Level Up: A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05601882
Collaborator
(none)
880
298
2
33.9
3
0.1

Study Details

Study Description

Brief Summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
880 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)
Actual Study Start Date :
Nov 28, 2022
Anticipated Primary Completion Date :
May 7, 2025
Anticipated Study Completion Date :
Sep 25, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Upadacitinib

Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.

Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
  • Experimental: Dupilumab followed by Upadacitinib

    Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.

    Drug: Upadacitinib
    Oral Tablets
    Other Names:
  • RINVOQ
  • Drug: Dupilumab
    Subcutaneous Injection

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1) [At week 16]

      The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72. The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90) [Up to week 16]

      The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.

    2. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1 [Up to week 16]

      The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.

    3. Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 among those with Baseline WP-NRS ≥ 4 [At week 16]

      The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.

    4. Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75) [At week 2]

      The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.

    5. Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100) [At week 16]

      The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.

    • Eczema area and severity index (EASI) score ≥ 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.

    • Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4.

    • Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

    Exclusion Criteria:
    • History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

    • History of an organ transplant which requires continued immunosuppression.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Dermatology Specialist /ID# 250212 Phoenix Arizona United States 85006-2722
    2 Alliance Dermatology and MOH Center, PC /ID# 249671 Phoenix Arizona United States 85032
    3 Clinical Trials Institute at Northwest Arkansas /ID# 249838 Fayetteville Arkansas United States 72703-6245
    4 Arkansas Research Trials, LLC /ID# 250722 North Little Rock Arkansas United States 72117
    5 Encino Research Center /ID# 250211 Encino California United States 91436
    6 First OC Dermatology Research /ID# 250686 Fountain Valley California United States 92708-3701
    7 Antelope Valley Clinical Trials /ID# 249946 Lancaster California United States 93534
    8 Dermatology Research Associates /ID# 249829 Los Angeles California United States 90045
    9 UC Davis Health /ID# 250044 Sacramento California United States 95816-3300
    10 Stanford University /ID# 251211 Stanford California United States 94305
    11 California Dermatology Institute /ID# 250213 Thousand Oaks California United States 91320-2130
    12 Western States Clinical Res /ID# 250274 Wheat Ridge Colorado United States 80033-2896
    13 Clearlyderm Dermatology /ID# 250457 Boca Raton Florida United States 33428
    14 Skin Care Research - Boca Raton /ID# 250458 Boca Raton Florida United States 33486-2269
    15 Olympian Clinical Research /ID# 250453 Clearwater Florida United States 33756
