A Study to Evaluate 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 tumor necrosis factor alpha-inadequate responders (TNFα-IR) 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:

  • - Subject is male or female at least 18 years of age - Female subjects 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 has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO - 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 except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or 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.

NCT03896581
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 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, Canada, Czechia, Germany, Italy, Japan, Poland, Russian Federation, 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.

Placebo Comparator: Placebo

Subjects randomized to this arm will receive placebo.

Interventions

Drug: - Bimekizumab

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

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.

Pa0011 50017, Phoenix, Arizona

Status

Recruiting

Address

Pa0011 50017

Phoenix, Arizona, 85037

Pa0011 50035, San Diego, California

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Recruiting

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Pa0011 50035

San Diego, California, 92025

Pa0011 50004, Tustin, California

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Suspended

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Pa0011 50004

Tustin, California, 92780

Pa0011 50025, Ocoee, Florida

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Withdrawn

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Pa0011 50025

Ocoee, Florida, 34761

Pa0011 50033, Palm Harbor, Florida

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Suspended

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Pa0011 50033

Palm Harbor, Florida, 34684-3176

Pa0011 50037, Tampa, Florida

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Suspended

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Pa0011 50037

Tampa, Florida, 33613

Pa0011 50039, Atlanta, Georgia

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Suspended

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Pa0011 50039

Atlanta, Georgia, 30342

Pa0011 50024, Boise, Idaho

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Suspended

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Pa0011 50024

Boise, Idaho, 83702

Pa0011 50028, Lexington, Kentucky

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Recruiting

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Pa0011 50028

Lexington, Kentucky, 40504

Pa0011 50023, Baton Rouge, Louisiana

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Suspended

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Pa0011 50023

Baton Rouge, Louisiana, 70836

Pa0011 50015, Hagerstown, Maryland

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Recruiting

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Pa0011 50015

Hagerstown, Maryland, 21742

Pa0011 50026, Wheaton, Maryland

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Suspended

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Pa0011 50026

Wheaton, Maryland, 20902

Pa0011 50047, Boston, Massachusetts

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Suspended

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Pa0011 50047

Boston, Massachusetts, 02115

Pa0011 50019, Lansing, Michigan

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Suspended

Address

Pa0011 50019

Lansing, Michigan, 48910

Pa0011 50001, Saint Louis, Missouri

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Recruiting

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Pa0011 50001

Saint Louis, Missouri, 63141

Pa0011 50016, Saint Louis, Missouri

Status

Recruiting

Address

Pa0011 50016

Saint Louis, Missouri, 63141

Pa0011 50005, Freehold, New Jersey

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Suspended

Address

Pa0011 50005

Freehold, New Jersey, 07728

Pa0011 50029, Albuquerque, New Mexico

Status

Suspended

Address

Pa0011 50029

Albuquerque, New Mexico, 87102

Pa0011 50010, Brooklyn, New York

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Recruiting

Address

Pa0011 50010

Brooklyn, New York, 11201

Pa0011 50011, New York, New York

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Suspended

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Pa0011 50011

New York, New York, 10029

Pa0011 50034, Rochester, New York

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Recruiting

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Pa0011 50034

Rochester, New York, 14642

Pa0011 50125, Charlotte, North Carolina

Status

Recruiting

Address

Pa0011 50125

Charlotte, North Carolina, 28210

Pa0011 50031, Salisbury, North Carolina

Status

Recruiting

Address

Pa0011 50031

Salisbury, North Carolina, 28144

Pa0011 50040, Dayton, Ohio

Status

Recruiting

Address

Pa0011 50040

Dayton, Ohio, 45417

Pa0011 50020, Duncansville, Pennsylvania

Status

Recruiting

Address

Pa0011 50020

Duncansville, Pennsylvania, 16635

Pa0011 50064, Philadelphia, Pennsylvania

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Suspended

Address

Pa0011 50064

Philadelphia, Pennsylvania, 19104

Pa0011 50006, Wyomissing, Pennsylvania

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Suspended

Address

Pa0011 50006

Wyomissing, Pennsylvania, 19610

Pa0011 50008, Johnston, Rhode Island

Status

Recruiting

Address

Pa0011 50008

Johnston, Rhode Island, 02919

Pa0011 50007, Orangeburg, South Carolina

Status

Recruiting

Address

Pa0011 50007

Orangeburg, South Carolina, 29118

Pa0011 50021, Summerville, South Carolina

Status

Recruiting

Address

Pa0011 50021

Summerville, South Carolina, 29486

Pa0011 50012, Memphis, Tennessee

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Suspended

Address

Pa0011 50012

Memphis, Tennessee, 38119

Pa0011 50002, Austin, Texas

Status

Recruiting

Address

Pa0011 50002

Austin, Texas, 78731

Pa0011 50046, Houston, Texas

Status

Withdrawn

Address

Pa0011 50046

Houston, Texas, 77034

Pa0011 50051, Houston, Texas

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Suspended

Address

Pa0011 50051

Houston, Texas, 77034

Pa0011 50048, Houston, Texas

