AzTrials
AzTrials

Atopic DermatitisPhase 3Level UpNCT05601882

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

A Phase 3 study testing Dupilumab and Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 257 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 64 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Dupilumab and Upadacitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
920 participants
Where
257 sitesin 29 countries
Study dates
28 Nov 2022to 8 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 64 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

257 sites in 29 countries.

257 sites in 29 countries

United States58 sites

  • Arlington Research Center, Inc /ID# 250468

    Arlington, Texas, 76011

  • Orion Clinical Research /ID# 250473

    Austin, Texas, 78759-4100

  • Bellaire Dermatology Associates /ID# 250739

    Bellaire, Texas, 77401

  • Derm of Greater Columbus /ID# 250049

    Bexley, Ohio, 43209-2422

  • Clearlyderm Dermatology /ID# 250457

    Boca Raton, Florida, 33428

  • Skin Care Research Boca Raton /ID# 250458

    Boca Raton, Florida, 33486-2269

  • Treasure Valley Medical Research /ID# 250727

    Boise, Idaho, 83706

  • Beth Israel Deaconess Medical Center /ID# 251212

    Boston, Massachusetts, 02215-5400

  • Duplicate_Medical University of South Carolina /ID# 251218

    Charleston, South Carolina, 29425-8903

  • University of Virginia - Dermatology /ID# 254166

    Charlottesville, Virginia, 22903

  • Clarkston Dermatology /ID# 250225

    Clarkston, Michigan, 48346

  • Olympian Clinical Research /ID# 250453

    Clearwater, Florida, 33756

  • Univ Hosp Cleveland /ID# 250699

    Cleveland, Ohio, 44106

  • Modern Research Associates, PLLC /ID# 250688

    Dallas, Texas, 75231

  • Henry Ford Medical Center - New Center One /ID# 250228

    Detroit, Michigan, 48202-3046

  • Joseph Raoof Md,Inc /Id# 250211

    Encino, California, 91436

  • Wright State Physicians - Fairborn /ID# 254167

    Fairborn, Ohio, 45324-2640

  • UConn Health /ID# 253807

    Farmington, Connecticut, 06030

  • Clinical Trials Institute - Northwest Arkansas /ID# 249838

    Fayetteville, Arkansas, 72703

  • First OC Dermatology /ID# 250686

    Fountain Valley, California, 92708

  • Skin Care Research - Hollywood /ID# 250459

    Hollywood, Florida, 33021-6748

  • Center for Clinical Studies - Houston - Northwest Freeway /ID# 250039

    Houston, Texas, 77065

  • Dawes Fretzin, LLC /ID# 250276

    Indianapolis, Indiana, 46256

  • Solutions Through Adv Rch /ID# 250455

    Jacksonville, Florida, 32256

  • Cleaver Dermatology /ID# 250725

    Kirksville, Missouri, 63501-5362

  • Antelope Valley Clinical Trials /ID# 249946

    Lancaster, California, 93534

  • Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616

    Lincoln, Nebraska, 68505-2343

  • Physician Research Collaboration, LLC /ID# 251099

    Lincoln, Nebraska, 68516

  • Dermatology Research Associates /ID# 249829

    Los Angeles, California, 90045

  • GSI Clinical Research, LLC /ID# 250768

    Margate, Florida, 33063

  • D&H National Research Centers /ID# 250734

    Miami, Florida, 33155

  • Florida International Rsrch cr /ID# 249667

    Miami, Florida, 33173

  • Wellness Clinical Research - Miami Lakes /ID# 250236

    Miami Lakes, Florida, 33016

  • International Clinical Research - Tennessee LLC /ID# 250724

    Murfreesboro, Tennessee, 37130-2450

  • University of Utah /ID# 250042

    Murray, Utah, 84107

  • Yale Center for Clinical Investigation /ID# 254791

    New Haven, Connecticut, 06519

  • Virginia Clinical Research, Inc. /ID# 249908

    Norfolk, Virginia, 23502

  • Arkansas Research Trials /ID# 250722

    North Little Rock, Arkansas, 72217

  • Tory P Sullivan, MD PA /ID# 251136

    North Miami Beach, Florida, 33162-4708

  • Medical Dermatology Specialists /ID# 250212

    Phoenix, Arizona, 85006

  • Alliance Dermatology and Mohs Center /ID# 249671

    Phoenix, Arizona, 85032

  • University of Pittsburgh MC /ID# 251208

    Pittsburgh, Pennsylvania, 15260

  • Oregon Dermatology and Research Center /ID# 250726

    Portland, Oregon, 97210

  • Oregon Medical Research Center /ID# 249666

    Portland, Oregon, 97223

  • Oregon Medical Research Center /ID# 250712

    Portland, Oregon, 97239

  • Beacon Clinical Research, LLC /ID# 251412

    Quincy, Massachusetts, 02169

  • Health Concepts /ID# 250988

    Rapid City, South Dakota, 57702

