A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Study Purpose

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).

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:

  • - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
  • - Subject is male or female at least 18 years of age.
  • - Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception.
  • - Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66.
  • - Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies.
  • - Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO) - Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator.
  • - Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry.

Exclusion Criteria:

  • - Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study.
  • - Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO) - Subject has an active infection or a history of recent serious infections.
  • - 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 a diagnosis of inflammatory conditions other than PSO or PsA.
Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline.
  • - Subject had acute anterior uveitis within 6 weeks of Baseline.
  • - 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.
  • - Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO) - Presence of active suicidal ideation, or moderately severe major depression or severe major depression.
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

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.

NCT03895203
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 SRL
Principal Investigator

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

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

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

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Russian Federation, Spain, United Kingdom, United States
Conditions

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

Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: Bimekzumab dosage regimen

Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.

Active Comparator: Adalimumab dosage regimen

Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.

Placebo Comparator: Placebo

Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.

Interventions

Drug: - Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Drug: - Adalimumab

Adalimumab will be administered according to the labeling recommendations.

Other: - Placebo

Subjects will receive placebo at pre-specified time-points.

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.

Pa0010 50125, Charlotte, North Carolina

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Recruiting

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Pa0010 50125

Charlotte, North Carolina, 28210

Pa0010 50013, Wilmington, North Carolina

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Suspended

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Pa0010 50013

Wilmington, North Carolina, 28401

Pa0010 50040, Dayton, Ohio

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Recruiting

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Pa0010 50040

Dayton, Ohio, 45417

Pa0010 50020, Duncansville, Pennsylvania

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Recruiting

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Pa0010 50020

Duncansville, Pennsylvania, 16635

Pa0010 50006, Wyomissing, Pennsylvania

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Suspended

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Pa0010 50006

Wyomissing, Pennsylvania, 19610

Pa0010 50008, Johnston, Rhode Island

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Recruiting

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Pa0010 50008

Johnston, Rhode Island, 02919

Pa0010 50007, Orangeburg, South Carolina

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Recruiting

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Pa0010 50007

Orangeburg, South Carolina, 29118

Pa0010 50021, Summerville, South Carolina

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Suspended

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Pa0010 50021

Summerville, South Carolina, 29486

Pa0010 50001, Jackson, Tennessee

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Recruiting

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Pa0010 50001

Jackson, Tennessee, 38305

Pa0010 50012, Memphis, Tennessee

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Suspended

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Pa0010 50012

Memphis, Tennessee, 38119

Pa0010 50002, Austin, Texas

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Recruiting

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Pa0010 50002

Austin, Texas, 78731

Pa0010 50046, Baytown, Texas

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Withdrawn

Address

Pa0010 50046

Baytown, Texas, 77521

Pa0010 50048, Baytown, Texas

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Withdrawn

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Pa0010 50048

Baytown, Texas, 77521

Pa0010 50049, Corpus Christi, Texas

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Suspended

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Pa0010 50049

Corpus Christi, Texas, 78404

Pa0010 50051, Houston, Texas

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Completed

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Pa0010 50051

Houston, Texas, 77034

Pa0010 50036, Mesquite, Texas

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Recruiting

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Pa0010 50036

Mesquite, Texas, 75150

Pa0010 50009, Waco, Texas

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Suspended

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Pa0010 50009