    16 Skin Care Research - Hollywood /ID# 250459 Hollywood Florida United States 33021-6748
    17 Solutions Through Adv Rch /ID# 250455 Jacksonville Florida United States 32256
    18 GSI Clinical Research, LLC /ID# 250768 Margate Florida United States 33063
    19 Wellness Clinical Research /ID# 250236 Miami Lakes Florida United States 33016
    20 D&H National Research Centers /ID# 250734 Miami Florida United States 33155-3244
    21 Florida International Rsrch cr /ID# 249667 Miami Florida United States 33173
    22 Tory P Sullivan, MD PA /ID# 251136 North Miami Beach Florida United States 33162-4708
    23 Precision Clinical Research /ID# 250990 Sunrise Florida United States 33351-7311
    24 Advanced Clinical Research Institute /ID# 250460 Tampa Florida United States 33607-6429
    25 Metabolic Research Inst /ID# 250046 West Palm Beach Florida United States 33401
    26 Treasure Valley Medical Research /ID# 250727 Boise Idaho United States 83706
    27 Dawes Fretzin, LLC /ID# 250276 Indianapolis Indiana United States 46256
    28 Randall Dermatology of West Lafayette /ID# 250234 West Lafayette Indiana United States 47906-1569
    29 Beth Israel Deaconess Medical Center /ID# 251212 Boston Massachusetts United States 02215-5400
    30 Beacon Clinical Research, LLC /ID# 251412 Quincy Massachusetts United States 02169
    31 Michigan Center for Research Company /ID# 250225 Clarkston Michigan United States 48346
    32 Henry Ford Medical Center /ID# 250228 Detroit Michigan United States 48202-3046
    33 Cleaver Dermatology /ID# 250725 Kirksville Missouri United States 63501-5362
    34 MediSearch Clinical Trials /ID# 250272 Saint Joseph Missouri United States 64506
    35 Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616 Lincoln Nebraska United States 68505-2343
    36 Physician Research Collaboration, LLC /ID# 251099 Lincoln Nebraska United States 68516
    37 Montefiore Medical Center - Moses Campus /ID# 251214 Bronx New York United States 10467
    38 Derm of Greater Columbus /ID# 250049 Bexley Ohio United States 43209-2422
    39 Univ Hosp Cleveland /ID# 250699 Cleveland Ohio United States 44106
    40 Vital Prospects Clinical Research Institute, PC /ID# 249840 Tulsa Oklahoma United States 74136-7049
    41 Oregon Dermatology and Research Center /ID# 250726 Portland Oregon United States 97210
    42 Oregon Medical Res Center PC /ID# 249666 Portland Oregon United States 97223
    43 Oregon Health and Science University /ID# 250712 Portland Oregon United States 97239
    44 University of Pittsburgh MC /ID# 251208 Pittsburgh Pennsylvania United States 15260
    45 MUSC - Rutledge Tower /ID# 251218 Charleston South Carolina United States 29425-8903
    46 Health Concepts /ID# 250988 Rapid City South Dakota United States 57702
    47 International Clinical Research - Tennessee LLC /ID# 250724 Murfreesboro Tennessee United States 37130-2450
    48 Arlington Research Center, Inc /ID# 250468 Arlington Texas United States 76011
    49 Orion Clinical Research /ID# 250473 Austin Texas United States 78759-4100
    50 Bellaire Dermatology Associates /ID# 250739 Bellaire Texas United States 77401
    51 Modern Research Associates, PLLC /ID# 250688 Dallas Texas United States 75231
    52 University of Texas Health Science Center at Houston /ID# 250736 Houston Texas United States 77030-1501
    53 Center for Clinical Studies /ID# 250039 Houston Texas United States 77065
