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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 (Level Up)

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Dupilumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, AD, Level-Up, Upadacitinib, Dupilumab, RINVOQ

Eligibility Criteria

12 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Dermatology Specialist /ID# 250212Recruiting
  • Alliance Dermatology and MOHs Center, PC /ID# 249671Recruiting
  • Clinical Trials Institute at Northwest Arkansas /ID# 249838Recruiting
  • Arkansas Research Trials, LLC /ID# 250722Recruiting
  • T. Joseph Raoof Md,Inc /Id# 250211Recruiting
  • First OC Dermatology Research /ID# 250686Recruiting
  • Antelope Valley Clinical Trials /ID# 249946
  • Dermatology Research Associates /ID# 249829Recruiting
  • UC Davis Health /ID# 250044Recruiting
  • Clinical Trials Research Institute /ID# 250213Recruiting
  • Western States Clinical Res /ID# 250274Recruiting
  • UConn Health /ID# 253807Recruiting
  • Clearlyderm Dermatology /ID# 250457Recruiting
  • Skin Care Research - Boca Raton /ID# 250458Recruiting
  • Olympian Clinical Research /ID# 250453Recruiting
  • Skin Care Research - Hollywood /ID# 250459Recruiting
  • Solutions Through Adv Rch /ID# 250455Recruiting
  • GSI Clinical Research, LLC /ID# 250768Recruiting
  • Wellness Clinical Research /ID# 250236Recruiting
  • D&H National Research Centers /ID# 250734Recruiting
  • Florida International Rsrch cr /ID# 249667
  • Tory P Sullivan, MD PA /ID# 251136Recruiting
  • Precision Clinical Research /ID# 250990Recruiting
  • Advanced Clinical Research Institute /ID# 250460Recruiting
  • Metabolic Research Inst /ID# 250046Recruiting
  • Treasure Valley Medical Research /ID# 250727Recruiting
  • Dawes Fretzin, LLC /ID# 250276Recruiting
  • Randall Dermatology of West Lafayette /ID# 250234Recruiting
  • Beth Israel Deaconess Medical Center /ID# 251212Recruiting
  • Beacon Clinical Research, LLC /ID# 251412Recruiting
  • Michigan Center for Research Company /ID# 250225Recruiting
  • Henry Ford Medical Center /ID# 250228Recruiting
  • Cleaver Dermatology /ID# 250725Recruiting
  • MediSearch Clinical Trials /ID# 250272Recruiting
  • Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616
  • Physician Research Collaboration, LLC /ID# 251099Recruiting
  • Montefiore Medical Center - Moses Campus /ID# 251214Recruiting
  • Derm of Greater Columbus /ID# 250049Recruiting
  • Univ Hosp Cleveland /ID# 250699Recruiting
  • Wright State Physicians - Fairborn /ID# 254167Recruiting
  • Vital Prospects Clinical Research Institute, PC /ID# 249840Recruiting
  • Oregon Dermatology and Research Center /ID# 250726Recruiting
  • Oregon Medical Res Center PC /ID# 249666Recruiting
  • Oregon Medical Research Center /ID# 250712Recruiting
  • University of Pittsburgh MC /ID# 251208Recruiting
  • MUSC - Rutledge Tower /ID# 251218Recruiting
  • Health Concepts /ID# 250988Recruiting
  • International Clinical Research - Tennessee LLC /ID# 250724Recruiting
  • Arlington Research Center, Inc /ID# 250468Recruiting
  • Orion Clinical Research /ID# 250473Recruiting
  • Bellaire Dermatology Associates /ID# 250739Recruiting
  • Modern Research Associates, PLLC /ID# 250688Recruiting
  • Center for Clinical Studies /ID# 250039Recruiting
  • Texas Dermatology and Laser Specialists /ID# 250367Recruiting
  • University of Utah Mid Valley Dermatology /ID# 250042Recruiting
  • University of Virginia - Dermatology /ID# 254166Recruiting
  • Virginia Clinical Research, Inc. /ID# 249908Recruiting
  • Premier Specialist /ID# 250572Recruiting
  • Veracity Clinical Research /ID# 249943Recruiting
  • Skin Health Institute Inc /ID# 249938Recruiting
  • Sinclair Dermatology /ID# 249937Recruiting
  • Fremantle Dermatology /ID# 249941Recruiting
  • UCL Saint-Luc /ID# 251403Recruiting
  • Grand Hopital de Charleroi /ID# 251401Recruiting
  • Universitair Ziekenhuis Leuven /ID# 251399Recruiting
