A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Purpose

This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male or female at least 18 years of age - Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit - Subject must have Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5 point scale - Subject must be a candidate for systemic PSO therapy and/or phototherapy - Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label - Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

- Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection - Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study - Presence of active suicidal ideation or severe depression - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03536884
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma S.P.R.L.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation +1 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ps0015 975, Santa Ana, California

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Recruiting

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Ps0015 975

Santa Ana, California, 92701

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+1844599

Ps0015 939, Danbury, Connecticut

Status

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Address

Ps0015 939

Danbury, Connecticut, 06810

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+1844599

Ps0015 974, Coral Gables, Florida

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Ps0015 974

Coral Gables, Florida, 33134-3324

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+1844599

Ps0015 903, Ocala, Florida

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Ps0015 903

Ocala, Florida, 34470

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+1844599

Ps0015 921, Ormond Beach, Florida

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Ps0015 921

Ormond Beach, Florida, 32174

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+1844599

Ps0015 977, Pembroke Pines, Florida

Status

Recruiting

Address

Ps0015 977

Pembroke Pines, Florida, 33028

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+1844599

Ps0015 977, Tampa, Florida

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Recruiting

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Ps0015 977

Tampa, Florida, 33614

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+1844599

Ps0015 936, Tampa, Florida

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Ps0015 936

Tampa, Florida, 33624

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+1844599

Ps0015 970, West Palm Beach, Florida

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Ps0015 970

West Palm Beach, Florida, 33409

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+1844599

Ps0015 966, Sandy Springs, Georgia

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Ps0015 966

Sandy Springs, Georgia, 30328

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+1844599

Ps0015 954, Skokie, Illinois

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Ps0015 954

Skokie, Illinois, 60077

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+1844599

Ps0015 972, West Dundee, Illinois

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Ps0015 972

West Dundee, Illinois, 60118

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+1844599

Ps0015 900, West Des Moines, Iowa

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Ps0015 900

West Des Moines, Iowa, 50265

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+1844599

Ps0015 944, New Orleans, Louisiana

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Ps0015 944

New Orleans, Louisiana, 70124

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+1844599

Ps0015 915, Saint Louis, Missouri

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Recruiting

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Ps0015 915

Saint Louis, Missouri, 63117

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+1844599

Ps0015 953, Saint Louis, Missouri

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Recruiting

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Ps0015 953

Saint Louis, Missouri, 63141

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+1844599

Ps0015 901, Portsmouth, New Hampshire

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Ps0015 901

Portsmouth, New Hampshire, 03801

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+1844599

Ps0015 965, Forest Hills, New York

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Ps0015 965

Forest Hills, New York, 11375

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+1844599

Ps0015 969, High Point, North Carolina

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Ps0015 969

High Point, North Carolina, 27262

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+1844599

Ps0015 971, Wilmington, North Carolina

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Ps0015 971

Wilmington, North Carolina, 28405

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+1844599

Ps0015 980, Bexley, Ohio

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Recruiting

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Ps0015 980

Bexley, Ohio, 43209

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+1844599

Ps0015 920, Portland, Oregon

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Ps0015 920

Portland, Oregon, 97210

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+1844599

Ps0015 929, Portland, Oregon

Status

Recruiting

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Ps0015 929

Portland, Oregon, 97223

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+1844599

Ps0015 979, Dallas, Texas

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Recruiting

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Ps0015 979

Dallas, Texas, 75246

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+1844599

Ps0015 924, Houston, Texas

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Recruiting

Address

Ps0015 924

Houston, Texas, 77004

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+1844599

Ps0015 778, Pflugerville, Texas

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Ps0015 778

Pflugerville, Texas, 78660

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International Sites

Ps0015 455, Alicante, Spain

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Ps0015 455

Alicante, ,

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+1844599

Ps0015 450, Barcelona, Spain

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Ps0015 450

Barcelona, ,

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Ps0015 456, Madrid, Spain

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Ps0015 456

Madrid, ,

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+1844599

Ps0015 763, Gaziantep, Turkey

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Ps0015 763

Gaziantep, ,

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+1844599

Ps0015 760, Kayseri, Turkey

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Ps0015 760

Kayseri, ,

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+1844599

Ps0015 677, Toronto, Canada

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Ps0015 677

Toronto, ,

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Ps0015 657, Waterloo, Canada