  • University of California Davis Health /ID# 250044

    Sacramento, California, 95817

  • MediSearch Clinical Trials /ID# 250272

    Saint Joseph, Missouri, 64506

  • Texas Dermatology and Laser Specialists /ID# 250367

    San Antonio, Texas, 78218-3128

  • Precision Clinical Research /ID# 250990

    Sunrise, Florida, 33351-7311

  • Advanced Clinical Research Institute /ID# 250460

    Tampa, Florida, 33607

  • Montefiore Medical Center - Moses Campus /ID# 251214

    The Bronx, New York, 10467

  • Clinical Trials Research Institute /ID# 250213

    Thousand Oaks, California, 91320-2130

  • Vital Prospects Clinical Research Institute, PC /ID# 249840

    Tulsa, Oklahoma, 74136-7049

  • Randall Dermatology of West Lafayette /ID# 250234

    West Lafayette, Indiana, 47906-1569

  • Metabolic Research Inst /ID# 250046

    West Palm Beach, Florida, 33401

  • Western States Clinical Res /ID# 250274

    Wheat Ridge, Colorado, 80033-2896

Other trials in United States

Germany19 sites

  • Fachklinik Bad Bentheim /ID# 249545

    Bad Bentheim, Saarland, 48455

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306

    Blankenfelde-Mahlow, Brandenburg, 15831

  • Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566

    Bochum, 44793

  • Universitaetsklinikum Bonn /ID# 250307

    Bonn, North Rhine-Westphalia, 53127

  • Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392

    Bramsche, Lower Saxony, 49565

  • Klinikum Darmstadt /ID# 251391

    Darmstadt, Hesse, 64283

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844

    Dresden, 01307

  • Universitaetsklinikum Frankfurt /ID# 249544

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg /ID# 249555

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Derma Study Center Friedrichshafen GmbH /ID# 251460

    Friedrichshafen, 88045

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 249547

    Hamburg, 20246

  • Dermatologikum Hamburg /ID# 251390

    Hamburg, 20354

  • Universitaetsklinik Heidelberg /ID# 251458

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Leipzig /ID# 249562

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560

    Lübeck, Schleswig-Holstein, 23538

  • Universitaetsmedizin Mainz /ID# 249549

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum rechts der Isar /ID# 249548

    Munich, 81675

  • Universitaetsklinikum Muenster /ID# 249404

    Münster, North Rhine-Westphalia, 48149

  • Universitaetsklinikum Tuebingen /ID# 249552

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Canada16 sites

  • Dermatology Research Institute - Blackfoot Trail /ID# 251642

    Calgary, Alberta, T2J 7E1

  • Beacon Dermatology Inc /ID# 250336

    Calgary, Alberta, T3A 2N1

  • Alberta DermaSurgery Centre /ID# 250217

    Edmonton, Alberta, T6G 1C3

  • Brunswick Dermatology Center /ID# 250220

    Fredericton, New Brunswick, E3B 1G9

  • LEADER Research /ID# 251647

    Hamilton, Ontario, L8L 3C3

  • DermEffects /ID# 250223

    London, Ontario, N6H 5L5

  • Lynde Institute for Dermatology /ID# 251854

    Markham, Ontario, L3P 1X2

  • DermEdge Research Inc. /ID# 250216

    Mississauga, Ontario, L4Y 4C5

  • SKiN Centre for Dermatology /ID# 251853

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427

    Québec, Quebec, G1V 4X7

  • Dr. Chih-ho Hong Medical Inc. /ID# 251643

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research /ID# 251645

    Surrey, British Columbia, V3V 0C6

  • Toronto Dermatology Centre /ID# 252098

    Toronto, Ontario, M3H 5Y8

  • Research Toronto /ID# 250222

    Toronto, Ontario, M4W 2N4

  • Private Practice - Dr. Kim Papp Clinical Research /ID# 251644

    Waterloo, Ontario, N2J 1C4

  • Wiseman Dermatology Research /ID# 250219

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

China14 sites

  • The Second Xiangya Hospital of Central South University /ID# 249657

    Changsha, Guizhou, 410011

  • The First Affiliated Hospital Of Fujian Medical University /ID# 249674

    Fuzhou, Fujian, 350005

  • Dermatology Hospital of Southern Medical University /ID# 250121

    Guangzhou, Guangdong, 510091

  • Guangzhou First People's Hospital /ID# 249695

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694

    Guangzhou, Guangdong, 510260

  • Hangzhou First People's Hospital /ID# 249437

    Hangzhou, Zhejiang, 310003

  • The second affiliated hospital of Zhejiang University school of medicine /ID# 249655