  • CHU de Liege /ID# 251400Recruiting
  • UMHAT Dr Georgi Stranski EAD /ID# 251268Recruiting
  • DCC Pulmed AD /ID# 251271Recruiting
  • ASMC-IPSMC-Skin and Venereal Diseases /ID# 251272Recruiting
  • Diagnostic consultative center Aleksandrovska /ID# 251137Recruiting
  • Diagnostic consultative center Focus-5 /ID# 251269Recruiting
  • Medical center EuroHealth /ID# 251270Recruiting
  • Military Medical Academy Multiprofile Hospital /ID# 251187Recruiting
  • Medical Center Euroderma /ID# 251267Recruiting
  • MC Zara-Med EOOD /ID# 251135Recruiting
  • Dermatology Research Institute Inc. /ID# 251642Recruiting
  • Beacon Dermatology Inc /ID# 250336Recruiting
  • Alberta DermaSurgery Centre /ID# 250217Recruiting
  • Dr. Chih-ho Hong Medical Inc. /ID# 251643Recruiting
  • Enverus Medical Research /ID# 251645Recruiting
  • Wiseman Dermatology Research /ID# 250219Recruiting
  • Brunswick Dermatology Center /ID# 250220Recruiting
  • LEADER Research /ID# 251647Recruiting
  • DermEffects /ID# 250223Recruiting
  • Lynderm Research Inc. /ID# 251854Recruiting
  • DermEdge Research Inc. /ID# 250216Recruiting
  • SKIN Centre for Dermatology /ID# 251853Recruiting
  • Toronto Research Centre /ID# 252098Recruiting
  • Research Toronto /ID# 250222Recruiting
  • K. Papp Clinical Research /ID# 251644Recruiting
  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427Recruiting
  • Guangzhou First People's Hospital /ID# 249695Recruiting
  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694Recruiting
  • The University of Hong Kong- Shenzhen Hospital /ID# 249436Recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485Recruiting
  • The First Hospital of China Medical University /ID# 249638Recruiting
  • Huashan Hospital, Fudan University /ID# 250025Recruiting
  • Shanghai Skin Disease Hospital /ID# 249392Recruiting
  • Tianjin Medical University General Hospital /ID# 250246Recruiting
  • Hangzhou First People's Hospital /ID# 249437Recruiting
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 249655Recruiting
  • Zhejiang Provincial People's Hospital /ID# 249653Recruiting
  • The Second Xiangya Hospital of Central South University /ID# 249657Recruiting
  • The First Affiliated Hospital of Fujian Medical University /ID# 249674Recruiting
  • Dermatology Hospital of Southern Medical University /ID# 250121Recruiting
  • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591Recruiting
  • Djecja bolnica Srebrnjak /ID# 249594Recruiting
  • Klinicki bolnicki centar Zagreb /ID# 249596Recruiting
  • Klinika za djecje bolesti Zagreb /ID# 249590Recruiting
  • Klinicki bolnicki centar Rijeka /ID# 249593Recruiting
  • Klinicki bolnicki centar Split /ID# 249879Recruiting
  • Poliklinika Solmed /ID# 252138Recruiting
  • Bispebjerg and Frederiksberg Hospital /ID# 248902Recruiting
  • Herlev and Gentofte Hospital /ID# 248900Recruiting
  • Aarhus University Hospital /ID# 248899Recruiting
  • Sjællands Universitetshospital /ID# 248901Recruiting
  • HCL - Hopital Lyon Sud /ID# 251343Recruiting
  • Hopital Saint Joseph /ID# 251053Recruiting
  • CHU de Nantes, Hotel Dieu -HME /ID# 251347Recruiting
  • AP-HP - Hopital Saint-Louis /ID# 251052Recruiting
  • Hôpital Charles-Nicolle /ID# 251055Recruiting
  • CHU Toulouse - Hopital Larrey /ID# 251344Recruiting
  • Universitaetsklinikum Freiburg /ID# 249555Recruiting
  • Universitaetsklinik Heidelberg /ID# 251458Recruiting
  • Universitaetsklinikum Tuebingen /ID# 249552Recruiting
  • Universitaetsklinikum Frankfurt /ID# 249544Recruiting
  • Universitaetsklinikum Muenster /ID# 249404Recruiting
  • Universitaetsklinikum Leipzig /ID# 249562Recruiting
  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560Recruiting
  • Fachklinik Bad Bentheim /ID# 249545Recruiting
  • Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566Recruiting
  • Universitaetsklinikum Bonn /ID# 250307Recruiting
  • Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392Recruiting
  • Klinikum Darmstadt /ID# 251391Recruiting
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844Recruiting
  • Derma Study Center Friedrichshafen GmbH /ID# 251460Recruiting
  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 249547Recruiting
  • Dermatologikum Hamburg GmbH /ID# 251390Recruiting
  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306Recruiting
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 249549Recruiting
  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 249548Recruiting
  • 401 GSNA - 401 Army General Hospital /ID# 251843Recruiting
  • General Hospital Andreas Syggros /ID# 251842Recruiting
  • Papageorgiou General Hospital Thessaloniki /ID# 251840Recruiting
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 249818Recruiting
  • Debreceni Egyetem Klinikai Kozpont /ID# 249849Recruiting
  • Gyongyosi Bugat Pal Korhaz /ID# 251367Recruiting
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848Recruiting
  • Clinexpert Kft /ID# 249822Recruiting
  • Semmelweis Egyetem /ID# 251368Recruiting
  • Uno Medical Trials Kft /ID# 249820Recruiting
  • Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 249819Recruiting
  • Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 249850Recruiting
  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419Recruiting
  • Allergo-Derm Bakos Kft. /ID# 249821Recruiting
  • Hadassah Medical Center-Hebrew University /ID# 251576Recruiting
  • Rabin Medical Center /ID# 251578Recruiting
  • Istituto Clinico Humanitas /ID# 251493Recruiting
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125Recruiting
  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558Recruiting
  • Azienda Ospedaliera di Perugia /ID# 251572Recruiting
  • ASST Spedali civili di Brescia /ID# 250129Recruiting
  • CAST - Center for Advanced Studies and Technology /ID# 251495Recruiting
  • Ospedale Piero Palagi /ID# 250206Recruiting
  • Presidio Ospedaliero San Salvatore /ID# 250127Recruiting
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 250123Recruiting
  • Azienda Ospedaliero-Universitaria di Modena /ID# 250128Recruiting
  • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 250124Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli /ID# 251494Recruiting
  • Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549Recruiting
  • Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554Recruiting
  • National Hospital Organization Sagamihara National Hospital /ID# 254518Recruiting
  • Queen's Square Medical Center, Dermatology and Allergology /ID# 252551Recruiting
  • Osaka Habikino Medical Center /ID# 252550Recruiting
  • Dermatology and Ophthalmology Kume Clinic /ID# 254570Recruiting
  • Naoko Dermatology Clinic /ID# 254571Recruiting
  • Korea University Ansan Hospital /ID# 249814Recruiting
  • Soonchunhyang University Hospital Bucheon /ID# 249812Recruiting
  • Ajou University Hospital /ID# 251491Recruiting
  • KonKuk University Medical Center /ID# 249811Recruiting
  • Pusan National University Hospital /ID# 249852Recruiting
  • Kyungpook National University Hospital /ID# 249855Recruiting
  • Seoul National University Hospital /ID# 251492Recruiting
  • Chung-Ang University Hostipal /ID# 251490Recruiting
  • Eukarya PharmaSite, SC /ID# 249702Recruiting
  • Cryptex Investigación Clínica S.A de C.V /ID# 249994Recruiting
  • Centro de Dermatologia de Monterrey /ID# 249126Recruiting
  • Clinical Research Institute SC /ID# 249647Recruiting
  • Arke SMO, S.A. de C.V. / Veracruz /ID# 250147Recruiting
  • Bravis Ziekenhuis /ID# 251395Recruiting
  • Academisch Medisch Centrum /ID# 251397Recruiting
  • MICS Centrum Medyczne Torun /ID# 251433Recruiting
  • Dermed Centrum Medyczne Sp. z o.o /ID# 251429Recruiting
  • Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082Recruiting
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437Recruiting
  • Klinika Ambroziak Sp. z o.o. /ID# 249406Recruiting