Waco, Texas, 76710

Pa0010 50022, Chesapeake, Virginia

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Withdrawn

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Pa0010 50022

Chesapeake, Virginia, 23320

Pa0010 50027, Seattle, Washington

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Suspended

Address

Pa0010 50027

Seattle, Washington, 98122

Pa0010 50050, Beckley, West Virginia

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Recruiting

Address

Pa0010 50050

Beckley, West Virginia, 25801

Pa0010 50017, Phoenix, Arizona

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Recruiting

Address

Pa0010 50017

Phoenix, Arizona, 85037

Pa0010 50035, San Diego, California

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Recruiting

Address

Pa0010 50035

San Diego, California, 92025

Pa0010 50004, Tustin, California

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Suspended

Address

Pa0010 50004

Tustin, California, 92780

Pa0010 50025, Ocoee, Florida

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Withdrawn

Address

Pa0010 50025

Ocoee, Florida, 34761

Pa0010 50033, Palm Harbor, Florida

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Suspended

Address

Pa0010 50033

Palm Harbor, Florida, 34684

Pa0010 50037, Tampa, Florida

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Suspended

Address

Pa0010 50037

Tampa, Florida, 33613

Pa0010 50039, Atlanta, Georgia

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Suspended

Address

Pa0010 50039

Atlanta, Georgia, 30342

Pa0010 50028, Lexington, Kentucky

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Recruiting

Address

Pa0010 50028

Lexington, Kentucky, 40504

Pa0010 50023, Baton Rouge, Louisiana

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Suspended

Address

Pa0010 50023

Baton Rouge, Louisiana, 70836

Pa0010 50015, Hagerstown, Maryland

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Recruiting

Address

Pa0010 50015

Hagerstown, Maryland, 21742

Pa0010 50016, Saint Louis, Missouri

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Recruiting

Address

Pa0010 50016

Saint Louis, Missouri, 63141

Pa0010 50029, Albuquerque, New Mexico

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Suspended

Address

Pa0010 50029

Albuquerque, New Mexico, 87102

Pa0010 50010, Brooklyn, New York

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Recruiting

Address

Pa0010 50010

Brooklyn, New York, 11201

International Sites

Pa0010 30005, Camberwell, Australia

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Recruiting

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Pa0010 30005

Camberwell, ,

Pa0010 30002, Clayton, Australia

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Recruiting

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Pa0010 30002

Clayton, ,

Pa0010 30001, Footscray, Australia

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Suspended

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Pa0010 30001

Footscray, ,

Pa0010 30008, Hobart, Australia

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Suspended

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Pa0010 30008

Hobart, ,

Pa0010 30004, Liverpool, Australia

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Recruiting

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Pa0010 30004

Liverpool, ,

Pa0010 30003, Maroochydore, Australia

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Recruiting

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Pa0010 30003

Maroochydore, ,

Pa0010 30007, Victoria Park, Australia

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Recruiting

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Pa0010 30007

Victoria Park, ,

Pa0010 30006, Woodville, Australia

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Recruiting

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Pa0010 30006

Woodville, ,

Pa0010 40058, Brussels, Belgium

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Recruiting

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Pa0010 40058

Brussels, ,

Pa0010 40003, Genk, Belgium

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Recruiting

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Pa0010 40003

Genk, ,

Pa0010 40002, Leuven, Belgium

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Suspended

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Pa0010 40002

Leuven, ,

Pa0010 40060, Liège, Belgium

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Recruiting

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Pa0010 40060

Liège, ,

Pa0010 40059, Mons, Belgium

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Recruiting

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Pa0010 40059

Mons, ,

Pa0010 50041, Québec City, Canada

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Recruiting

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Pa0010 50041

Québec City, ,

Pa0010 50042, Rimouski, Canada

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Recruiting

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Pa0010 50042

Rimouski, ,

Pa0010 50043, Sidney, Canada

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Suspended

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Pa0010 50043

Sidney, ,

Pa0010 50045, Toronto, Canada

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Suspended

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Pa0010 50045

Toronto, ,

Pa0010 50044, Trois-Rivières, Canada

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Recruiting

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Pa0010 50044

Trois-Rivières, ,

Pa0010 40061, Brno, Czechia

