IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Last updated: January 16, 2026
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Peripheral Neuropathy

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT07032662
IMVT-1402-2401
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have met clinical diagnostic criteria for typical CIDP or one of the following CIDPvariants: multifocal CIDP or motor CIDP per the 2021 European Academy ofNeurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment ofCIDP.

  • Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNSguideline on diagnosis and treatment of CIDP.

  • Are currently on, and have been receiving chronic, stable doses of systemiccorticosteroids (i.e., daily or every other day oral or pulse regimen), orimmunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3months for the treatment of CIDP at the time of the Screening Visit.

Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  • Have current or prior history of IgM paraproteinemia with or withoutanti-myelin-associated-glycoprotein antibodies.

  • Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy perthe EAN/PNS guideline on diagnosis and treatment of CIDP.

  • Have polyneuropathy of causes other than CIDP including but not limited to:

  • Multifocal motor neuropathy

  • Hereditary demyelinating neuropathy

  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skinchange syndromes (i.e., POEMS)

  • Lumbosacral radiculoplexus neuropathy

  • Systemic illnesses including vitamin deficiency syndromes and paraneoplasticneuropathies

  • Drug- or toxin-induced

  • Have diabetes mellitus (DM) and meets any of the following criteria:

  • Does not have both typical CIDP and strong evidence of demyelination on nerveconduction study.

  • In the opinion of the Investigator, there is evidence of poorly controlled DMpreceding the diagnosis of CIDP.

  • In the opinion of the Investigator, there is evidence of poorly controlled DMat screening.

  • Have a history of myelopathy or evidence of central demyelination. Additionalexclusion criteria are defined in the protocol.

Study Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 18, 2025
Estimated Completion Date:
May 31, 2030

Study Description

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.