  • Royalderm Agnieszka Nawrocka /ID# 251432Recruiting
  • Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598Recruiting
  • INTER CLINIC Piotr Adrian Klimiuk /ID# 251430Recruiting
  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431Recruiting
  • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438Recruiting
  • Solumed Centrum Medyczne /ID# 249641Recruiting
  • Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630Recruiting
  • Bodyclinic Sp. z o.o. sp.k. /ID# 249599Recruiting
  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249196Recruiting
  • Hospital Garcia de Orta, EPE /ID# 251455Recruiting
  • CCA Braga - Hospital de Braga /ID# 250480Recruiting
  • Centro Hospitalar de Leiria, EPE /ID# 249194Recruiting
  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 249195Recruiting
  • Hospital CUF Descobertas /ID# 249193Recruiting
  • Unidade Local de Saúde de Matosinhos, EPE /ID# 249197Recruiting
  • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191Recruiting
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192Recruiting
  • Dr. Samuel Sanchez PSC /ID# 250389Recruiting
  • Alma M. Cruz Santana, MD-Private practice /ID# 250393Recruiting
  • Clinical Research Puerto Rico /ID# 250394Recruiting
  • GCM Medical Group PSC /ID# 250391Recruiting
  • Bio Terra Med SRL /ID# 249624Recruiting
  • Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 249625Recruiting
  • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746Recruiting
  • Derma therapy, spol. s r.o. /ID# 249783Recruiting
  • BeneDerma s.r.o. /ID# 251791Recruiting
  • University of Pretoria /ID# 250208Recruiting
  • About Allergy /ID# 249697Recruiting
  • Dr Ahmed Ismail Manjra /ID# 250103Recruiting
  • Spoke Research Inc /ID# 250091Recruiting
  • Allergy & Immunology (AIU) /ID# 249619Recruiting
  • Hospital Universitario Germans Trias i Pujol /ID# 251523Recruiting
  • Hospital Sant Joan de Deu /ID# 249602Recruiting
  • Hospital Universitario Basurto /ID# 249784Recruiting
  • Hospital General Universitario de Alicante Doctor Balmis /ID# 251517Recruiting
  • Hospital Universitario Virgen de las Nieves /ID# 249785Recruiting
  • Hospital Universitario La Paz /ID# 251518Recruiting
  • Hospital Universitario Virgen Macarena /ID# 249603Recruiting
  • Hospital Universitario y Politecnico La Fe /ID# 251524Recruiting
  • Skane University hospital /ID# 250332Recruiting
  • Norrlands University hospital /ID# 250329Recruiting
  • Malarsjukhuset /ID# 251908Recruiting
  • Karolinska University Hospital /ID# 250328Recruiting
  • Kantonsspital St. Gallen /ID# 250606Recruiting
  • Inselspital, Universitätsspital Bern /ID# 250577Recruiting
  • Kaohsiung Chang Gung Memorial Hospital /ID# 249260Recruiting
  • National Taiwan University Hospital - Hsinchu branch /ID# 249265Recruiting
  • Taipei Medical University Shuang Ho Hospital /ID# 249256Recruiting
  • Taichung Veterans General Hospital /ID# 249261Recruiting
  • National Taiwan University Hospital /ID# 249258Recruiting
  • MacKay Memorial Hospital /ID# 249259Recruiting
  • Taipei Veterans General Hosp /ID# 249263Recruiting
  • Taipei Municipal Wan Fang Hospital /ID# 251500Recruiting
  • Linkou Chang Gung Memorial Hospital /ID# 249257Recruiting
  • Erciyes University Medical Fac /ID# 249863Recruiting
  • Ankara City Hospital /ID# 249870Recruiting
  • Akdeniz Universitesi Tip Fakul /ID# 249866Recruiting
  • Uludag University Medical Faculty /ID# 249864Recruiting
  • Gaziantep University Şahinbey Research and Practice Hospital /ID# 249868Recruiting
  • Ondokuz Mayis Universitesi Tip /ID# 249865Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upadacitinib

Dupilumab followed by Upadacitinib

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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

Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)
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.