    54 Texas Dermatology and Laser Specialists /ID# 250367 San Antonio Texas United States 78218-3128
    55 University of Utah Mid Valley Dermatology /ID# 250042 Murray Utah United States 84107-7302
    56 Virginia Clinical Research, Inc. /ID# 249908 Norfolk Virginia United States 23507
    57 Framingham Centro Medico /ID# 251031 La Plata Buenos Aires Argentina 1902
    58 Hospital Universitario Austral /ID# 251030 Pilar Buenos Aires Argentina 1629
    59 Fundacion CIDEA /ID# 250023 Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires Argentina 1121
    60 Instituto de Neumonología y Dermatología /ID# 250088 Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires Argentina 1425
    61 Instituto de Diagnostico ABC /ID# 250144 Rosario Santa Fe Argentina 2000
    62 Centro de Investigaciones Medicas Tucuman /ID# 250024 San Miguel de Tucuman Tucuman Argentina 4000
    63 Sanatorio 9 de Julio /ID# 250705 San Miguel de Tucuman Tucuman Argentina 4000
    64 Hospital Italiano /ID# 250182 Caba Argentina C1199ABB
    65 Parra Dermatologia /ID# 251058 Mendoza Argentina 5500
    66 Premier Specialist /ID# 250572 Kogarah New South Wales Australia 2217
    67 Veracity Clinical Research /ID# 249943 Woolloongabba Queensland Australia 4102
    68 Skin Health Institute Inc /ID# 249938 Carlton Victoria Australia 3053
    69 Sinclair Dermatology /ID# 249937 East Melbourne Victoria Australia 3002
    70 Fremantle Dermatology /ID# 249941 Fremantle Western Australia Australia 6160
    71 UCL Saint-Luc /ID# 251403 Woluwe-Saint-Lambert Bruxelles-Capitale Belgium 1200
    72 Grand Hopital de Charleroi /ID# 251401 Charleroi Hainaut Belgium 6000
    73 Universitair Ziekenhuis Leuven /ID# 251399 Leuven Vlaams-Brabant Belgium 3000
    74 CHU de Liege /ID# 251400 Liege Belgium 4000
    75 UMHAT Dr Georgi Stranski EAD /ID# 251268 Pleven Bulgaria 5800
    76 DCC "Pulmed" AD /ID# 251271 Plovdiv Bulgaria 4001
    77 ASMC-IPSMC-Skin and Venereal Diseases /ID# 251272 Sofia Bulgaria 1407
    78 Diagnostic consultative center Aleksandrovska /ID# 251137 Sofia Bulgaria 1431
    79 Diagnostic consultative center Focus-5 /ID# 251269 Sofia Bulgaria 1463
    80 Medical center EuroHealth /ID# 251270 Sofia Bulgaria 1606
    81 Military Medical Academy Multiprofile Hospital /ID# 251187 Sofia Bulgaria 1606
    82 Medical Center Euroderma /ID# 251267 Sofiya Bulgaria 1606
    83 MC Zara-Med EOOD /ID# 251135 Stara Zagora Bulgaria 6000
    84 Dermatology Research Institute Inc. /ID# 251642 Calgary Alberta Canada T2J 7E1
    85 Beacon Dermatology Inc /ID# 250336 Calgary Alberta Canada T3E 0B2
    86 Alberta DermaSurgery Centre /ID# 250217 Edmonton Alberta Canada T6G 1C3
    87 Dr. Chih-ho Hong Medical Inc. /ID# 251643 Surrey British Columbia Canada V3R 6A7
    88 Enverus Medical Research /ID# 251645 Surrey British Columbia Canada V3V 0C6
    89 UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 250218 Vancouver British Columbia Canada V5Z 4E8
    90 Wiseman Dermatology Research /ID# 250219 Winnipeg Manitoba Canada R3M 3Z4
    91 Brunswick Dermatology Center /ID# 250220 Fredericton New Brunswick Canada E3B 1G9
    92 LEADER Research /ID# 251647 Hamilton Ontario Canada L8L 3C3
    93 DermEffects /ID# 250223 London Ontario Canada N6H 5L5
    94 Lynderm Research Inc. /ID# 251854 Markham Ontario Canada L3P 1X2
    95 DermEdge Research Inc. /ID# 250216 Mississauga Ontario Canada L4Y 4C5
    96 SKIN Centre for Dermatology /ID# 251853 Peterborough Ontario Canada K9J 5K2
