK Investigational Site | Tampere | |
| Finland | GSK Investigational Site | Turku | |
| France | GSK Investigational Site | Amiens | |
| France | GSK Investigational Site | Annecy Cedex | |
| France | GSK Investigational Site | Antony | |
| France | GSK Investigational Site | Besançon | |
| France | GSK Investigational Site | Brest Cedex | |
| France | GSK Investigational Site | Brest cedex | |
| France | GSK Investigational Site | Caen | |
| France | GSK Investigational Site | Cannes Cedex | |
| France | GSK Investigational Site | Cholet | |
| France | GSK Investigational Site | Dijon Cedex | |
| France | GSK Investigational Site | La Tronche | |
| France | GSK Investigational Site | Le Mans Cedex | |
| France | GSK Investigational Site | Lille Cedex | |
| France | GSK Investigational Site | Lille cedex | |
| France | GSK Investigational Site | Lyon cedex 04 | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Montfermeil | |
| France | GSK Investigational Site | Montivilliers | |
| France | GSK Investigational Site | Montpellier Cedex 5 | |
| France | GSK Investigational Site | Nantes cedex | |
| France | GSK Investigational Site | Nice cedex 1 | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris cedex 15 | |
| France | GSK Investigational Site | Paris Cedex 18 | |
| France | GSK Investigational Site | Pontoise | |
| France | GSK Investigational Site | Rouen cedex | |
| France | GSK Investigational Site | Strasbourg | |
| France | GSK Investigational Site | Suresnes | |
| France | GSK Investigational Site | Toulouse | |
| France | GSK Investigational Site | Tours cedex 9 | |
| Germany | GSK Investigational Site | Aschaffenburg | Bayern |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Bonn | |
| Germany | GSK Investigational Site | Bonn | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Darmstadt | Hessen |
| Germany | GSK Investigational Site | Frankfurt | Hessen |
| Germany | GSK Investigational Site | Frankfurt | Hessen |
| Germany | GSK Investigational Site | Fuerstenwalde | Brandenburg |
| Germany | GSK Investigational Site | Geesthacht | Schleswig-Holstein |
| Germany | GSK Investigational Site | Halle | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Halle | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hannover | Niedersachsen |
| Germany | GSK Investigational Site | Heidelberg | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Koblenz | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Landsberg | Bayern |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Luebeck | Schleswig-Holstein |
| Germany | GSK Investigational Site | Luebeck | Schleswig-Holstein |
| Germany | GSK Investigational Site | Magdeburg | |
| Germany | GSK Investigational Site | Mainz | Rheinland-Pfalz |
| Germany | GSK Investigational Site | München | Bayern |
| Germany | GSK Investigational Site | Neu isenburg | Hessen |
| Germany | GSK Investigational Site | Rheine | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Schleswig | Schleswig-Holstein |
| Germany | GSK Investigational Site | Weissenburg | Bayern |
| Ireland | GSK Investigational Site | Cork | |
| Ireland | GSK Investigational Site | Dublin | |
| Ireland | GSK Investigational Site | Dublin | |
| Israel | GSK Investigational Site | Beer Sheva | |
| Israel | GSK Investigational Site | Haifa | |
| Israel | GSK Investigational Site | Jerusalem | |
| Israel | GSK Investigational Site | Jerusalem | |
| Israel | GSK Investigational Site | Kfar Saba | |
| Israel | GSK Investigational Site | Petah Tikva | |
| Israel | GSK Investigational Site | Ramat-Gan | |
| Israel | GSK Investigational Site | Tel Aviv | |
| Israel | GSK Investigational Site | Zrifin | |
| Italy | GSK Investigational Site | Ancona | Marche |
| Italy | GSK Investigational Site | Bari | Puglia |
| Italy | GSK Investigational Site | Bari | Puglia |
| Italy | GSK Investigational Site | Bergamo | Lombardia |
| Italy | GSK Investigational Site | Bologna | Emilia-Romagna |
| Italy | GSK Investigational Site | Brescia | Lombardia |
| Italy | GSK Investigational Site | Catania | Sicilia |
| Italy | GSK Investigational Site | Cona | Emilia-Romagna |
| Italy | GSK Investigational Site | Firenze | Toscana |
| Italy | GSK Investigational Site | Genova | Liguria |
| Italy | GSK Investigational Site | Mantova | Lombardia |
| Italy | GSK Investigational Site | Milano | Lombardia |
| Italy | GSK Investigational Site | Milano | Lombardia |
| Italy | GSK Investigational Site | Milano | Lombardia |
| Italy | GSK Investigational Site | Milano | Lombardia |
| Italy | GSK Investigational Site | Modena | Emilia-Romagna |
| Italy | GSK Investigational Site | Monserrato | Sardegna |
| Italy | GSK Investigational Site | Napoli | Campania |
| Italy | GSK Investigational Site | Padova | |
| Italy | GSK Investigational Site | Palermo | Sicilia |
| Italy | GSK Investigational Site | Pavia | Lombardia |
| Italy | GSK Investigational Site | Perugia | Umbria |
| Italy | GSK Investigational Site | Pisa | Toscana |