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Completed

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Pa0010 40061

Brno, ,

Pa0010 40065, Brno, Czechia

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Recruiting

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Pa0010 40065

Brno, ,

Pa0010 40064, Olomouc, Czechia

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Suspended

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Pa0010 40064

Olomouc, ,

Pa0010 40062, Ostrava, Czechia

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Suspended

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Pa0010 40062

Ostrava, ,

Pa0010 40009, Pardubice, Czechia

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Completed

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Pa0010 40009

Pardubice, ,

Pa0010 40013, Praha 11, Czechia

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Recruiting

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Pa0010 40013

Praha 11, ,

Pa0010 40066, Praha 2, Czechia

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Completed

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Pa0010 40066

Praha 2, ,

Pa0010 40014, Praha 4, Czechia

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Completed

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Pa0010 40014

Praha 4, ,

Pa0010 40063, Praha 5, Czechia

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Completed

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Pa0010 40063

Praha 5, ,

Pa0010 40015, Praha, Czechia

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Recruiting

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Pa0010 40015

Praha, ,

Pa0010 40010, Uherské Hradiště, Czechia

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Completed

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Pa0010 40010

Uherské Hradiště, ,

Pa0010 40012, Zlín, Czechia

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Recruiting

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Pa0010 40012

Zlín, ,

Pa0010 40070, Clermont-Ferrand, France

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Suspended

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Pa0010 40070

Clermont-Ferrand, ,

Pa0010 40067, Lyon, France

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Recruiting

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Pa0010 40067

Lyon, ,

Pa0010 40019, Paris, France

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Recruiting

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Pa0010 40019

Paris, ,

Pa0010 40069, Paris, France

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Suspended

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Pa0010 40069

Paris, ,

Pa0010 40068, Tours, France

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Recruiting

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Pa0010 40068

Tours, ,

Pa0010 40074, Bad Doberan, Germany

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Recruiting

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Pa0010 40074

Bad Doberan, ,

Pa0010 40025, Berlin, Germany

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Suspended

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Pa0010 40025

Berlin, ,

Pa0010 40028, Berlin, Germany

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Recruiting

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Pa0010 40028

Berlin, ,

Pa0010 40076, Cottbus, Germany

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Suspended

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Pa0010 40076

Cottbus, ,

Pa0010 40023, Erlangen, Germany

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Recruiting

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Pa0010 40023

Erlangen, ,

Pa0010 40117, Frankfurt, Germany

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Recruiting

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Pa0010 40117

Frankfurt, ,

Pa0010 40029, Hamburg, Germany

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Recruiting

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Pa0010 40029

Hamburg, ,

Pa0010 40071, Hamburg, Germany

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Suspended

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Pa0010 40071

Hamburg, ,

Pa0010 40027, Herne, Germany

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Suspended

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Pa0010 40027

Herne, ,

Pa0010 40077, Hildesheim, Germany

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Withdrawn

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Pa0010 40077

Hildesheim, ,

Pa0010 40078, Leipzig, Germany

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Suspended

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Pa0010 40078

Leipzig, ,

Pa0010 40348, Magdeburg, Germany

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Recruiting

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Pa0010 40348

Magdeburg, ,

Pa0010 40026, Ratingen, Germany

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Suspended

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Pa0010 40026

Ratingen, ,

Pa0010 40081, Budapest, Hungary

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Suspended

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Pa0010 40081

Budapest, ,

Pa0010 40083, Budapest, Hungary

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Suspended

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Pa0010 40083

Budapest, ,

Pa0010 40032, Debrecen, Hungary

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Suspended

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Pa0010 40032

Debrecen, ,

