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)
Atopic Dermatitis
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
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
Experimental
Experimental
Upadacitinib
Dupilumab followed by Upadacitinib
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.