    97 Toronto Research Centre /ID# 252098 Toronto Ontario Canada M3H 5Y8
    98 Research Toronto /ID# 250222 Toronto Ontario Canada M4W 2N4
    99 K. Papp Clinical Research /ID# 251644 Waterloo Ontario Canada N2J 1C4
    100 Centre de recheche dermatologique du Quebec Metropolitain /ID# 250427 Québec Quebec Canada G1V 4X7
    101 Beijing Friendship Hospital /ID# 249399 Beijing Beijing China 100032
    102 Guangzhou First People's Hospital /ID# 249695 Guangzhou Guangdong China 510180
    103 The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694 Guangzhou Guangdong China 510260
    104 The University of Hong Kong- Shenzhen Hospital /ID# 249436 Shenzhen Guangdong China 518048
    105 Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485 Wuhan Hubei China 430022
    106 Wuhan Integrated TCM & Western Medicine Hospital(Wuhan No.1 Hospital) /ID# 250019 Wuhan Hubei China 430022
    107 The First Hospital of China Medical University /ID# 249638 Shenyang Liaoning China 110001
    108 Huashan Hospital, Fudan University /ID# 250025 Shanghai Shanghai China 200040
    109 Shanghai Skin Disease Hospital /ID# 249392 Shanghai Shanghai China 200443
    110 Tianjin Medical University General Hospital /ID# 250246 Tianjin Tianjin China 300052
    111 Hangzhou First People's Hospital /ID# 249437 Hangzhou Zhejiang China 310003
    112 The second Affiliated hospital of Zhejiang University school of Medicine /ID# 249655 Hangzhou Zhejiang China 310009
    113 Zhejiang Provincial People's Hospital /ID# 249653 Hangzhou Zhejiang China 310014
    114 The Second Xiangya Hospital of Central South University /ID# 249657 Changsha China 410011
    115 The First Affiliated Hospital of Fujian Medical University /ID# 249674 Fuzhou China 350005
    116 Dermatology Hospital of Southern Medical University /ID# 250121 Guangzhou China 510091
    117 Clinisalud del sur /ID# 251951 Medellin Antioquia Colombia 055422
    118 Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 251950 Barranquilla Atlantico Colombia 80002
    119 Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 251952 Bogota Cundinamarca Colombia 110221
    120 Healthy Medical Center SAS /ID# 251953 Zipaquira Cundinamarca Colombia 250252
    121 Hospital Alma Mater de Antioquia /ID# 252020 Medellin Distrito Capital De Bogota Colombia 50010
    122 DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591 Zagreb Grad Zagreb Croatia 10000
    123 Djecja bolnica Srebrnjak /ID# 249594 Zagreb Grad Zagreb Croatia 10000
    124 Klinicki bolnicki centar Zagreb /ID# 249596 Zagreb Grad Zagreb Croatia 10000
    125 Klinika za dječje bolesti Zagreb /ID# 249590 Zagreb Grad Zagreb Croatia 10000
    126 Klinicki bolnicki centar Rijeka /ID# 249593 Rijeka Primorsko-goranska Zupanija Croatia 51000
    127 Klinicki bolnicki centar Split /ID# 249879 Split Splitsko-dalmatinska Zupanija Croatia 21000
    128 Poliklinika Solmed /ID# 252138 Grad Zagreb Croatia 10000
    129 Fakultni Nemocnice Brno /ID# 249993 Brno Czechia 625 00
    130 DERMAMEDICA, s.r.o. /ID# 251732 Cerveny Kostelec Czechia 549 41
    131 Nemocnice AGEL Novy Jicin, a.s. /ID# 249873 Novy Jicin Czechia 741 01
    132 CCR Ostrava, s.r.o. /ID# 249872 Ostrava Czechia 702 00
    133 Fakultni Nemocnice v Motole /ID# 251731 Praha Czechia 150 06
    134 Nemocnice Znojmo /ID# 250027 Znojmo Czechia 669 02
    135 Bispebjerg and Frederiksberg Hospital /ID# 248902 Copenhagen NV Hovedstaden Denmark 2400
    136 Herlev and Gentofte Hospital /ID# 248900 Hellerup Hovedstaden Denmark 2900