Pa0010 40030, Eger, Hungary

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Pa0010 40030

Eger, ,

Pa0010 40082, Kistarcsa, Hungary

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Suspended

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Pa0010 40082

Kistarcsa, ,

Pa0010 40079, Szentes, Hungary

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Suspended

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Pa0010 40079

Szentes, ,

Pa0010 40080, Szombathely, Hungary

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Suspended

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Pa0010 40080

Szombathely, ,

Pa0010 40033, Székesfehérvár, Hungary

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Recruiting

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Pa0010 40033

Székesfehérvár, ,

Pa0010 40084, Catania, Italy

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Suspended

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Pa0010 40084

Catania, ,

Pa0010 40087, Milano, Italy

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Suspended

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Pa0010 40087

Milano, ,

Pa0010 40085, Pisa, Italy

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Recruiting

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Pa0010 40085

Pisa, ,

Pa0010 40086, Reggio Emilia, Italy

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Recruiting

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Pa0010 40086

Reggio Emilia, ,

Pa0010 20035, Bunkyō-Ku, Japan

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Recruiting

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Pa0010 20035

Bunkyō-Ku, ,

Pa0010 20043, Itabashi, Japan

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Completed

Address

Pa0010 20043

Itabashi, ,

Pa0010 20036, Kawachi-Nagano-shi, Japan

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Suspended

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Pa0010 20036

Kawachi-Nagano-shi, ,

Pa0010 20049, Kitakyushu, Japan

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Suspended

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Pa0010 20049

Kitakyushu, ,

Pa0010 20045, Kita, Japan

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Suspended

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Pa0010 20045

Kita, ,

Pa0010 20044, Minato-Ku, Japan

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Suspended

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Pa0010 20044

Minato-Ku, ,

Pa0010 20033, Nagoya, Japan

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Recruiting

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Pa0010 20033

Nagoya, ,

Pa0010 20038, Nankoku, Japan

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Suspended

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Pa0010 20038

Nankoku, ,

Pa0010 20041, Osaka, Japan

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Recruiting

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Pa0010 20041

Osaka, ,

Pa0010 20046, Osaka, Japan

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Suspended

Address

Pa0010 20046

Osaka, ,

Pa0010 20048, Saitama, Japan

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Suspended

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Pa0010 20048

Saitama, ,

Pa0010 20031, Sapporo-City, Japan

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Completed

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Pa0010 20031

Sapporo-City, ,

Pa0010 20042, Sasebo, Japan

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Suspended

Address

Pa0010 20042

Sasebo, ,

Pa0010 20032, Suita, Japan

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Active, not recruiting

Address

Pa0010 20032

Suita, ,

Pa0010 20030, Tokyo, Japan

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Recruiting

Address

Pa0010 20030

Tokyo, ,

Pa0010 40093, Białystok, Poland

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Suspended

Address

Pa0010 40093

Białystok, ,

Pa0010 40119, Bydgoszcz, Poland

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Suspended

Address

Pa0010 40119

Bydgoszcz, ,

Pa0010 40038, Elbląg, Poland

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Suspended

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Pa0010 40038

Elbląg, ,

Pa0010 40088, Elbląg, Poland

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Suspended

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Pa0010 40088

Elbląg, ,

Pa0010 40096, Gdynia, Poland

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Suspended

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Pa0010 40096

Gdynia, ,

Pa0010 40042, Kraków, Poland

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Suspended

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Pa0010 40042

Kraków, ,

Pa0010 40092, Kraków, Poland

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Suspended

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Pa0010 40092

Kraków, ,

Pa0010 40037, Lublin, Poland

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Suspended

Address

Pa0010 40037

Lublin, ,

Pa0010 40091, Nowa Sól, Poland

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Suspended

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Pa0010 40091

Nowa Sól, ,

Pa0010 40044, Poznań, Poland

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Suspended

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Pa0010 40044

Poznań, ,

Pa0010 40090, Poznań, Poland

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Suspended

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Pa0010 40090

Poznań, ,

Pa0010 40118, Toruń, Poland

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Suspended