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
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'.
Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 among those with Baseline WP-NRS ≥ 4
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'.
Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75)
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.
Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100)
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.

Full Information

First Posted
October 31, 2022
Last Updated
October 23, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05601882
Brief Title
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
Acronym
Level Up
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
April 5, 2024 (Anticipated)
Study Completion Date
August 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, AD, Level-Up, Upadacitinib, Dupilumab, RINVOQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upadacitinib
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.
Arm Title
Dupilumab followed by Upadacitinib
Arm Type
Experimental
Arm Description
Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
RINVOQ
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
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)
Description
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'.
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)
Description
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.
Time Frame
Up to week 16
Title
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
Description
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'.
Time Frame
Up to week 16
Title
Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 among those with Baseline WP-NRS ≥ 4
Description
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'.
Time Frame
At week 16
Title
Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75)
Description
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.
Time Frame
At week 2
Title
Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100)
Description
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.
Time Frame
At week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Medical Dermatology Specialist /ID# 250212
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2722
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
602-354-5770
Facility Name
Alliance Dermatology and MOHs Center, PC /ID# 249671
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Institute at Northwest Arkansas /ID# 249838
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703-6245
Country
United States
Individual Site Status
Recruiting
Facility Name
Arkansas Research Trials, LLC /ID# 250722
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
501-621-1100
Facility Name
T. Joseph Raoof Md,Inc /Id# 250211
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
First OC Dermatology Research /ID# 250686
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-3701
Country
United States
Individual Site Status
Recruiting
Facility Name
Antelope Valley Clinical Trials /ID# 249946
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Completed
Facility Name
Dermatology Research Associates /ID# 249829
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Davis Health /ID# 250044
City
Sacramento
State/Province
California
ZIP/Postal Code
95816-3300
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Research Institute /ID# 250213
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320-2130
Country
United States
Individual Site Status
Recruiting
Facility Name
Western States Clinical Res /ID# 250274
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033-2896
Country
United States
Individual Site Status
Recruiting
Facility Name
UConn Health /ID# 253807
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
860-679-3475
Facility Name
Clearlyderm Dermatology /ID# 250457
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research - Boca Raton /ID# 250458
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486-2269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-561-948-3116
Facility Name
Olympian Clinical Research /ID# 250453
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research - Hollywood /ID# 250459
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-6748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
561-948-3116
Facility Name
Solutions Through Adv Rch /ID# 250455
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-904-619-8157
Facility Name
GSI Clinical Research, LLC /ID# 250768
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellness Clinical Research /ID# 250236
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H National Research Centers /ID# 250734
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-3244
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida International Rsrch cr /ID# 249667
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Completed
Facility Name
Tory P Sullivan, MD PA /ID# 251136
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162-4708
Country
United States
Individual Site Status
Recruiting
Facility Name
Precision Clinical Research /ID# 250990
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351-7311
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research Institute /ID# 250460
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-813-879-7546
Facility Name
Metabolic Research Inst /ID# 250046
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
5618023060
Facility Name
Treasure Valley Medical Research /ID# 250727
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin, LLC /ID# 250276
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Name
Randall Dermatology of West Lafayette /ID# 250234
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906-1569
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
1800-774-1534
Facility Name
Beth Israel Deaconess Medical Center /ID# 251212
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Individual Site Status
Recruiting
Facility Name
Beacon Clinical Research, LLC /ID# 251412
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
7744626610
Facility Name
Michigan Center for Research Company /ID# 250225
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center /ID# 250228
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-3046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
3139168847
Facility Name
Cleaver Dermatology /ID# 250725
City
Kirksville
State/Province
Missouri
ZIP/Postal Code
63501-5362
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSearch Clinical Trials /ID# 250272
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Name
Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505-2343
Country
United States
Individual Site Status
Completed
Facility Name