    137 Aarhus University Hospital /ID# 248899 Aarhus N Midtjylland Denmark 8200
    138 Sjællands Universitetshospital /ID# 248901 Roskilde Sjælland Denmark 4000
    139 HCL - Hopital Lyon Sud /ID# 251343 Pierre Benite CEDEX Auvergne-Rhone-Alpes France 69495
    140 Hopital Saint Joseph /ID# 251053 Marseille Bouches-du-Rhone France 13008
    141 CHU de Nantes, Hotel Dieu -HME /ID# 251347 Nantes Pays-de-la-Loire France 44000
    142 AP-HP - Hopital Saint-Louis /ID# 251052 Paris France 75010
    143 Hôpital Charles-Nicolle /ID# 251055 Rouen France 76000
    144 CHU Toulouse - Hopital Larrey /ID# 251344 Toulouse France 31400
    145 Universitaetsklinikum Freiburg /ID# 249555 Freiburg Baden-Wuerttemberg Germany 79106
    146 Universitaetsklinik Heidelberg /ID# 251458 Heidelberg Baden-Wuerttemberg Germany 69120
    147 Universitaetsklinikum Tuebingen /ID# 249552 Tubingen Baden-Wuerttemberg Germany 72076
    148 Universitaetsklinikum Frankfurt /ID# 249544 Frankfurt am Main Hessen Germany 60590
    149 Universitaetsklinikum Muenster /ID# 249404 Muenster Nordrhein-Westfalen Germany 48149
    150 Universitaetsklinikum Leipzig /ID# 249562 Leipzig Sachsen Germany 04103
    151 Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560 Lübeck Schleswig-Holstein Germany 23538
    152 Fachklinik Bad Bentheim /ID# 249545 Bad Bentheim Germany 48455
    153 Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566 Bochum Germany 44793
    154 Universitaetsklinikum Bonn /ID# 250307 Bonn Germany 53127
    155 Studiengesellschaft an der Hase GbR Praxis Weyergraf/Frick/Heiber /ID# 251392 Bramsche Germany 49565
    156 Klinikum Darmstadt /ID# 251391 Darmstadt Germany 64283
    157 Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844 Dresden Germany 01307
    158 Derma Study Center Friedrichshafen GmbH /ID# 251460 Friedrichshafen Germany 88045
    159 Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 249547 Hamburg Germany 20246
    160 Dermatologikum Hamburg GmbH /ID# 251390 Hamburg Germany 20354
    161 Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306 Mahlow Germany 15831
    162 Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 249549 Mainz Germany 55131
    163 Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 249548 Munich Germany 81675
    164 Klinikum Oldenburg GmbH /ID# 250344 Oldenburg Germany 26133
    165 401 GSNA - 401 Army General Hospital /ID# 251843 Athens Attiki Greece 11527
    166 General Hospital Andreas Syggros /ID# 251842 Athens Attiki Greece 16121
    167 Papageorgiou General Hospital Thessaloniki /ID# 251840 Stavroupoli (Thessalonikis) Thessaloniki Greece 55536
    168 Thessaloniki hospital for skin and venereal diseases- Ippokrateio Thessaloniki /ID# 252396 Thessaloniki Greece 54643
    169 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 249818 Szeged Csongrad Hungary 6725
    170 Debreceni Egyetem Klinikai Kozpont /ID# 249849 Debrecen Hajdu-Bihar Hungary 4032
    171 Bugat Pal Korhaz /ID# 251367 Gyöngyös Heves Hungary 3200
    172 Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 249848 Kaposvár Somogy Hungary 7400
    173 Clinexpert Kft /ID# 249822 Budapest Hungary 1033
    174 Semmelweis Egyetem /ID# 251368 Budapest Hungary 1085
    175 Uno Medical Trials Kft /ID# 249820 Budapest Hungary 1152
    176 Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 249819 Debrecen Hungary 4031
    177 Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 249850 Kecskemet Hungary 6000
