A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

Last updated: July 16, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Warts

Eczema (Atopic Dermatitis)

Atopic Dermatitis

Treatment

Placebo

Povorcitinib

Clinical Study ID

NCT06516965
INCB54707-306
2024-511881-35-00
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants 18 to 75 years of age.

  • Clinical diagnosis of PN for at least 3 months prior to Screening visit.

  • Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.

  • Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/orboth arms, and/or trunk) at Screening and Day 1/Baseline.

  • Documented history of treatment failure, demonstrated intolerance, orcontraindication to a previous PN treatment.

  • Willingness to avoid pregnancy or fathering children.

Exclusion

Exclusion Criteria:

  • Chronic pruritus due to a condition other than PN or neuropathic and psychogenicpruritus.

  • Diagnosis of PN secondary to medications.

  • Active AD lesions (signs and symptoms other than dry skin) within 3 months prior toScreening visit.

  • Women who are pregnant (or are considering pregnancy) or breastfeeding.

  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction;venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke,moderate to severe heart failure, cerebrovascular accident, myocardial infarction,or other significant cardiovascular diseases; Q-wave interval abnormalities;disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex;chronic/recurrent infections; malignancies.

  • Evidence of infection with TB, HBV, HCV or HIV.

  • History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment ofPN or any inflammatory disease.

  • Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 10, 2024
Estimated Completion Date:
June 02, 2027

Connect with a study center

  • Dermatology Associates Pc

    Rockville, Maryland 20850
    United States

    Active - Recruiting

    15.99 miles

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

    35.55 miles

  • Paddington Testing Co Inc

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

    123.39 miles

  • Yardley Dermatology Associates

    Yardley, Pennsylvania 19067
    United States

    Active - Recruiting

    148.83 miles

  • West Virginia Research Institute

    Morgantown, West Virginia 26505
    United States

    Site Not Available

    164.33 miles

  • Suny Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

    204.51 miles

  • OPTISKIN

    New York, New York 10128
    United States

    Active - Recruiting

    209.27 miles

  • Schweiger Dermatology

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

    210.03 miles

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

    216.47 miles

  • Oakview Dermatology

    Athens, Ohio 45701
    United States

    Site Not Available

    272.23 miles

  • Centricity Research Aventiv Research Dublin

    Dublin, Ohio 43016
    United States

    Site Not Available

    336.88 miles

  • Toronto Research Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Active - Recruiting

    356.48 miles

  • North York Research Inc.

    Toronto, Ontario M2N 3A6
    Canada

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    356.48 miles

  • Dermeffects

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    Canada

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    358.27 miles

  • University of Cincinnati Health Physicians

    Cincinnati, Ohio 45213
    United States

    Site Not Available

    396.89 miles

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

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    397.86 miles

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    Cincinnati, Ohio 45267
    United States

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    401.32 miles

  • Simcoderm Medical and Surgical Dermatology Centre

    Barrie, Ontario L4M 7G1
    Canada

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    402.48 miles

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

    406.26 miles

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    Waterford, Michigan 48328
    United States

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    420.3 miles

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    Clarkston, Michigan 48346
    United States

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    426.17 miles

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    United States

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    426.29 miles

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    434.49 miles

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    United States

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    463.04 miles

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    473.23 miles

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    United States

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    477.71 miles

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    United States

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    550.82 miles

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    594.83 miles

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    621.43 miles

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    United States

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    816.69 miles

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    United States

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    United States

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    United States

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    United States

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    950.71 miles

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    United States

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    964.52 miles

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    United States

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    1,149.2 miles

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    Dallas, Texas 75231
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    1,176.36 miles

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    1,684.26 miles

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    1,842.6 miles

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    1,975.91 miles

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    Canada

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    Los Angeles, California 90045
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    2,305.16 miles

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    2,307.31 miles

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    2,321.18 miles

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    United States

    Site Not Available

    2,321.18 miles

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    2,368.94 miles

  • Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag

    Santiago de Compostela, 15706
    Spain

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    3,487.6 miles

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    Liverpool, L14 3LB
    United Kingdom

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    3,511.64 miles

  • Harrogate District Hospital - Harrogate and District Nhs Foundation Trust

    Harrogate, HG2 7SX
    United Kingdom

    Site Not Available

    3,558.25 miles

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    Dudley, DY1 2HQ
    United Kingdom

    Active - Recruiting

    3,564.7 miles

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    Poole, BH15 2JB
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    3,605.51 miles

  • Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

    London, SE1 9RT
    United Kingdom

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    3,665.01 miles

  • The Royal London Hospital - Barts Health Nhs Trust

    London, E1 1FR
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    3,665.01 miles

  • Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital

    Redhill,
    United Kingdom

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    3,669.04 miles

  • Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

    Colchester, CO4 5JL
    United Kingdom

    Site Not Available

    3,698.34 miles

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    Ipswich, IP4 5PD
    United Kingdom