Physician Research Collaboration, LLC /ID# 251099
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center - Moses Campus /ID# 251214
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Derm of Greater Columbus /ID# 250049
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209-2422
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ Hosp Cleveland /ID# 250699
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
216-844-5197
Facility Name
Wright State Physicians - Fairborn /ID# 254167
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324-2640
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Prospects Clinical Research Institute, PC /ID# 249840
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-7049
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Dermatology and Research Center /ID# 250726
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Medical Res Center PC /ID# 249666
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Medical Research Center /ID# 250712
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh MC /ID# 251208
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Name
MUSC - Rutledge Tower /ID# 251218
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
843-876-2281
Facility Name
Health Concepts /ID# 250988
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Recruiting
Facility Name
International Clinical Research - Tennessee LLC /ID# 250724
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130-2450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
615-410-3460
Facility Name
Arlington Research Center, Inc /ID# 250468
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Name
Orion Clinical Research /ID# 250473
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-4100
Country
United States
Individual Site Status
Recruiting
Facility Name
Bellaire Dermatology Associates /ID# 250739
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Modern Research Associates, PLLC /ID# 250688
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies /ID# 250039
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
2813433300
Facility Name
Texas Dermatology and Laser Specialists /ID# 250367
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218-3128
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Mid Valley Dermatology /ID# 250042
City
Murray
State/Province
Utah
ZIP/Postal Code
84107-7302
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia - Dermatology /ID# 254166
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
434-924-5115
Facility Name
Virginia Clinical Research, Inc. /ID# 249908
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Specialist /ID# 250572
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Veracity Clinical Research /ID# 249943
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Skin Health Institute Inc /ID# 249938
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sinclair Dermatology /ID# 249937
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fremantle Dermatology /ID# 249941
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Individual Site Status
Recruiting
Facility Name
UCL Saint-Luc /ID# 251403
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Grand Hopital de Charleroi /ID# 251401
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven /ID# 251399
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liege /ID# 251400
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UMHAT Dr Georgi Stranski EAD /ID# 251268
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC Pulmed AD /ID# 251271
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
ASMC-IPSMC-Skin and Venereal Diseases /ID# 251272
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnostic consultative center Aleksandrovska /ID# 251137
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnostic consultative center Focus-5 /ID# 251269
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical center EuroHealth /ID# 251270
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Military Medical Academy Multiprofile Hospital /ID# 251187
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Euroderma /ID# 251267
City
Sofiya
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MC Zara-Med EOOD /ID# 251135
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute Inc. /ID# 251642
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beacon Dermatology Inc /ID# 250336
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alberta DermaSurgery Centre /ID# 250217
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dr. Chih-ho Hong Medical Inc. /ID# 251643
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Enverus Medical Research /ID# 251645
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Wiseman Dermatology Research /ID# 250219
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Brunswick Dermatology Center /ID# 250220
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEADER Research /ID# 251647
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 3C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
DermEffects /ID# 250223
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Lynderm Research Inc. /ID# 251854
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Individual Site Status
Recruiting
Facility Name
DermEdge Research Inc. /ID# 250216
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
SKIN Centre for Dermatology /ID# 251853
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Research Centre /ID# 252098
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Toronto /ID# 250222
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Individual Site Status
Recruiting
Facility Name
K. Papp Clinical Research /ID# 251644
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
418-650-0777
Facility Name
Guangzhou First People's Hospital /ID# 249695
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Name
The University of Hong Kong- Shenzhen Hospital /ID# 249436
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518048
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University /ID# 249638
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital, Fudan University /ID# 250025
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Skin Disease Hospital /ID# 249392
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital /ID# 250246
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Hangzhou First People's Hospital /ID# 249437
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 249655
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital /ID# 249653
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University /ID# 249657
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University /ID# 249674
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Dermatology Hospital of Southern Medical University /ID# 250121