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Pa0010 40118

Toruń, ,

Pa0010 40041, Warszawa, Poland

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Suspended

Address

Pa0010 40041

Warszawa, ,

Pa0010 40094, Warszawa, Poland

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Suspended

Address

Pa0010 40094

Warszawa, ,

Pa0010 40097, Warszawa, Poland

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Suspended

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Pa0010 40097

Warszawa, ,

Pa0010 40098, Warszawa, Poland

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Suspended

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Pa0010 40098

Warszawa, ,

Pa0010 40039, Wrocław, Poland

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Suspended

Address

Pa0010 40039

Wrocław, ,

Pa0010 40043, Wrocław, Poland

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Suspended

Address

Pa0010 40043

Wrocław, ,

Pa0010 40095, Wrocław, Poland

Status

Recruiting

Address

Pa0010 40095

Wrocław, ,

Pa0010 20002, Moscow, Russian Federation

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Suspended

Address

Pa0010 20002

Moscow, ,

Pa0010 20005, Moscow, Russian Federation

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Suspended

Address

Pa0010 20005

Moscow, ,

Pa0010 20010, Moscow, Russian Federation

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Suspended

Address

Pa0010 20010

Moscow, ,

Pa0010 20017, Moscow, Russian Federation

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Suspended

Address

Pa0010 20017

Moscow, ,

Pa0010 20013, Petrozavodsk, Russian Federation

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Suspended

Address

Pa0010 20013

Petrozavodsk, ,

Pa0010 20012, Ryazan', Russian Federation

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Suspended

Address

Pa0010 20012

Ryazan', ,

Pa0010 20016, Ryazan', Russian Federation

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Suspended

Address

Pa0010 20016

Ryazan', ,

Pa0010 20001, Saint Petersburg, Russian Federation

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Suspended

Address

Pa0010 20001

Saint Petersburg, ,

Pa0010 20003, Saint Petersburg, Russian Federation

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Suspended

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Pa0010 20003

Saint Petersburg, ,

Pa0010 20004, Saint Petersburg, Russian Federation

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Suspended

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Pa0010 20004

Saint Petersburg, ,

Pa0010 20009, Saint Petersburg, Russian Federation

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Suspended

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Pa0010 20009

Saint Petersburg, ,

Pa0010 20083, Saint Petersburg, Russian Federation

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Suspended

Address

Pa0010 20083

Saint Petersburg, ,

Pa0010 20007, Saratov, Russian Federation

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Suspended

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Pa0010 20007

Saratov, ,

Pa0010 20014, Ulyanovsk, Russian Federation

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Suspended

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Pa0010 20014

Ulyanovsk, ,

Pa0010 20006, Vladimir, Russian Federation

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Suspended

Address

Pa0010 20006

Vladimir, ,

Pa0010 20008, Yaroslavl, Russian Federation

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Suspended

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Pa0010 20008

Yaroslavl, ,

Pa0010 20015, Yaroslavl, Russian Federation

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Suspended

Address

Pa0010 20015

Yaroslavl, ,

Pa0010 40045, Coruña, Spain

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Suspended

Address

Pa0010 40045

Coruña, ,

Pa0010 40105, Córdoba, Spain

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Suspended

Address

Pa0010 40105

Córdoba, ,

Pa0010 40100, Madrid, Spain

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Suspended

Address

Pa0010 40100

Madrid, ,

Pa0010 40102, Málaga, Spain

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Recruiting

Address

Pa0010 40102

Málaga, ,

Pa0010 40101, Sabadell, Spain

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Suspended

Address

Pa0010 40101

Sabadell, ,

Pa0010 40104, Santiago De Compostela, Spain

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Suspended

Address

Pa0010 40104

Santiago De Compostela, ,

Pa0010 40049, Sevilla, Spain

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Suspended

Address

Pa0010 40049

Sevilla, ,

Pa0010 40103, Sevilla, Spain

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Recruiting

Address

Pa0010 40103

Sevilla, ,

Pa0010 40106, Sevilla, Spain

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Recruiting

Address

Pa0010 40106

Sevilla, ,

Pa0010 40099, Vigo, Spain

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Suspended

Address

Pa0010 40099

Vigo, ,

Pa0010 40115, Barnsley, United Kingdom

Status

Suspended

Address

Pa0010 40115

Barnsley, ,

Pa0010 40112, Cornwell, United Kingdom

Status

Suspended

Address

Pa0010 40112

Cornwell, ,

Pa0010 40111, Leeds, United Kingdom

Status

Suspended

Address

Pa0010 40111

Leeds, ,

Pa0010 40109, Oxford, United Kingdom

Status

Suspended

Address

Pa0010 40109

Oxford, ,

Pa0010 40110, Wirral, United Kingdom

Status

Suspended

Address

Pa0010 40110

Wirral, ,

Pa0010 40107, Wolverhampton, United Kingdom

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Suspended

Address

Pa0010 40107

Wolverhampton, ,