    Active - Recruiting

    3,704.77 miles

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222
    Spain

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    3,773.43 miles

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222
    Spain

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    3,773.43 miles

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

    3,783.11 miles

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

    3,783.11 miles

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

    3,783.11 miles

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Active - Recruiting

    3,803.74 miles

  • UZ GENT

    Gent, 09000
    Belgium

    Active - Recruiting

    3,832.26 miles

  • Az Sint Lucas Gent-Campus Sint Lucas

    Gent, 09000
    Belgium

    Site Not Available

    3,832.26 miles

  • Universitair Ziekenhuis Gent (Uz Gent)

    Gent, 09000
    Belgium

    Active - Recruiting

    3,832.26 miles

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650
    Belgium

    Site Not Available

    3,859.12 miles

  • Universitair Ziekenhuis Antwerpen

    Edegem, 02650
    Belgium

    Site Not Available

    3,859.12 miles

  • Hospital Clinico Universitario San Cecilio

    Granada, 18016
    Spain

    Active - Recruiting

    3,883.1 miles

  • Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman

    Liege, 04000
    Belgium

    Active - Recruiting

    3,917.62 miles

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 04000
    Belgium

    Active - Recruiting

    3,917.62 miles

  • University Hospital Rwth Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

    3,934.71 miles

  • Aachen University Hospital

    Aachen, 52074
    Germany

    Active - Recruiting

    3,934.71 miles

  • Klinikum Oldenburg Aor

    Oldenburg, 26133
    Germany

    Active - Recruiting

    3,955.05 miles

  • Hospital de Manises

    Manises, 46940
    Spain

    Active - Recruiting

    3,966.51 miles

  • Hautarztpraxis Dr. Hoffmann

    Witten, 58453
    Germany

    Active - Recruiting

    3,966.87 miles

  • Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe (I

    Valencia, 46026
    Spain

    Active - Recruiting

    3,970.44 miles

  • Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

    3,970.44 miles

  • Hospital General Universitario Dr Balmis

    Alicante, 03010
    Spain

    Active - Recruiting

    3,999.81 miles

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

    3,999.81 miles

  • Elbe Kliniken Buxtehude

    Buxtehude, 21614
    Germany

    Active - Recruiting

    4,002.48 miles

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

    4,032.97 miles

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

    4,034.05 miles

  • Hospital Universitari Germans Trias I Pujol (Hugtp)

    Badalona, 08916
    Spain

    Active - Recruiting

    4,034.05 miles

  • Dermatologische Gemeinschaftspraxis Dres. Quist

    Mainz, 55128
    Germany

    Active - Recruiting

    4,044.77 miles

  • Rosenpark Research

    Darmstadt, 64283
    Germany

    Active - Recruiting

    4,063.58 miles

  • Klinikum Darmstadt

    Darmstadt, 64283
    Germany

    Active - Recruiting

    4,063.58 miles

  • Rosenpark Research Gmbh

    Darmstadt, 64283
    Germany

    Active - Recruiting

    4,063.58 miles

  • Universitaetsmedizin Goettingen

    Gottingen, 37075
    Germany

    Active - Recruiting

    4,066.36 miles

  • Magdeburger Company For Medical Studies and Services Gmbh

    Magdeburg, 39104
    Germany

    Active - Recruiting

    4,114.68 miles

  • Drk Krankenhaus Chemnitz-Rabenstein

    Chemnitz, 09117
    Germany

    Active - Recruiting

    4,203.64 miles

  • University Hospital Carl Gustav Carus

    Dresden, 01307
    Germany

    Active - Recruiting

    4,228.69 miles

  • Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy

    Gdansk, 80-280
    Poland

    Active - Recruiting

    4,302.37 miles

  • Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa

    Poznan, 61-731
    Poland

    Active - Recruiting

    4,305.19 miles

  • Mics Centrum Medyczne Torun

    Torun, 87-100
    Poland

    Active - Recruiting

    4,345.88 miles

  • Mics Centrum Medyczne Toruń

    Torun, 87-100
    Poland

    Active - Recruiting

    4,345.88 miles

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

    Wroclaw, 50566
    Poland

    Active - Recruiting

    4,352.46 miles

  • Santa Familia Ptg Lodz

    Lodz, 90-302
    Poland

    Active - Recruiting

    4,419.76 miles

  • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436
    Poland

    Active - Recruiting

    4,419.76 miles

  • Care Clinic Sp. Z O.O.

    Katowice, 40-568
    Poland

    Active - Recruiting

    4,456.82 miles

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

    4,521.77 miles

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.

    Tarnow, 33-100
    Poland

    Site Not Available

    4,540.38 miles

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska

    Lublin, 20-573
    Poland

    Active - Recruiting

    4,552.73 miles

  • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

    Rzeszow, 35-055
    Poland

    Active - Recruiting

    4,577.44 miles

  • Centro Internacional de Estudios Clinicos

    Santiago, 8420383
    Chile

    Active - Recruiting

    5,013.82 miles

  • Clinical Research Chile Spa.