City
Guangzhou
ZIP/Postal Code
510091
Country
China
Individual Site Status
Recruiting
Facility Name
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Djecja bolnica Srebrnjak /ID# 249594
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Zagreb /ID# 249596
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinika za djecje bolesti Zagreb /ID# 249590
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Rijeka /ID# 249593
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Split /ID# 249879
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Poliklinika Solmed /ID# 252138
City
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Bispebjerg and Frederiksberg Hospital /ID# 248902
City
Copenhagen NV
State/Province
Hovedstaden
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Herlev and Gentofte Hospital /ID# 248900
City
Hellerup
State/Province
Hovedstaden
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital /ID# 248899
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Sjællands Universitetshospital /ID# 248901
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
HCL - Hopital Lyon Sud /ID# 251343
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Joseph /ID# 251053
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13008
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 251347
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Saint-Louis /ID# 251052
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Charles-Nicolle /ID# 251055
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Toulouse - Hopital Larrey /ID# 251344
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Freiburg /ID# 249555
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinik Heidelberg /ID# 251458
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Tuebingen /ID# 249552
City
Tubingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Frankfurt /ID# 249544
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Muenster /ID# 249404
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig /ID# 249562
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fachklinik Bad Bentheim /ID# 249545
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Bonn /ID# 250307
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Darmstadt /ID# 251391
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Derma Study Center Friedrichshafen GmbH /ID# 251460
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 249547
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dermatologikum Hamburg GmbH /ID# 251390
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 249549
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 249548
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
401 GSNA - 401 Army General Hospital /ID# 251843
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital Andreas Syggros /ID# 251842
City
Athens
State/Province
Attiki
ZIP/Postal Code
16121
Country
Greece
Individual Site Status
Recruiting
Facility Name
Papageorgiou General Hospital Thessaloniki /ID# 251840
City
Stavroupoli (Thessalonikis)
State/Province
Thessaloniki
ZIP/Postal Code
55536
Country
Greece
Individual Site Status
Recruiting
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 249818
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 249849
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Gyongyosi Bugat Pal Korhaz /ID# 251367
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft /ID# 249822
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem /ID# 251368
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Uno Medical Trials Kft /ID# 249820
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 249819
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 249850
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Allergo-Derm Bakos Kft. /ID# 249821
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center-Hebrew University /ID# 251576
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center /ID# 251578
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas /ID# 251493
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558
City
Rome
State/Province
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Perugia /ID# 251572
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali civili di Brescia /ID# 250129
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
CAST - Center for Advanced Studies and Technology /ID# 251495
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Piero Palagi /ID# 250206
City
Florence
ZIP/Postal Code
50122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Presidio Ospedaliero San Salvatore /ID# 250127
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 250123
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria di Modena /ID# 250128
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 250124
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli /ID# 251494
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Sagamihara National Hospital /ID# 254518
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Recruiting
Facility Name
Queen's Square Medical Center, Dermatology and Allergology /ID# 252551
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Habikino Medical Center /ID# 252550
City
Habikino-shi
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dermatology and Ophthalmology Kume Clinic /ID# 254570
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
5938324
Country
Japan
Individual Site Status
Recruiting
Facility Name
Naoko Dermatology Clinic /ID# 254571
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Individual Site Status
Recruiting
Facility Name
Korea University Ansan Hospital /ID# 249814
City
Ansan
State/Province
Gyeonggido
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Soonchunhyang University Hospital Bucheon /ID# 249812
City
Bucheon
State/Province
Gyeonggido
ZIP/Postal Code
14584
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital /ID# 251491
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
KonKuk University Medical Center /ID# 249811
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital /ID# 249852
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital /ID# 249855
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 251492
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chung-Ang University Hostipal /ID# 251490
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Eukarya PharmaSite, SC /ID# 249702
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Cryptex Investigación Clínica S.A de C.V /ID# 249994
City
Mexico City
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Dermatologia de Monterrey /ID# 249126
City
Monterrey
ZIP/Postal Code
64640
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute SC /ID# 249647
City
Tlalnepantla de Baz