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Ps0015 657

Waterloo, ,

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Ps0015 679, Winnipeg, Canada

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Ps0015 679

Winnipeg, ,

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+1844599

Ps0015 156, Bordeaux, France

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Ps0015 156

Bordeaux, ,

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+1844599

Ps0015 157, Rennes, France

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Ps0015 157

Rennes, ,

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Ps0015 153, Toulouse, France

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Ps0015 153

Toulouse, ,

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Ps0015 223, Augsburg, Germany

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Ps0015 223

Augsburg, ,

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Ps0015 237, Berlin, Germany

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Ps0015 237

Berlin, ,

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Ps0015 211, Hamburg, Germany

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Ps0015 211

Hamburg, ,

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Ps0015 213, Mahlow, Germany

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Ps0015 213

Mahlow, ,

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Ps0015 238, Mainz, Germany

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Ps0015 238

Mainz, ,

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Ps0015 234, Muenchen, Germany

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Ps0015 234

Muenchen, ,

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Ps0015 219, Münster, Germany

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Ps0015 219

Münster, ,

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+1844599

Ps0015 236, Neu-Ulm, Germany

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Ps0015 236

Neu-Ulm, ,

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Ps0015 222, Tuebingen, Germany

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Ps0015 222

Tuebingen, ,

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Ps0015 204, Witten, Germany

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Ps0015 204

Witten, ,

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Ps0015 377, Ostrowiec Świętokrzyski, Poland

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Ps0015 377

Ostrowiec Świętokrzyski, ,

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Ps0015 375, Wrocław, Poland

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Ps0015 375

Wrocław, ,

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+1844599

Ps0015 372, Łódź, Poland

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Ps0015 372

Łódź, ,

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Ps0015 376, Kraków, Poland

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Ps0015 376

Kraków, ,

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Ps0015 678, Richmond Hill, Canada

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Ps0015 678

Richmond Hill, ,

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Ps0015 379, Kraków, Poland

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Ps0015 379

Kraków, ,

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+1844599

Ps0015 003, Carlton, Australia

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Ps0015 003

Carlton, ,

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Ps0015 006, Carlton, Australia

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Ps0015 006

Carlton, ,

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Ps0015 007, Hectorville, Australia

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Ps0015 007

Hectorville, ,

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+1844599

Ps0015 009, Woolloongabba, Australia

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Ps0015 009

Woolloongabba, ,

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Ps0015 054, Brussels, Belgium

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Ps0015 054

Brussels, ,

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Ps0015 050, Bruxelles, Belgium

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Ps0015 050

Bruxelles, ,

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Ps0015 052, Liège, Belgium

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Ps0015 052

Liège, ,

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+1844599

Ps0015 671, Hamilton, Canada

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Ps0015 671

Hamilton, ,

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Ps0015 663, Mississauga, Canada

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Ps0015 663

Mississauga, ,

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Ps0015 661, Peterborough, Canada

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Ps0015 661

Peterborough, ,

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Ps0015 265, Amsterdam, Netherlands

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Ps0015 265

Amsterdam, ,

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+1844599

Ps0015 263, Breda, Netherlands

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Ps0015 263

Breda, ,

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Ps0015 355, Białystok, Poland

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Ps0015 355

Białystok, ,

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+1844599

Ps0015 361, Białystok, Poland

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Ps0015 361

Białystok, ,

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+1844599

Ps0015 369, Białystok, Poland

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Ps0015 369

Białystok, ,

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+1844599

Ps0015 352, Gdańsk, Poland

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Ps0015 352

Gdańsk, ,

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+1844599

Ps0015 366, Katowice, Poland

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Ps0015 366

Katowice, ,

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Ps0015 378, Katowice, Poland

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Ps0015 378

Katowice, ,

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Ps0015 559, Newcastle Upon Tyne, United Kingdom

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Ps0015 559

Newcastle Upon Tyne, ,

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+1844599

Ps0015 555, Salford, United Kingdom

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Recruiting

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Ps0015 555

Salford, ,

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+1844599

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