Connect with a study center

  • Site Number - 5002

    Buenos Aires,
    Argentina

    Site Not Available

  • Site Number - 5002

    Buenos Aires 3435910,
    Argentina

    Site Not Available

  • Site Number - 5001

    Córdoba,
    Argentina

    Site Not Available

  • Site Number - 5003

    Córdoba,
    Argentina

    Site Not Available

  • Site Number - 5001

    Córdoba 3860259,
    Argentina

    Site Not Available

  • Site Number - 5003

    Córdoba 3860259,
    Argentina

    Site Not Available

  • Site Number - 5000

    Rosario,
    Argentina

    Site Not Available

  • Site Number - 5000

    Rosario 3838583,
    Argentina

    Site Not Available

  • Site Number - 5102

    Brisbane,
    Australia

    Site Not Available

  • Site Number - 5102

    Brisbane 2174003,
    Australia

    Site Not Available

  • Site Number - 5100

    Macquarie Park,
    Australia

    Site Not Available

  • Site Number - 5100

    Macquarie Park 8347858,
    Australia

    Site Not Available

  • Site Number - 5103

    Parkville,
    Australia

    Site Not Available

  • Site Number - 5103

    Parkville 2153770,
    Australia

    Site Not Available

  • Site Number - 5200

    Vienna 2761369,
    Austria

    Site Not Available

  • Site Number - 5200

    Wien,
    Austria

    Site Not Available

  • Site Number - 5300

    Leuven,
    Belgium

    Site Not Available

  • Site Number - 5300

    Leuven 2792482,
    Belgium

    Active - Recruiting

  • Site Number - 5400

    Banja Luka,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5400

    Banja Luka 3204541,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5402

    Bihac,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5402

    Bihać 3204222,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5401

    Mostar,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5401

    Mostar 3194828,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5403

    Sarajevo,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5403

    Sarajevo 3191281,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5506

    Brasília,
    Brazil

    Site Not Available

  • Site Number - 5506

    Brasília 3469058,
    Brazil

    Site Not Available

  • Site Number - 5503

    Campinas,
    Brazil

    Site Not Available

  • Site Number - 5503

    Campinas 3467865,
    Brazil

    Site Not Available

  • Site Number - 5500

    Curitiba,
    Brazil

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  • Site Number - 5500

    Curitiba 3464975,
    Brazil

    Site Not Available

  • Site Number - 5502

    Joinville,
    Brazil

    Site Not Available

  • Site Number - 5502

    Joinville 3459712,
    Brazil

    Site Not Available

  • Site Number - 5501

    Porto Alegre,
    Brazil

    Site Not Available

  • Site Number - 5504

    Porto Alegre,
    Brazil

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  • Site Number - 5501

    Porto Alegre 3452925,
    Brazil

    Site Not Available

  • Site Number - 5504

    Porto Alegre 3452925,
    Brazil

    Site Not Available

  • Site Number - 5505

    Vila Clementino,
    Brazil

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  • Site Number - 5505

    Vila Clementino 10227139,
    Brazil

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  • Site Number - 5601

    Pleven,
    Bulgaria

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  • Site Number - 5601

    Pleven 728203,
    Bulgaria

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    Sofia,
    Bulgaria

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  • Site Number - 5602

    Sofia,
    Bulgaria

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  • Site Number - 5603

    Sofia,
    Bulgaria

    Site Not Available

  • Site Number - 5604

    Sofia,
    Bulgaria

    Site Not Available

  • Site Number - 5600

    Sofia 727011,
    Bulgaria

    Active - Recruiting

  • Site Number - 5602

    Sofia 727011,
    Bulgaria

    Active - Recruiting

  • Site Number - 5603

    Sofia 727011,
    Bulgaria

    Active - Recruiting

  • Site Number - 5604

    Sofia 727011,
    Bulgaria

    Site Not Available

  • Site Number - 5800

    Bogotá,
    Colombia

    Site Not Available

  • Site Number - 5800

    Bogotá 3688689,
    Colombia

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  • Site Number - 3600

    Copenhagen,
    Denmark

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  • Site Number - 3600

    Copenhagen 2618425,
    Denmark

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  • Site Number - 3601

    Odense,
    Denmark

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  • Site Number - 3601

    Odense 2615876,
    Denmark

    Active - Recruiting

  • Site Number - 7251

    Tallin,
    Estonia

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    Tallinn 588409,
    Estonia

    Active - Recruiting

  • Site Number - 3800

    Turku,
    Finland

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  • Site Number - 3800

    Turku 633679,
    Finland

    Active - Recruiting

  • Site Number - 6505

    Berlin,
    Germany

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  • Site Number - 6505

    Berlin 2950159,
    Germany

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  • Site Number - 6501

    Bochum,
    Germany

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  • Site Number - 6501

    Bochum 2947416,
    Germany

    Active - Recruiting

  • Site Number - 6504

    Essen,
    Germany

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  • Site Number - 6504

    Essen 2928810,
    Germany

    Site Not Available

  • Site Number - 6500

    Tübingen,
    Germany

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  • Site Number - 6500

    Tübingen 2820860,
    Germany

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  • Site Number - 6503

    Ulm,
    Germany

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    Ulm 2820256,
    Germany

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    Würzburg,
    Germany

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    Würzburg 2805615,
    Germany

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  • Site Number - 3901

    Alexandroupoli 736928,
    Greece

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    Greece

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    Athens,
    Greece

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    Athens 264371,
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    Greece

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    Chaïdári 260183,
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    Heraklion,
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    Heraklion 261745,
    Greece

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    Ioannina 261779,
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    Larissa 258576,
    Greece

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    Patras,
    Greece

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    Pátrai 255683,
    Greece

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    Budapest,
    Hungary

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    Budapest 3054643,
    Hungary

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    Kistarcsa,
    Hungary

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    Kistarcsa 3050290,
    Hungary

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  • Site Number - 7552

    Pécs,
    Hungary

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  • Site Number - 7552

    Pécs 3046526,
    Hungary

    Active - Recruiting

  • Site Number - 4100

    Waterford,
    Ireland

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  • Site Number - 4100

    Waterford 2960992,
    Ireland

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  • Site Number - 6004

    Bergamo,
    Italy

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    Bergamo 3182164,
    Italy