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Arke SMO, S.A. de C.V. / Veracruz /ID# 250147
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Bravis Ziekenhuis /ID# 251395
City
Bergen op Zoom
State/Province
Noord-Brabant
ZIP/Postal Code
4624 VT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Academisch Medisch Centrum /ID# 251397
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Torun /ID# 251433
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dermed Centrum Medyczne Sp. z o.o /ID# 251429
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Recruiting
Facility Name
Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082
City
Cracow
State/Province
Malopolskie
ZIP/Postal Code
30-438
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-011
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Ambroziak Sp. z o.o. /ID# 249406
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-953
Country
Poland
Individual Site Status
Recruiting
Facility Name
Royalderm Agnieszka Nawrocka /ID# 251432
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Name
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598
City
Iwonicz-Zdrój
State/Province
Podkarpackie
ZIP/Postal Code
38-440
Country
Poland
Individual Site Status
Recruiting
Facility Name
INTER CLINIC Piotr Adrian Klimiuk /ID# 251430
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-077
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438
City
Elblag
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Solumed Centrum Medyczne /ID# 249641
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630
City
Cracow
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Name
Bodyclinic Sp. z o.o. sp.k. /ID# 249599
City
Warszawa
ZIP/Postal Code
03-712
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249196
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Garcia de Orta, EPE /ID# 251455
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Individual Site Status
Recruiting
Facility Name
CCA Braga - Hospital de Braga /ID# 250480
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Leiria, EPE /ID# 249194
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 249195
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital CUF Descobertas /ID# 249193
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Unidade Local de Saúde de Matosinhos, EPE /ID# 249197
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Dr. Samuel Sanchez PSC /ID# 250389
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Alma M. Cruz Santana, MD-Private practice /ID# 250393
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
7877691954
Facility Name
Clinical Research Puerto Rico /ID# 250394
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
787-723-5954
Facility Name
GCM Medical Group PSC /ID# 250391
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Bio Terra Med SRL /ID# 249624
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
010701
Country
Romania
Individual Site Status
Recruiting
Facility Name
Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 249625
City
Cluj Napoca
ZIP/Postal Code
400105
Country
Romania
Individual Site Status
Recruiting
Facility Name
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746
City
Bratislava
ZIP/Postal Code
811 09
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Derma therapy, spol. s r.o. /ID# 249783
City
Bratislava
ZIP/Postal Code
831 03
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
BeneDerma s.r.o. /ID# 251791
City
Bratislava
ZIP/Postal Code
841 04
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
University of Pretoria /ID# 250208
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
About Allergy /ID# 249697
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Dr Ahmed Ismail Manjra /ID# 250103
City
Westville
State/Province
Kwazulu-Natal
ZIP/Postal Code
3629
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Spoke Research Inc /ID# 250091
City
CAPE TOWN Milnerton
State/Province
Western Cape
ZIP/Postal Code
7441
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Allergy & Immunology (AIU) /ID# 249619
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 251523
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Deu /ID# 249602
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Basurto /ID# 249784
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Alicante Doctor Balmis /ID# 251517
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de las Nieves /ID# 249785
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz /ID# 251518
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena /ID# 249603
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 251524
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skane University hospital /ID# 250332
City
Malmo
State/Province
Skane Lan
ZIP/Postal Code
214 28
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Norrlands University hospital /ID# 250329
City
Umea
State/Province
Vasterbottens Lan
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Malarsjukhuset /ID# 251908
City
Eskilstuna
ZIP/Postal Code
633 49
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital /ID# 250328
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Kantonsspital St. Gallen /ID# 250606
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Inselspital, Universitätsspital Bern /ID# 250577
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 249260
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital - Hsinchu branch /ID# 249265
City
Hsinchu City
ZIP/Postal Code
30059
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University Shuang Ho Hospital /ID# 249256
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital /ID# 249261
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital /ID# 249258
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
MacKay Memorial Hospital /ID# 249259
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hosp /ID# 249263
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Municipal Wan Fang Hospital /ID# 251500
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 249257
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Erciyes University Medical Fac /ID# 249863
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital /ID# 249870
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Akdeniz Universitesi Tip Fakul /ID# 249866
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Uludag University Medical Faculty /ID# 249864
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gaziantep University Şahinbey Research and Practice Hospital /ID# 249868
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Universitesi Tip /ID# 249865
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related info

Learn more about this trial

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

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