    Valdivia, 5090000
    Chile

    Active - Recruiting

    5,442.94 miles

  • Sapporo Skin Clinic

    Sapporo, 600063
    Japan

    Active - Recruiting

    6,285.51 miles

  • Tohoku University Hospital

    Sendai, 980-8574
    Japan

    Active - Recruiting

    6,588.19 miles

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520
    Japan

    Active - Recruiting

    6,656.57 miles

  • Tokyo Medical and Dental University Hospital, Faculty of Medicine

    Bunkyo-ku, 113-8519
    Japan

    Active - Recruiting

    6,773.11 miles

  • Tanpopo Dermatology Clinic

    Ota-ku, 143-0023
    Japan

    Active - Recruiting

    6,783.01 miles

  • Jun Skin Clinic

    Osaka, 558-0014
    Japan

    Site Not Available

    6,943.31 miles

  • Medical Corporation Jun Dermatology Clinic

    Osaka, 558-0003
    Japan

    Active - Recruiting

    6,943.31 miles

  • Shimizu Dermatology Clinic

    Kobe, 657-0846
    Japan

    Active - Recruiting

    6,950.94 miles

  • University of Occupational and Environmental Health, Japan

    Kitakyushu, 807-8555
    Japan

    Active - Recruiting

    7,100.06 miles

  • Novatrials

    Newcastle, New South Wales 02289
    Australia

    Active - Recruiting

    9,707.7 miles

  • Skin & Cancer Foundation Australia

    Sydney, New South Wales 02010
    Australia

    Active - Recruiting

    9,761.55 miles

  • The Alfred Hospital

    Melbourne, Victoria 03004
    Australia

    Site Not Available

    10,179.95 miles

  • Klinikum Der Johann Wolfgang Goethe University

    Frankfurt Am Main, 60590
    Germany

    Active - Recruiting

  • University Hospital Muenster

    Muenster, 48149
    Germany

    Active - Recruiting

  • First Oc Dermatology Research Inc

    Fountain Valley, California 92708-3701
    United States

    Active - Recruiting

  • Acclaim Dermatology, Pllc

    Sugar Land, Texas 77479-2645
    United States

    Site Not Available

  • Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum

    Inashiki-gun,
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Minamikoshigaya, 343-8555
    Japan

    Active - Recruiting

  • High-Med. Przychodnia Specjalistyczna

    Warszawa, 01-817
    Poland

    Active - Recruiting

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135-3511
    United States

    Active - Recruiting

  • Equity Medical, Llc

    New York, New York 100233
    United States

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Wolloongabba, Queensland 04102
    Australia

    Active - Recruiting

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales 02217
    Australia

    Active - Recruiting

  • Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan

    Brugge, 08000
    Belgium

    Site Not Available

  • Klinikum Der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt Am Main, 60590
    Germany

    Site Not Available

  • Technischen Universitaet Muenchen

    Muenchen, 80802
    Germany

    Active - Recruiting

  • Noguchi Dermatology Clinic

    Kamimashiki-gun, 861-3101
    Japan

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • National Defence Medical College Hospital

    Tokorozawa-shi, 359-8513
    Japan

    Active - Recruiting

  • Skin Care Research, Llc Scr Hollywood

    Hollywood, Florida 33201
    United States

    Active - Recruiting

  • Cliniques Universitaires Ucl Saint-Luc

    Woluwe-saint-lambert, 01200
    Belgium

    Active - Recruiting

  • Klinikum Der Johann Wolfgang Goethe-Universitaet

    Frankfurt Am Main, 60590
    Germany

    Active - Recruiting

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki-shi, 211-8533
    Japan

    Active - Recruiting

  • Kume Derma Clinic

    Sakai, 593-8324
    Japan

    Active - Recruiting

  • Panstwowy Instytut Medyczny Mswia

    Warszawa, 02-507
    Poland

    Active - Recruiting

  • Skin Care Research, Llc

    Hollywood, Florida 33201
    United States

    Active - Recruiting

  • Fremantle Dermatology

    Fremantle, 06160
    Australia

    Active - Recruiting

  • Grand Hopital de Charleroi

    Loverval, 06280
    Belgium

    Active - Recruiting

  • Grand Hopital de Charleroi ¿ Site Imtr

    Loverval, 06280
    Belgium

    Active - Recruiting

  • Royalderm Agnieszka Nawrocka

    Warszawa, 02-692
    Poland

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 02145
    Australia

    Active - Recruiting

  • Centro Medico Skinmed Limitada

    LAS Condes Santiago, 7580206
    Chile

    Active - Recruiting

  • Clintrial S.R.O.

    Prague, 100 00
    Czechia

    Active - Recruiting

  • Sanixtra Prague

    Praha 13-stodulky, 158 00
    Czechia

    Site Not Available

  • Az Sint-Jan Brugge Av

    Brugge, 08000
    Belgium

    Active - Recruiting

  • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

    Woluwe-saint-lambert, 01200
    Belgium

    Active - Recruiting

  • Sanatorium Profesora Arenbergera

    Prague, 110 00
    Czechia

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023
    Japan

    Active - Recruiting

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