    178 Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419 Pecs Hungary 7624
    179 Allergo-Derm Bakos Kft. /ID# 249821 Szolnok Hungary 5000
    180 Hadassah Medical Center-Hebrew University /ID# 251576 Jerusalem Yerushalayim Israel 91120
    181 Rabin Medical Center /ID# 251578 Petakh Tikva Israel 4941492
    182 Istituto Clinico Humanitas /ID# 251493 Rozzano Milano Italy 20089
    183 Fondazione PTV Policlinico Tor Vergata /ID# 250125 Rome Roma Italy 00133
    184 IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558 Rome Roma Italy 00144
    185 Azienda Ospedaliera di Perugia /ID# 251572 Perugia Umbria Italy 06129
    186 ASST Spedali civili di Brescia /ID# 250129 Brescia Italy 25123
    187 Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 250130 Cagliari Italy 09124
    188 CAST - Center for Advanced Studies and Technology /ID# 251495 Chieti Italy 66100
    189 Ospedale Piero Palagi /ID# 250206 Florence Italy 50122
    190 Presidio Ospedaliero San Salvatore /ID# 250127 L'Aquila Italy 67100
    191 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 250123 Milan Italy 20122
    192 Azienda Ospedaliero-Universitaria di Modena /ID# 250128 Modena Italy 41124
    193 AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 251557 Napoli Italy 80138
    194 Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 250124 Pisa Italy 56126
    195 Fondazione Policlinico Universitario Agostino Gemelli /ID# 251494 Roma Italy 00168
    196 Sapienza University of Rome - Polo Pontino /ID# 251571 Terracina Italy 04019
    197 A.O.U. Citta della Salute e della Scienza di Torino /ID# 250322 Turin Italy 10126
    198 Korea University Ansan Hospital /ID# 249814 Ansan Gyeonggido Korea, Republic of 15355
    199 Soonchunhyang University Hospital Bucheon /ID# 249812 Bucheon Gyeonggido Korea, Republic of 14584
    200 Ajou University Hospital /ID# 251491 Suwon Gyeonggido Korea, Republic of 16499
    201 KonKuk University Medical Center /ID# 249811 Seoul Seoul Teugbyeolsi Korea, Republic of 05030
    202 Pusan National University Hospital /ID# 249852 Busan Korea, Republic of 49241
    203 Kyungpook National University Hospital /ID# 249855 Daegu Korea, Republic of 41944
    204 Seoul National University Hospital /ID# 251492 Seoul Korea, Republic of 03080
    205 Chung-Ang University Hostipal /ID# 251490 Seoul Korea, Republic of 06973
    206 Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 249679 Monterrey Nuevo Leon Mexico 64460
    207 Eukarya PharmaSite, SC /ID# 249702 Monterrey Nuevo Leon Mexico 64718
    208 Cryptex Investigación Clínica S.A de C.V /ID# 249994 Mexico City Mexico 06100
    209 Hospital Infantil de Mexico Federico Gomez /ID# 249644 Mexico City Mexico 06720
    210 Centro de Dermatologia de Monterrey /ID# 249126 Monterrey Mexico 64460
    211 Clinical Research Institute SC /ID# 249647 Tlalnepantla de Baz Mexico 54055
    212 Arke SMO, S.A. de C.V. / Veracruz /ID# 250147 Veracruz Mexico 91910
    213 Bravis Ziekenhuis /ID# 251395 Bergen op Zoom Noord-Brabant Netherlands 4624 VT
    214 Academisch Medisch Centrum /ID# 251397 Amsterdam Netherlands 1105 AZ
    215 MICS Centrum Medyczne Torun /ID# 251433 Torun Kujawsko-pomorskie Poland 87-100
    216 Dermed Centrum Medyczne Sp. z o.o /ID# 251429 Lodz Lodzkie Poland 90-265
    217 Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082 Cracow Malopolskie Poland 30-438
    218 Diamond Clinic Sp. z o.o /ID# 249631 Cracow Malopolskie Poland 31-559