    Hangzhou, Zhejiang, 310009

  • Zhejiang Provincial People's Hospital /ID# 249653

    Hangzhou, Zhejiang, 310014

  • Huashan Hospital, Fudan University /ID# 250025

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Skin Disease Hospital /ID# 249392

    Shanghai, Shanghai Municipality, 200443

  • The First Hospital of China Medical University /ID# 249638

    Shenyang, Liaoning, 110001

  • The University of Hong Kong- Shenzhen Hospital /ID# 249436

    Shenzhen, Guangdong, 518048

  • Tianjin Medical University General Hospital /ID# 250246

    Tianjin, Tianjin Municipality, 300052

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485

    Wuhan, Hubei, 430022

Other trials in China

Poland13 sites

  • INTER CLINIC Piotr Adrian Klimiuk /ID# 251430

    Bialystok, Podlaskie Voivodeship, 15-077

  • Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082

    Cracow, Lesser Poland Voivodeship, 30-438

  • Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630

    Cracow, 30-033

  • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431

    Gdansk, Pomeranian Voivodeship, 80-546

  • Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598

    Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440

  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437

    Krakow, Lesser Poland Voivodeship, 31-011

  • Dermed Centrum Medyczne Sp. z o.o /ID# 251429

    Lodz, Łódź Voivodeship, 90-265

  • Solumed Centrum Medyczne /ID# 249641

    Poznan, Greater Poland Voivodeship, 60-529

  • MICS Centrum Medyczne Torun /ID# 251433

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Klinika Ambroziak Sp. z o.o. /ID# 249406