| Italy | GSK Investigational Site | Reggio Emilia | Emilia-Romagna |
| Italy | GSK Investigational Site | Roma | Lazio |
| Italy | GSK Investigational Site | Salerno | Campania |
| Italy | GSK Investigational Site | Salerno | Campania |
| Italy | GSK Investigational Site | Sassari | Sardegna |
| Italy | GSK Investigational Site | Siena | Toscana |
| Italy | GSK Investigational Site | Torino | Piemonte |
| Italy | GSK Investigational Site | Treviso | Veneto |
| Italy | GSK Investigational Site | Trieste | Friuli-Venezia-Giulia |
| Italy | GSK Investigational Site | Verona | Veneto |
| Japan | GSK Investigational Site | Aichi | |
| Japan | GSK Investigational Site | Aichi | |
| Japan | GSK Investigational Site | Aichi | |
| Japan | GSK Investigational Site | Akita | |
| Japan | GSK Investigational Site | Ehime | |
| Japan | GSK Investigational Site | Fukuoka | |
| Japan | GSK Investigational Site | Fukuoka | |
| Japan | GSK Investigational Site | Fukuoka | |
| Japan | GSK Investigational Site | Fukuoka | |
| Japan | GSK Investigational Site | Fukuoka | |
| Japan | GSK Investigational Site | Fukuoka | |
| Japan | GSK Investigational Site | Fukushima | |
| Japan | GSK Investigational Site | Gifu | |
| Japan | GSK Investigational Site | Hiroshima | |
| Japan | GSK Investigational Site | Hiroshima | |
| Japan | GSK Investigational Site | Hiroshima | |
| Japan | GSK Investigational Site | Hokkaido | |
| Japan | GSK Investigational Site | Hokkaido | |
| Japan | GSK Investigational Site | Hyogo | |
| Japan | GSK Investigational Site | Hyogo | |
| Japan | GSK Investigational Site | Ibaraki | |
| Japan | GSK Investigational Site | Ibaraki | |
| Japan | GSK Investigational Site | Ishikawa | |
| Japan | GSK Investigational Site | Iwate | |
| Japan | GSK Investigational Site | Kagawa | |
| Japan | GSK Investigational Site | Kagoshima | |
| Japan | GSK Investigational Site | Kanagawa | |
| Japan | GSK Investigational Site | Kanagawa | |
| Japan | GSK Investigational Site | Kanagawa | |
| Japan | GSK Investigational Site | Kanagawa | |
| Japan | GSK Investigational Site | Kanagawa | |
| Japan | GSK Investigational Site | Mie | |
| Japan | GSK Investigational Site | Mie | |
| Japan | GSK Investigational Site | Mie | |
| Japan | GSK Investigational Site | Miyagi | |
| Japan | GSK Investigational Site | Nagano | |
| Japan | GSK Investigational Site | Niigata | |
| Japan | GSK Investigational Site | Okayama | |
| Japan | GSK Investigational Site | Okayama | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Shimane | |
| Japan | GSK Investigational Site | Shizuoka | |
| Japan | GSK Investigational Site | Shizuoka | |
| Japan | GSK Investigational Site | Tochigi | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Tokyo | |
| Japan | GSK Investigational Site | Toyama | |
| Japan | GSK Investigational Site | Wakayama | |
| Netherlands | GSK Investigational Site | Arnhem | |
| Netherlands | GSK Investigational Site | Breda | |
| Netherlands | GSK Investigational Site | Deventer | |
| Netherlands | GSK Investigational Site | Eindhoven | |
| Netherlands | GSK Investigational Site | Enschede | |
| Netherlands | GSK Investigational Site | Harderwijk | |
| Netherlands | GSK Investigational Site | Leeuwarden | |
| Netherlands | GSK Investigational Site | Nijmegen | |
| Netherlands | GSK Investigational Site | Rotterdam | |
| Netherlands | GSK Investigational Site | Zwolle | |
| Norway | GSK Investigational Site | Bergen | |
| Norway | GSK Investigational Site | Lørenskog | |
| Portugal | GSK Investigational Site | Coimbra | |
| Portugal | GSK Investigational Site | Guarda | |
| Portugal | GSK Investigational Site | Lisboa | |
| Portugal | GSK Investigational Site | Matosinhos | |
| Portugal | GSK Investigational Site | Porto | |
| Puerto Rico | GSK Investigational Site | Guaynabo | |
| Slovenia | GSK Investigational Site | Golnik | |
| Spain | GSK Investigational Site | Alcorcón (Madrid) | |
| Spain | GSK Investigational Site | Almería | |
| Spain | GSK Investigational Site | Badalona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Basurto/Bilbao | |
| Spain | GSK Investigational Site | Benalmádena | |
| Spain | GSK Investigational Site | Elche | |
| Spain | GSK Investigational Site | Esplugues de Llobregat | |
| Spain | GSK Investigational Site | Granada | |
| Spain | GSK Investigational Site | Jerez de la Frontera | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Málaga | |
| Spain | GSK Investigational Site | Málaga | |
| Spain | GSK Investigational Site | Mérida (Badajoz) | |
| Spain | GSK Investigational Site | Pamplona | |
| Spain | GSK Investigational Site | Pozuelo De Alarcón | Madrid |
| Spain | GSK Investigational Site | Salamanca | |
| Spain | GSK Investigational Site | Sán Crístobál De Lá Láguná | |
| Spain | GSK Investigational Site | Santander | |
| Spain | GSK Investigational Site | Santiago De Compostela. La Coruña. | |
| Spain | GSK Investigational Site | Valencia | |