    219 Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437 Krakow Malopolskie Poland 31-011
    220 Klinika Ambroziak Sp. z o.o. /ID# 249406 Warsaw Mazowieckie Poland 02-758
    221 Royalderm Agnieszka Nawrocka /ID# 251432 Warszawa Mazowieckie Poland 02-962
    222 Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598 Iwonicz-Zdrój Podkarpackie Poland 38-440
    223 INTER CLINIC Piotr Adrian Klimiuk /ID# 251430 Bialystok Podlaskie Poland 15-077
    224 Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431 Gdansk Pomorskie Poland 80-546
    225 Centrum Kliniczno-Badawcze /ID# 251438 Elblag Warminsko-mazurskie Poland 82-300
    226 Solumed Centrum Medyczne /ID# 249641 Poznan Wielkopolskie Poland 60-529
    227 Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630 Cracow Poland 30-033
    228 Bodyclinic Sp. z o.o. sp.k. /ID# 249599 Warszawa Poland 03-712
    229 Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249196 Guimaraes Braga Portugal 4835-044
    230 Hospital Garcia de Orta, EPE /ID# 251455 Almada Portugal 2805-267
    231 CCA Braga - Hospital de Braga /ID# 250480 Braga Portugal 4710-243
    232 Centro Hospitalar de Leiria, EPE /ID# 249194 Leiria Portugal 2410-197
    233 Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 249195 Lisboa Portugal 1169-050
    234 Hospital dos Lusíadas Lisboa /ID# 251456 Lisboa Portugal 1500-458
    235 Hospital CUF Descobertas /ID# 249193 Lisboa Portugal 1998-018
    236 Unidade Local de Saúde de Matosinhos, EPE /ID# 249197 Matosinhos Portugal 4464-513
    237 Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191 Porto Portugal 4099-001
    238 Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192 Porto Portugal 4200-319
    239 Dr. Samuel Sanchez PSC /ID# 250389 Caguas Puerto Rico 00727
    240 Cruz-Santana, Carolina, PR /ID# 250393 Carolina Puerto Rico 00985
    241 Clinical Research Puerto Rico /ID# 250394 San Juan Puerto Rico 00909
    242 GCM Medical Group PSC /ID# 250391 San Juan Puerto Rico 00917-3104
    243 Bio Terra Med SRL /ID# 249624 Bucharest Bucuresti Romania 010701
    244 Centrul Medical de Diagnostic si Tratament SRI /ID# 249688 Bucharest Bucuresti Romania 011774
    245 Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 249625 Cluj Napoca Romania 400105
    246 Fakultna nemocnica Trnava /ID# 249745 Trnava Trnavsky Kraj Slovakia 917 75
    247 Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746 Bratislava Slovakia 811 09
    248 Derma therapy, spol. s r.o. /ID# 249783 Bratislava Slovakia 831 03
    249 BeneDerma s.r.o. /ID# 251791 Bratislava Slovakia 841 04
    250 Univerzitna nemocnica L. Pasteura Kosice /ID# 251790 Kosice Slovakia 040 01
    251 University of Pretoria /ID# 250208 Pretoria Gauteng South Africa 0001
    252 Dr Tshegofatso Mabelane /ID# 249697 Pretoria Gauteng South Africa 0181
    253 Asthma & Allergy Centre /ID# 250103 Westville Kwazulu-Natal South Africa 3629
    254 Spoke Research Inc /ID# 250091 CAPE TOWN Milnerton Western Cape South Africa 7441
    255 Allergy & Immunology (AIU) /ID# 249619 Cape Town Western Cape South Africa 7700
    256 Hospital Universitario Germans Trias i Pujol /ID# 251523 Badalona Barcelona Spain 08916
    257 Hospital Sant Joan de Deu /ID# 249602 Esplugues de Llobregat Barcelona Spain 08950
    258 Hospital Universitario Basurto /ID# 249784 Bilbao Vizcaya Spain 48013
    259 Hospital General Universitario de Alicante Doctor Balmis /ID# 251517 Alicante Spain 03010
    260 Hospital Universitario Virgen de las Nieves /ID# 249785 Granada Spain 18014