    Warsaw, Masovian Voivodeship, 02-953

  • Royalderm Agnieszka Nawrocka /ID# 251432

    Warsaw, Masovian Voivodeship, 02-962

  • Bodyclinic Sp. z o.o. sp.k. /ID# 249599

    Warsaw, Masovian Voivodeship, 03-712

Other trials in Poland

Italy12 sites

  • ASST degli Spedali Civili di Brescia /ID# 250129

    Brescia, 25123

  • CAST - Center for Advanced Studies and Technology /ID# 251495

    Chieti, L Aquila, 66100

  • Ospedale Piero Palagi /ID# 250206

    Florence, 50122

  • Presidio Ospedaliero San Salvatore /ID# 250127

    L’Aquila, L Aquila, 67100

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 250123

    Milan, 20122

  • Azienda Ospedaliero-Universitaria di Modena /ID# 250128

    Modena, 41124

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 251572

    Perugia, 06156

  • Azienda Ospedaliero Universitaria Pisana /ID# 250124

    Pisa, 56126

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125

    Rome, Roma, 00133

  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558

    Rome, Roma, 00144

  • Policlinico Agostino Gemelli /ID# 251494

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 251493

    Rozzano, Milano, 20089

Other trials in Italy

Hungary11 sites

  • Clinexpert Kft /ID# 249822

    Budapest, 1033

  • Semmelweis Egyetem /ID# 251368

    Budapest, 1085

  • UNO Medical Trials /ID# 249820

    Budapest, 1135

  • Debreceni Egyetem-Klinikai Kozpont /ID# 249849

    Debrecen, Hajdú-Bihar, 4032

  • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 249819

    Debrecen, 4031

  • Gyongyosi Bugat Pal Korhaz /ID# 251367

    Gyöngyös, Heves County, 3200

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848

    Kaposvár, Somogy County, 7400

  • Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 249850

    Kecskemét, Bács-Kiskun county, 6000

  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419

    Pecs, Nógrád megye, 7624

  • Szegedi Tudományegyetem /ID# 249818

    Szeged, 6720

  • Allergo-Derm Bakos Kft. /ID# 249821

    Szolnok, 5000

Other trials in Hungary

Bulgaria9 sites

  • UMHAT Dr Georgi Stranski EAD /ID# 251268

    Pleven, Smolyan, 5800

  • DCC Pulmed AD /ID# 251271

    Plovdiv, 4001

  • Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 251272

    Sofia, 1407

  • Diagnostic consultative center Focus-5 /ID# 251269

    Sofia, 1463

  • Medical Center Euroderma /ID# 251267

    Sofia, 1606

  • Medical center EuroHealth /ID# 251270

    Sofia, 1606

  • Military Medical Academy Multiprofile Hospital /ID# 251187

    Sofia, 1606

  • Diagnostic Consultative Center Aleksandrovska /ID# 251137

    Sofiya, Sofia, 1431

  • MC Zara-Med EOOD /ID# 251135

    Stara Zagora, 6000

Other trials in Bulgaria

Portugal9 sites

  • Hospital Garcia de Orta /ID# 251455

    Almada, Setúbal District, 2805-267

  • 2CA-Braga, Hospital de Braga /ID# 250480

    Braga, 4710-243

  • Centro Hospitalar Do Alto Ave - Hospital Senhora Da Oliveira /ID# 249196

    Guimarães, Braga District, 4839-008

  • Unidade Local de Saude da Regiao de Leiria, EPE /ID# 249194

    Leiria, 2410-197

  • Hospital CUF Descobertas /ID# 249193

    Lisboa, Madeira, 1998-018

  • Centro Hospitalar de Lisboa Central /ID# 249195

    Lisbon, 1169-050

  • Unidade Local de Saúde de Matosinhos, EPE /ID# 249197

    Matosinhos Municipality, 4464-513

  • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191

    Porto, Madeira, 4099-001

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192

    Porto, 4200-319

Other trials in Portugal

Taiwan9 sites

  • National Taiwan University Hospital - Hsinchu branch /ID# 249265

    Hsinchu, 30059

  • Kaohsiung Chang Gung Memorial Hospital /ID# 249260

    Kaohsiung City, Kaohsiung, 833

  • Taipei Medical University Shuang Ho Hospital /ID# 249256

    New Taipei City, 23561

  • Taichung Veterans General Hospital /ID# 249261

    Taichung, Keelung, 40705

  • Mackay Memorial Hospital /ID# 249259

    Taipei, 104

  • Taipei Veterans General Hosp /ID# 249263

    Taipei, 11217

  • Taipei Municipal Wan Fang Hospital /ID# 251500

    Taipei, 116

  • National Taiwan University Hospital /ID# 249258

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 249257

    Taoyuan City, 333

Other trials in Taiwan

South Korea8 sites

  • Korea University Ansan Hospital /ID# 249814

    Ansan-si, Gyeonggido, 15355

  • Soon Chun Hyang University Hospital Bucheon /ID# 249812

    Bucheon-si, Gyeonggido, 14584

  • Pusan National University Hospital /ID# 249852

    Busan, Busan Gwang Yeogsi, 49241

  • Chungang University Hospital /ID# 251490

    Dongjak-gu, Gyeonggido, 06973

  • Kyungpook National University Hospital /ID# 249855

    Junggu, Daegu Gwang Yeogsi, 41944

  • Seoul National University Hospital /ID# 251492

    Seoul, Seoul Teugbyeolsi, 03080

  • Konkuk University Medical Center /ID# 249811

    Seoul, Seoul Teugbyeolsi, 05030

  • Ajou University Hospital /ID# 251491

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Spain8 sites

  • Hospital General Universitario de Alicante Doctor Balmis /ID# 251517

    Alicante, 03010

  • Hospital Universitario Germans Trias i Pujol /ID# 251523

    Badalona, Barcelona, 08916

  • Hospital Universitario Basurto /ID# 249784

    Bilbao, Vizcaya, 48013

  • Hospital Sant Joan de Deu /ID# 249602

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitario Virgen de las Nieves /ID# 249785