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  • Site Number - 6007

    Bologna,
    Italy

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    Bologna 3181928,
    Italy

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  • Site Number - 6000

    Brescia,
    Italy

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  • Site Number - 6000

    Brescia 3181554,
    Italy

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  • Site Number - 6009

    Milan,
    Italy

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  • Site Number - 6009

    Milan 3173435,
    Italy

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  • Site Number - 6001

    Milan 6951411,
    Italy

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  • Site Number -6005

    Milan 6951411,
    Italy

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  • Site Number - 6001

    Milano,
    Italy

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  • Site Number -6005

    Milano,
    Italy

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  • Site Number - 6011

    Pavia,
    Italy

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  • Site Number - 6011

    Pavia 3171366,
    Italy

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  • Site Number - 6010

    Pisa,
    Italy

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  • Site Number - 6010

    Pisa 3170647,
    Italy

    Site Not Available

  • Site Number - 6002

    Roma,
    Italy

    Site Not Available

  • Site Number - 6006

    Roma,
    Italy

    Site Not Available

  • Site Number - 6002

    Roma 8957247,
    Italy

    Site Not Available

  • Site Number - 6006

    Roma 8957247,
    Italy

    Active - Recruiting

  • Site Number - 6003

    Siena,
    Italy

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  • Site Number - 6003

    Siena 3166548,
    Italy

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  • Site Number - 2603

    Colonia Del Valle,
    Mexico

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  • Site Number - 2603

    Colonia del Valle 7280708,
    Mexico

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  • Site Number - 2600

    Culiacán,
    Mexico

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  • Site Number - 2600

    Culiacán 4012176,
    Mexico

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  • Site Number - 2602

    Tlalpan,
    Mexico

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  • Site Number - 2602

    Tlalpan 3515428,
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  • Site Number - 2601

    Veracruz,
    Mexico

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    Veracruz 3514783,
    Mexico