    261 Hospital Universitario La Paz /ID# 251518 Madrid Spain 28046
    262 Hospital Universitario Virgen Macarena /ID# 249603 Sevilla Spain 41009
    263 Hospital Universitario y Politecnico La Fe /ID# 251524 Valencia Spain 46026
    264 Skane University hospital /ID# 250332 Malmo Skane Lan Sweden 214 28
    265 Norrlands University hospital /ID# 250329 Umea Vasterbottens Lan Sweden 581 85
    266 Malarsjukhuset /ID# 251908 Eskilstuna Sweden 633 49
    267 Karolinska University Hospital /ID# 250328 Stockholm Sweden 171 76
    268 Universitätsspital Basel /ID# 250605 Basel Basel-Stadt Switzerland 4031
    269 Kantonsspital St. Gallen /ID# 250606 St. Gallen Sankt Gallen Switzerland 9007
    270 Universitatsspital Zurich /ID# 250607 Zurich Zuerich Switzerland 8091
    271 Inselspital, Universitätsspital Bern /ID# 250577 Bern Switzerland 3010
    272 Kaohsiung Chang Gung Memorial Hospital /ID# 249260 Kaohsiung City Kaohsiung Taiwan 833
    273 National Taiwan University Hospital - Hsinchu branch /ID# 249265 Hsinchu City Taiwan 30059
    274 Taipei Medical University Shuang Ho Hospital /ID# 249256 New Taipei City Taiwan 23561
    275 Taichung Veterans General Hospital /ID# 249261 Taichung Taiwan 40705
    276 National Taiwan University Hospital /ID# 249258 Taipei City Taiwan 100
    277 MacKay Memorial Hospital /ID# 249259 Taipei City Taiwan 10449
    278 Taipei Veterans General Hosp /ID# 249263 Taipei City Taiwan 11217
    279 Taipei Municipal Wan Fang Hospital /ID# 251500 Taipei Taiwan 116
    280 Linkou Chang Gung Memorial Hospital /ID# 249257 Taoyuan City Taiwan 333
    281 Erciyes University Medical Fac /ID# 249863 Melikgazi Kayseri Turkey 38030
    282 Ankara City Hospital /ID# 249870 Ankara Turkey 06800
    283 Akdeniz Universitesi Tip Fakul /ID# 249866 Antalya Turkey 07059
    284 Uludag University Medical Faculty /ID# 249864 Bursa Turkey 16059
    285 Gaziantep University Şahinbey Research and Practice Hospital /ID# 249868 Gaziantep Turkey 27310
    286 Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 249862 Istanbul Turkey 34098
    287 Ondokuz Mayis Universitesi Tip /ID# 249865 Samsun Turkey 55139
    288 Victoria Hospital /ID# 251758 Kirkcaldy Fife United Kingdom KY2 5AH
    289 Guys and St Thomas NHS Foundation Trust /ID# 250070 London London, City Of United Kingdom SE1 9RT
    290 Guys and St Thomas NHS Foundation Trust /ID# 250467 London London, City Of United Kingdom SE1 9RT
    291 Great Ormond Street Hospital for Children /ID# 250507 London London, City Of United Kingdom WC1N 3JH
    292 The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 251762 Kings Lynn Norfolk United Kingdom PE30 4ET
    293 NHS Greater Glasgow and Clyde /ID# 250068 Glasgow Scotland United Kingdom G12 0XH
    294 Epsom & St Helier University Hospital NHS Trust /ID# 250598 Carshalton Surrey United Kingdom SM5 1AA
    295 London North West University Healthcare NHS Trust /ID# 250097 Harrow United Kingdom HA1 3UJ
    296 Whittington Health NHS Trust /ID# 250504 London United Kingdom N19 5NF
    297 Northern Care Alliance NHS Group /ID# 251236 Salford United Kingdom M6 8HD
    298 Mid Yorkshire Hospitals NHS Trust /ID# 250508 Wakefield United Kingdom WF1 4DG

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05601882
    Other Study ID Numbers:
    • M23-696
    • 2022-002482-15
    First Posted:
    Nov 1, 2022
    Last Update Posted:
    Feb 3, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2023