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Suspended

Address

Pa0011 50048

Houston, Texas, 77084

Pa0011 50036, Mesquite, Texas

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Recruiting

Address

Pa0011 50036

Mesquite, Texas, 75150

Pa0011 50009, Waco, Texas

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Suspended

Address

Pa0011 50009

Waco, Texas, 76710

Pa0011 50022, Chesapeake, Virginia

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Suspended

Address

Pa0011 50022

Chesapeake, Virginia, 23320

Pa0011 50032, Bothell, Washington

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Suspended

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Pa0011 50032

Bothell, Washington, 98021

Pa0011 50027, Seattle, Washington

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Suspended

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Pa0011 50027

Seattle, Washington, 98122

Pa0011 50050, Beckley, West Virginia

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Recruiting

Address

Pa0011 50050

Beckley, West Virginia, 25801

International Sites

Pa0011 30005, Camberwell, Australia

Status

Recruiting

Address

Pa0011 30005

Camberwell, ,

Pa0011 30002, Clayton, Australia

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Suspended

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Pa0011 30002

Clayton, ,

Pa0011 30001, Footscray, Australia

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Suspended

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Pa0011 30001

Footscray, ,

Pa0011 30003, Maroochydore, Australia

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Recruiting

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Pa0011 30003

Maroochydore, ,

Pa0011 30007, Victoria Park, Australia

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Recruiting

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Pa0011 30007

Victoria Park, ,

Pa0011 30006, Woodville, Australia

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Recruiting

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Pa0011 30006

Woodville, ,

Pa0011 50041, Quebec City, Canada

Status

Recruiting

Address

Pa0011 50041

Quebec City, ,

Pa0011 50042, Rimouski, Canada

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Recruiting

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Pa0011 50042

Rimouski, ,

Pa0011 50043, Sydney, Canada

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Suspended

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Pa0011 50043

Sydney, ,

Pa0011 50045, Toronto, Canada

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Suspended

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Pa0011 50045

Toronto, ,

Pa0011 50044, Trois-Rivières, Canada

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Recruiting

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Pa0011 50044

Trois-Rivières, ,

Pa0011 40009, Pardubice, Czechia

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Suspended

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Pa0011 40009

Pardubice, ,

Pa0011 40066, Praha 2, Czechia

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Recruiting

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Pa0011 40066

Praha 2, ,

Pa0011 40063, Praha 5, Czechia

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Recruiting

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Pa0011 40063

Praha 5, ,

Pa0011 40012, Zlín, Czechia

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Recruiting

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Pa0011 40012

Zlín, ,

Pa0011 40074, Bad Doberan, Germany

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Suspended

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Pa0011 40074

Bad Doberan, ,

Pa0011 40025, Berlin, Germany

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Suspended

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Pa0011 40025

Berlin, ,

Pa0011 40028, Berlin, Germany

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Suspended

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Pa0011 40028

Berlin, ,

Pa0011 40076, Cottbus, Germany

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Suspended

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Pa0011 40076

Cottbus, ,

Pa0011 40117, Frankfurt, Germany

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Suspended

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Pa0011 40117

Frankfurt, ,

Pa0011 40029, Hamburg, Germany

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Suspended

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Pa0011 40029

Hamburg, ,

Pa0011 40071, Hamburg, Germany

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Suspended

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Pa0011 40071

Hamburg, ,

Pa0011 40027, Herne, Germany

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Suspended

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Pa0011 40027

Herne, ,

Pa0011 40077, Hildesheim, Germany

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Withdrawn

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Pa0011 40077

Hildesheim, ,

Pa0011 40078, Leipzig, Germany

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Suspended

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Pa0011 40078

Leipzig, ,

Pa0011 40348, Magdeburg, Germany

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Suspended

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Pa0011 40348

Magdeburg, ,

Pa0011 40075, Püttlingen, Germany

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Suspended

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Pa0011 40075

Püttlingen, ,

Pa0011 40026, Ratingen, Germany

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Suspended

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Pa0011 40026

Ratingen, ,

Pa0011 40084, Catania, Italy

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Suspended

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Pa0011 40084

Catania, ,

Pa0011 40087, Milano, Italy

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Suspended

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Pa0011 40087

Milano, ,

Pa0011 40086, Reggio Emilia, Italy

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Suspended

Address

Pa0011 40086

