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NCT06750289PHASE3Recruiting

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

AstraZeneca

Start Date

3/28/2025

Completion Date

11/3/2028

Summary

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Detailed Description

This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).

Eligibility Criteria

Age Range: 12 years to 75 years

Inclusion Criteria: * Written informed consent * Participant must be 12 to 75 years of age * Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1. * Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids). * Weight of ≥ 35 kg. * Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted * Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent. * ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3. * Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol. * Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol. * At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary. Exclusion Criteria: * Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts. * Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period * Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol. * Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion) * Concurrent participation in another clinical study with an IP or a post-authorisation safety study. * History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained. * Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.

Interventions

COMBINATION_PRODUCT

ICS-LABA

COMBINATION_PRODUCT

benralizumab

COMBINATION_PRODUCT

Placebo for Benralizumab

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Conditions

Eosinophilic Asthma

Locations

Research Site

Chandler, Arizona 85224

United States

Research Site

Sun City, Arizona 85351

United States

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Tucson, Arizona 85704

United States

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Bakersfield, California 93301

United States

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Inglewood, California 90301

United States

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Modesto, California 95355

United States

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Newport Beach, California 92663

United States

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Pasadena, California 91101

United States

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Denver, Colorado 80206

United States

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Cape Coral, Florida 33990

United States

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Hialeah, Florida 33015

United States

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Lauderdale Lakes, Florida 33313

United States

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Leesburg, Florida 34748

United States

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Miami, Florida 33122

United States

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Miami, Florida 33155

United States

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Miami, Florida 33175

United States

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Orlando, Florida 32819

United States

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Plantation, Florida 33324

United States

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Tampa, Florida 33607

United States

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Winter Park, Florida 32789

United States

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Ann Arbor, Michigan 48109

United States

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Henderson, Nevada 89052

United States

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Northfield, New Jersey 08225

United States

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Union City, New Jersey 07087

United States

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New Hyde Park, New York 11042

United States

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The Bronx, New York 10459

United States

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Oklahoma City, Oklahoma 73103

United States

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Oklahoma City, Oklahoma 73111

United States

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DuBois, Pennsylvania 15801

United States

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Warwick, Rhode Island 02886

United States

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Greenville, South Carolina 29607

United States

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Houston, Texas 77099

United States

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McKinney, Texas 75069

United States

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San Antonio, Texas 78251

United States

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Dimitrovgrad, 6400

Bulgaria

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Haskovo, 6300

Bulgaria

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Pleven, 5800

Bulgaria

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Plovdiv, 4002

Bulgaria

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Plovdiv, 4023

Bulgaria

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Rousse, 7002

Bulgaria

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Sofia, 1142

Bulgaria

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Sofia, 1431

Bulgaria

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Stara Zagora, 6000

Bulgaria

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Stara Zagora, 6000

Bulgaria

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Edmonton, Alberta T6G 2C8

Canada

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Kamloops, British Columbia V2C 5T1

Canada

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Vancouver, British Columbia V5Z 1M9

Canada

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Ajax, Ontario L1S 2J5

Canada

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Toronto, Ontario M5T 3A9

Canada

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Windsor, Ontario N8X 1T3

Canada

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Québec, Quebec G1G 3Y8

Canada

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Sainte-Foy, Quebec G1V 4G5

Canada

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Beijing, 100020

China

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Beijing, 100044

China

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Beijing, 102218

China

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Changsha, 410004

China

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Chongqing, 400042

China

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Fuzhou, 350001

China

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Fuzhou, 350005

China

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Fuzhou, 350008

China

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Guangzhou, 510120

China

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Guangzhou, 510180

China

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Hangzhou, 31000

China

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Hangzhou, 310014

China

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Hefei, 230061

China

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Huizhou, 516002

China

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Jinan, 250021

China

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Linyi, 276100

China

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Ningbo, 315020

China

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Qinhuangdao,

China

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Shanghai, 200080

China

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Shanghai, 200433

China

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Wenzhou, 325027

China

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Wuhan, 430030

China

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Xuzhou, 221000

China

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Yinchuan, 750004

China

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Zhengzhou, 450000

China

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Bayonne, 64109

France

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Créteil, 94010

France

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La Tronche, 38043

France

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Lyon, 69317

France

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Montpellier, 34295

France

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Pessac, F-33604

France

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Suresnes, 92150

France

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Toulouse, 31059

France

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Villeurbanne, 69100

France

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Berlin, 10367

Germany

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Berlin, 10717

Germany

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Bonn, 53119

Germany

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Cottbus, 03050

Germany

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Delitzsch, 4509

Germany

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Frankfurt am Main, 60389

Germany

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Geesthacht, 21502

Germany

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Hemer, 58675

Germany

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Landsberg, 86899

Germany

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Langen, 63225

Germany

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Lübeck, 23552

Germany

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Mönchengladbach, 41063

Germany

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München, 81377

Germany

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München-Pasing, 81241

Germany

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Neu-Isenburg, 63263

Germany

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Wiesbaden, 65183

Germany

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Witten, 58452

Germany

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Zossen, 15806

Germany

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Hong Kong, 999077

Hong Kong

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Pok Fu Lam, 999077

Hong Kong

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Shatin, 0000

Hong Kong

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Ballinasloe, H53 T971

Ireland

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Cork, T12 DFK4

Ireland

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Dublin, D15 X40D

Ireland

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Moneymore, A92 VW28

Ireland

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Bari, 70124

Italy

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Bergamo, 24127

Italy

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Brescia, 25123

Italy

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Cagliari, 09122

Italy

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Catanzaro, 88100

Italy

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Genoa, 16132

Italy

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Milan, 20122

Italy

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Modena, 41124

Italy

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Montebelluna, 31044

Italy

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Naples, 80131

Italy

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Roma, 00161

Italy

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Roma, 00168

Italy

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Rozzano, 20089

Italy

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Verona, 37124

Italy

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Lørenskog, N-1478

Norway

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Alcorcón, 28922

Spain

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Alzira (Valencia), 46600

Spain

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Badalona, 08916

Spain

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Barakaldo, 48902

Spain

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Barcelona, 08025

Spain

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Barcelona, 08035

Spain

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Burgos, 09006

Spain

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Cáceres, 10003

Spain

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Granada, 18014

Spain

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Jerez de la Frontera, 11407

Spain

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Lugo, 27003

Spain

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Madrid, 28034

Spain

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Madrid, 28041

Spain

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Madrid, 28050

Spain

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Marbella, 29600

Spain

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Marbella, 29603

Spain

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Málaga, 29010

Spain

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Mérida, 06800

Spain

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Palma de Mallorca, 7120

Spain

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Santander, 39008

Spain

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Aarau, 5001

Switzerland

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Basel, 4031

Switzerland

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Lausanne, 1011

Switzerland

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Sankt Gallen, 9007

Switzerland

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Sion, 1951

Switzerland

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Belfast, BT9 7AB

United Kingdom

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Birmingham, B9 5SS

United Kingdom

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Bradford, BD9 6RJ

United Kingdom

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Bristol, BS10 5NB

United Kingdom

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Chorley, PR7 1PP

United Kingdom

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Leeds, LS9 7TF

United Kingdom

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Liverpool, L7 8XP

United Kingdom

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Nottingham, NG7 2UH

United Kingdom

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Portsmouth, PO6 3LY

United Kingdom