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  • Site Number - 2200

    Utrecht,
    Netherlands

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  • Site Number - 2200

    Utrecht 2745912,
    Netherlands

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  • Site Number - 2300

    Oslo,
    Norway

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  • Site Number - 2300

    Oslo 3143244,
    Norway

    Active - Recruiting

  • Site Number - 2401

    Callao,
    Peru

    Site Not Available

  • Site Number - 2401

    Callao 3946083,
    Peru

    Site Not Available

  • Site Number - 2400

    Lima,
    Peru

    Site Not Available

  • Site Number - 2400

    Lima 3936456,
    Peru

    Site Not Available

  • Site Number - 3007

    Bydgoszcz,
    Poland

    Site Not Available

  • Site Number - 3007

    Bydgoszcz 3102014,
    Poland

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  • Site Number - 3008

    Gdansk 3099434,
    Poland

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  • Site Number - 3008

    Gdańsk,
    Poland

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  • Site Number - 3004

    Katowice,
    Poland

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  • Site Number - 3004

    Katowice 3096472,
    Poland

    Active - Recruiting

  • Site Number - 3000

    Krakow 3094802,
    Poland

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  • Site Number - 3003

    Krakow 3094802,
    Poland

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  • Site Number - 3000

    Kraków,
    Poland

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  • Site Number - 3003

    Kraków,
    Poland

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  • Site Number - 3001

    Lublin,
    Poland

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  • Site Number - 3005

    Lublin,
    Poland

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  • Site Number - 3001

    Lublin 765876,
    Poland

    Active - Recruiting

  • Site Number - 3005

    Lublin 765876,
    Poland

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  • Site Number - 3002

    Poznan 3088171,
    Poland

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  • Site Number - 3002

    Poznań,
    Poland

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  • Site Number - 3006

    Warsaw 756135,
    Poland

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  • Site Number - 3006

    Warszawa,
    Poland

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  • Site Number -2902

    Almada,
    Portugal

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  • Site Number -2902

    Almada 2271961,
    Portugal

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  • Site Number - 2901

    Matosinhos,
    Portugal

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  • Site Number - 2901

    Matosinhos Municipality 2737824,
    Portugal

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  • Site Number - 2903

    Vila Nova De Gaia,
    Portugal

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  • Site Number - 2903

    Vila Nova de Gaia 2732544,
    Portugal

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  • Site Number - 7503

    Bucharest 683506,
    Romania

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  • Site Number - 7503

    Bucuresti,
    Romania

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  • Site Number - 7500

    Constanţa,
    Romania

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  • Site Number - 7500

    Constanța 680963,
    Romania

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  • Site Number - 9000

    Belgrade,
    Serbia

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  • Site Number - 9003

    Belgrade,
    Serbia

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  • Site Number - 9000

    Belgrade 792680,
    Serbia

    Active - Recruiting

  • Site Number - 9003

    Belgrade 792680,
    Serbia

    Site Not Available

  • Site Number -9002

    Kragujevac,
    Serbia

    Site Not Available

  • Site Number -9002

    Kragujevac 789128,
    Serbia

    Active - Recruiting

  • Site Number - 9001

    Niš,
    Serbia

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  • Site Number - 9001

    Niš 787657,
    Serbia

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  • Site Number - 2800

    Martin,
    Slovakia

    Site Not Available

  • Site Number - 2800

    Martin 3058780,
    Slovakia

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  • Site Number - 2802

    Prešov,
    Slovakia

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  • Site Number - 2802

    Prešov 723819,
    Slovakia

    Active - Recruiting

  • Site Number - 2801

    Rimavská Sobota,
    Slovakia

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  • Site Number - 2801

    Rimavská Sobota 723736,
    Slovakia

    Active - Recruiting

  • Site Number - 7351

    Ljubljana,
    Slovenia

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  • Site Number - 7351

    Ljubljana 3196359,
    Slovenia

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  • Site Number - 7100

    Barcelona,
    Spain

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  • Site Number - 7101

    Barcelona,
    Spain

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    Barcelona 3128760,
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  • Site Number - 7101

    Barcelona 3128760,
    Spain

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  • Site Number - 7104

    Bilbao,
    Spain

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    Bilbao 3128026,
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    Córdoba,
    Spain

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    Córdoba 2519240,
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    Santiago De Compostela,
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    Santiago de Compostela 3109642,
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    Bakırköy,
    Turkey

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    Turkey

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    Bursa,
    Turkey

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    Turkey

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    Turkey

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    Turkey

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    Bakırköy 751213,
    Turkey (Türkiye)

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    Başakşehir 6947639,
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    Bursa 750269,
    Turkey (Türkiye)

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    Samsun 740264,
    Turkey (Türkiye)

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    Bristol,
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    Bristol 2654675,
    United Kingdom

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    United Kingdom

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    United Kingdom

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    United Kingdom

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    Salford 2638671,
    United Kingdom

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    Tucson, Arizona 85718
    United States

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    Rancho Mirage, California 92270
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    Washington D.C. 4140963, District of Columbia 4138106 20037
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    Washington D.C. 4140963, District of Columbia 4138106 20010
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    Boston 4930956, Massachusetts 6254926 02114
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    Site Not Available

  • Site Number - 1627

    New York, New York 10065
    United States

    Site Not Available

  • Site Number - 1605

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Site Number - 1627

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Site Number - 1635

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Site Number - 1610

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Site Number - 1635

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • Site Number - 1610

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Site Number - 1624

    Canton, Ohio 44718
    United States

    Site Not Available

  • Site Number - 1624

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • Site Number - 1631

    Yukon, Oklahoma 73099
    United States

    Site Not Available

  • Site Number - 1631

    Yukon 4556165, Oklahoma 4544379 73099
    United States

    Active - Recruiting

  • Site Number - 1614

    Portland, Oregon 97239
    United States

    Site Not Available

  • Site Number - 1614

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Site Number - 1616

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Site Number - 1616

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • Site Number - 1622

    Houston, Texas 77030
    United States

    Site Not Available

  • Site Number - 1628

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Site Number - 1622

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Site Number - 1628

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Site Number - 1613

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Site Number - 1613

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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