| Spain | GSK Investigational Site | Valencia | |
| Spain | GSK Investigational Site | Via-Real (Castellón) | |
| Spain | GSK Investigational Site | Vitoria - Gasteiz | |
| Spain | GSK Investigational Site | Zaragoza | |
| Sweden | GSK Investigational Site | Linköping | |
| Sweden | GSK Investigational Site | Lund | |
| Sweden | GSK Investigational Site | Östersund | |
| Sweden | GSK Investigational Site | Stockholm | |
| Sweden | GSK Investigational Site | Uppsala | |
| Switzerland | GSK Investigational Site | Aarau | |
| Switzerland | GSK Investigational Site | Basel | |
| Switzerland | GSK Investigational Site | Liestal | |
| Switzerland | GSK Investigational Site | St. Gallen | |
| Taiwan | GSK Investigational Site | Changhua | |
| Taiwan | GSK Investigational Site | Gueishan Township,Taoyuan County | |
| Taiwan | GSK Investigational Site | Taichung | |
| Taiwan | GSK Investigational Site | Taichung | |
| Taiwan | GSK Investigational Site | Taipei | |
| Taiwan | GSK Investigational Site | Taipei | |
| United Kingdom | GSK Investigational Site | Airdrie | Lanarkshire |
| United Kingdom | GSK Investigational Site | Belfast | |
| United Kingdom | GSK Investigational Site | Birmingham | |
| United Kingdom | GSK Investigational Site | Bradford | |
| United Kingdom | GSK Investigational Site | Bristol | Gloucestershire |
| United Kingdom | GSK Investigational Site | Cottingham, East Yorkshire | |
| United Kingdom | GSK Investigational Site | Edinburgh | |
| United Kingdom | GSK Investigational Site | Exeter. | |
| United Kingdom | GSK Investigational Site | Glasgow | |
| United Kingdom | GSK Investigational Site | Glasgow | |
| United Kingdom | GSK Investigational Site | Liverpool | Merseyside |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | Newcastle Upon Tyne | |
| United Kingdom | GSK Investigational Site | Nottingham | Nottinghamshire |
| United Kingdom | GSK Investigational Site | Oxford | |
| United Kingdom | GSK Investigational Site | Portsmouth | |
| United Kingdom | GSK Investigational Site | Preston | |
| United Kingdom | GSK Investigational Site | Wakefield | |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Altoona | Pennsylvania |
| United States | GSK Investigational Site | Amarillo | Texas |
| United States | GSK Investigational Site | Amarillo | Texas |
| United States | GSK Investigational Site | Ann Arbor | Michigan |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Aurora | Colorado |
| United States | GSK Investigational Site | Aventura | Florida |
| United States | GSK Investigational Site | Bakersfield | California |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Bangor | Maine |
| United States | GSK Investigational Site | Bellingham | Washington |
| United States | GSK Investigational Site | Bethlehem | Pennsylvania |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Brick | New Jersey |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Burlington | Massachusetts |
| United States | GSK Investigational Site | Calhoun | Georgia |
| United States | GSK Investigational Site | Chesterfield | Missouri |
| United States | GSK Investigational Site | Chevy Chase | Maryland |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Corvallis | Oregon |
| United States | GSK Investigational Site | Cypress | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dearborn | Michigan |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | DuBois | Pennsylvania |
| United States | GSK Investigational Site | Encinitas | California |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Flint | Michigan |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Gainesville | Florida |
| United States | GSK Investigational Site | Greenfield | Wisconsin |
| United States | GSK Investigational Site | Happy Valley | Oregon |
| United States | GSK Investigational Site | Hendersonville | Tennessee |
| United States | GSK Investigational Site | Hershey | Pennsylvania |
| United States | GSK Investigational Site | Horseheads | New York |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Huntersville | North Carolina |
| United States | GSK Investigational Site | Huntington Beach | California |
| United States | GSK Investigational Site | Jackson | Mississippi |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Kerrville | Texas |
| United States | GSK Investigational Site | Kissimmee | Florida |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | La Jolla | California |
| United States | GSK Investigational Site | Lakewood | Colorado |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Lincoln | Nebraska |
| United States | GSK Investigational Site | Litchfield Park | Arizona |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Loxahatchee Groves | Florida |
| United States | GSK Investigational Site | McAllen | Texas |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami Lakes | Florida |
| United States | GSK Investigational Site | Miami Lakes | Florida |
| United States | GSK Investigational Site | Miami Lakes | Florida |