Reggio Emilia, ,

Pa0011 20039, Iruma, Japan

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Recruiting

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Pa0011 20039

Iruma, ,

Pa0011 20043, Itabashi-Ku, Japan

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Recruiting

Address

Pa0011 20043

Itabashi-Ku, ,

Pa0011 20036, Kawachi-Nagano, Japan

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Suspended

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Pa0011 20036

Kawachi-Nagano, ,

Pa0011 20045, Kita-Gun, Japan

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Suspended

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Pa0011 20045

Kita-Gun, ,

Pa0011 20049, Kitakyushu, Japan

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Suspended

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Pa0011 20049

Kitakyushu, ,

Pa0011 20044, Minato-Ku, Japan

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Suspended

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Pa0011 20044

Minato-Ku, ,

Pa0011 20033, Nagoya, Japan

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Recruiting

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Pa0011 20033

Nagoya, ,

Pa0011 20038, Nankoku-shi, Japan

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Suspended

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Pa0011 20038

Nankoku-shi, ,

Pa0011 20041, Osaka, Japan

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Recruiting

Address

Pa0011 20041

Osaka, ,

Pa0011 20046, Osaka, Japan

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Suspended

Address

Pa0011 20046

Osaka, ,

Pa0011 20048, Saitama, Japan

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Suspended

Address

Pa0011 20048

Saitama, ,

Pa0011 20031, Sapporo-City, Japan

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Recruiting

Address

Pa0011 20031

Sapporo-City, ,

Pa0011 20042, Sasebo, Japan

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Suspended

Address

Pa0011 20042

Sasebo, ,

Pa0011 20032, Suita, Japan

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Recruiting

Address

Pa0011 20032

Suita, ,

Pa0011 20030, Tokyo, Japan

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Recruiting

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Pa0011 20030

Tokyo, ,

Pa0011 40119, Bydgoszcz, Poland

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Recruiting

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Pa0011 40119

Bydgoszcz, ,

Pa0011 40038, Elbląg, Poland

Status

Recruiting

Address

Pa0011 40038

Elbląg, ,

Pa0011 40037, Lublin, Poland

Status

Recruiting

Address

Pa0011 40037

Lublin, ,

Pa0011 40091, Nowa Sól, Poland

Status

Recruiting

Address

Pa0011 40091

Nowa Sól, ,

Pa0011 40044, Poznań, Poland

Status

Recruiting

Address

Pa0011 40044

Poznań, ,

Pa0011 40090, Poznań, Poland

Status

Recruiting

Address

Pa0011 40090

Poznań, ,

Pa0011 40118, Toruń, Poland

Status

Recruiting

Address

Pa0011 40118

Toruń, ,

Pa0011 40041, Warszawa, Poland

Status

Recruiting

Address

Pa0011 40041

Warszawa, ,

Pa0011 40097, Warszawa, Poland

Status

Recruiting

Address

Pa0011 40097

Warszawa, ,

Pa0011 40098, Warszawa, Poland

Status

Recruiting

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Pa0011 40098

Warszawa, ,

Pa0011 40039, Wrocław, Poland

Status

Recruiting

Address

Pa0011 40039

Wrocław, ,

Pa0011 40043, Wrocław, Poland

Status

Recruiting

Address

Pa0011 40043

Wrocław, ,

Pa0011 20002, Moscow, Russian Federation

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Suspended

Address

Pa0011 20002

Moscow, ,

Pa0011 20005, Moscow, Russian Federation

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Suspended

Address

Pa0011 20005

Moscow, ,

Pa0011 20010, Moscow, Russian Federation

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Suspended

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Pa0011 20010

Moscow, ,

Pa0011 20013, Petrozavodsk, Russian Federation

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Suspended

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Pa0011 20013

Petrozavodsk, ,

Pa0011 20001, Saint Petersburg, Russian Federation

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Suspended

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Pa0011 20001

Saint Petersburg, ,

Pa0011 20004, Saint Petersburg, Russian Federation

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Suspended

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Pa0011 20004

Saint Petersburg, ,

Pa0011 20009, Saint Petersburg, Russian Federation

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Suspended

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Pa0011 20009

Saint Petersburg, ,

Pa0011 20007, Saratov, Russian Federation

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Suspended

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Pa0011 20007

Saratov, ,

Pa0011 20014, Ulyanovsk, Russian Federation

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Suspended

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Pa0011 20014

Ulyanovsk, ,

Pa0011 20006, Vladimir, Russian Federation

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Suspended

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Pa0011 20006

Vladimir, ,

Pa0011 20008, Yaroslavl, Russian Federation

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Suspended

Address

Pa0011 20008

Yaroslavl, ,

Pa0011 20015, Yaroslavl, Russian Federation

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Suspended

Address

Pa0011 20015

Yaroslavl, ,

Pa0011 40115, Barnsley, United Kingdom

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Suspended

Address

Pa0011 40115

Barnsley, ,

Pa0011 40111, Bradford, United Kingdom

Status

Suspended

Address

Pa0011 40111

Bradford, ,

Pa0011 40112, Cornwell, United Kingdom

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Suspended

Address

Pa0011 40112

Cornwell, ,

Pa0011 40109, Oxford, United Kingdom

Status

Suspended

Address

Pa0011 40109

Oxford, ,

Pa0011 40116, Stamford, United Kingdom

Status

Suspended

Address

Pa0011 40116

Stamford, ,

Pa0011 40107, Wolverhampton, United Kingdom

Status

Suspended

Address

Pa0011 40107

Wolverhampton, ,

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