| United States | GSK Investigational Site | Miami Lakes | Florida |
| United States | GSK Investigational Site | Miami Springs | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | Murray | Utah |
| United States | GSK Investigational Site | New Bedford | Massachusetts |
| United States | GSK Investigational Site | New Haven | Connecticut |
| United States | GSK Investigational Site | New Hyde Park | New York |
| United States | GSK Investigational Site | Newport Beach | California |
| United States | GSK Investigational Site | North Dartmouth | Massachusetts |
| United States | GSK Investigational Site | North Palm Beach | Florida |
| United States | GSK Investigational Site | Northfield | Illinois |
| United States | GSK Investigational Site | Northfield | New Jersey |
| United States | GSK Investigational Site | Northridge | California |
| United States | GSK Investigational Site | Oak Park | Illinois |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Overland Park | Kansas |
| United States | GSK Investigational Site | Owensboro | Kentucky |
| United States | GSK Investigational Site | Oxnard | California |
| United States | GSK Investigational Site | Pensacola | Florida |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Rancho Cucamonga | California |
| United States | GSK Investigational Site | Redondo Beach | California |
| United States | GSK Investigational Site | Redwood City | California |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Rio Rancho | New Mexico |
| United States | GSK Investigational Site | Riverdale | New Jersey |
| United States | GSK Investigational Site | Rock Hill | South Carolina |
| United States | GSK Investigational Site | Saint Charles | Missouri |
| United States | GSK Investigational Site | Saint Louis | Missouri |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Santa Monica | California |
| United States | GSK Investigational Site | Scottsboro | Alabama |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Seattle | Washington |
| United States | GSK Investigational Site | Sebring | Florida |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | Skokie | Illinois |
| United States | GSK Investigational Site | Spartanburg | South Carolina |
| United States | GSK Investigational Site | Stafford | Texas |
| United States | GSK Investigational Site | Stonecrest | Georgia |
| United States | GSK Investigational Site | Tallahassee | Florida |
| United States | GSK Investigational Site | Tarzana | California |
| United States | GSK Investigational Site | Toms River | New Jersey |
| United States | GSK Investigational Site | Upland | California |
| United States | GSK Investigational Site | Warren | Michigan |
| United States | GSK Investigational Site | Warwick | Rhode Island |
| United States | GSK Investigational Site | Waxahachie | Texas |
| United States | GSK Investigational Site | West Bloomfield | Michigan |
| United States | GSK Investigational Site | Wheat Ridge | Colorado |
| United States | GSK Investigational Site | White Marsh | Maryland |
| United States | GSK Investigational Site | Williamsburg | Virginia |
| United States | GSK Investigational Site | Wilmington | North Carolina |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| United States | GSK Investigational Site | Woodland | California |
| United States | GSK Investigational Site | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline | Iqvia Pty Ltd |
United States, Australia, Austria, Canada, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, Portugal, Puerto Rico, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualized rate of clinically significant exacerbations over 52 weeks | Clinically significant exacerbations of asthma are defined by worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visit. Annualized rate of exacerbations will be calculated as number of exacerbations experienced by the participant divided by the length of time the participant is measured on. | Up to Week 52 | |
| Secondary | Weighted mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score | The SGRQ is a well-established instrument, comprising 51 questions designed to measure Quality of Life in participants with diseases of airway obstruction. Higher score indicates worse quality of life. | Baseline (Day 1) and up to Week 52 | |
| Secondary | Weighted mean change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score | The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control that can be quickly and easily completed. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale. Higher score indicates more limitations. | Baseline (Day 1) and up to Week 52 | |
| Secondary | Weighted mean change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) | FEV1 is a measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 will be measured using spirometry. | Baseline (Day 1) and up to Week 52 |
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