    Granada, 18014

  • Hospital Universitario La Paz /ID# 251518

    Madrid, 28046

  • Hospital Universitario Virgen Macarena /ID# 249603

    Seville, 41009

  • Hospital Universitario y Politecnico La Fe /ID# 251524

    Valencia, 46026

Other trials in Spain

Croatia7 sites

  • Poliklinika Solmed /ID# 252138

    Grad Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Rijeka /ID# 249593

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar (KBC) Split /ID# 249879

    Split, Split-Dalmatia County, 21000

  • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591

    Zagreb, City of Zagreb, 10000

  • Djecja bolnica Srebrnjak /ID# 249594

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 249596

    Zagreb, City of Zagreb, 10000

  • Klinika za dječje bolesti Zagreb /ID# 249590

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Japan7 sites

  • Osaka Habikino Medical Center /ID# 252550

    Habikino-shi, Osaka, 583-8588

  • Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554

    Kawasaki-shi, Kanagawa, 211-0063

  • National Hospital Organization Sagamihara National Hospital /ID# 254518

    Sagamihara-shi, Kanagawa, 252-0392

  • Dermatology and Ophthalmology Kume Clinic /ID# 254570

    Sakai-shi, Osaka, 5938324

  • Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549

    Sapporo, Hokkaido, 060-0063

  • Naoko Dermatology Clinic /ID# 254571

    Setagaya-ku, Tokyo, 158-0097

  • Queen's Square Medical Center, Dermatology and Allergology /ID# 252551

    Yokohama, Kanagawa, 220-6208

Other trials in Japan

France6 sites

  • Hopital Saint Joseph /ID# 251053

    Marseille, Bouches-du-Rhone, 13008

  • CHU de Nantes, Hotel Dieu -HME /ID# 251347

    Nantes, Pays de la Loire Region, 44000

  • Hôpital Saint-Louis /ID# 251052

    Paris, 75010

  • HCL - Hopital Lyon Sud /ID# 251343

    Pierre-Bénite, Rhone, 69495

  • Hôpital Charles-Nicolle /ID# 251055

    Rouen, 76000

  • CHU Toulouse - Hopital Larrey /ID# 251344

    Toulouse, 31400

Other trials in France

Turkey (Türkiye)6 sites

  • Ankara City Hospital /ID# 249870

    Ankara, 06800

  • Akdeniz Universitesi Tip Fakul /ID# 249866

    Antalya, 07059

  • Uludag University Medical Faculty /ID# 249864

    Bursa, 16059

  • Gaziantep Universitesi /ID# 249868

    Gaziantep, Adana, 27310

  • Erciyes University Medical Faculty /ID# 249863

    Kayseri, 38039

  • Ondokuz Mayis Universitesi /ID# 249865

    Samsun, 55139

Other trials in Turkey (Türkiye)

Australia5 sites

  • Skin Health Institute Inc /ID# 249938

    Carlton, Victoria, 3053

  • Sinclair Dermatology - Melbourne /ID# 249937

    East Melbourne, Victoria, 3002

  • Fremantle Dermatology /ID# 249941

    Fremantle, Western Australia, 6160

  • Premier Specialist /ID# 250572

    Kogarah, New South Wales, 2217

  • Veracity Clinical Research /ID# 249943

    Woolloongabba, Queensland, 4102

Other trials in Australia

Mexico5 sites

  • Cryptex Investigacion Clinica S.A de C.V /ID# 249994

    Mexico City, 06100

  • Centro de Dermatologia de Monterrey /ID# 249126

    Monterrey, Estado de Baja California, 64640

  • Eukarya PharmaSite, SC /ID# 249702

    Monterrey, Nuevo León, 64718

  • Clinical Research Institute SC /ID# 249647

    Tlalnepantla, 54055

  • Arké Estudios Clinicos Veracruz /ID# 250147

    Veracruz, 91910

Other trials in Mexico

South Africa5 sites

  • Allergy & Immunology (AIU) /ID# 249619

    Cape Town, Western Cape, 7700

  • Spoke Research Inc /ID# 250091

    CAPE TOWN Milnerton, Western Cape, 7441

  • Highway Medical Centre /ID# 250103

    Durban, KwaZulu-Natal, 3630

  • University of Pretoria /ID# 250208

    Pretoria, Gauteng, 0001

  • About Allergy /ID# 249697

    Pretoria, Gauteng, 0181

Other trials in South Africa

Belgium4 sites

  • Grand Hopital de Charleroi /ID# 251401

    Charleroi, Hainaut, 6000

  • Universitair Ziekenhuis Leuven /ID# 251399

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 251400

    Liège, 4000

  • Cliniques Universitaires UCL Saint-Luc /ID# 251403

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Denmark4 sites

  • Aarhus Universitetshospital - Skejby /ID# 248899

    Aarhus, Central Jutland, 8200

  • Bispebjerg and Frederiksberg Hospital /ID# 248902

    Copenhagen NV, Capital Region, 2400

  • Herlev and Gentofte Hospital /ID# 248900

    Hellerup, Capital Region, 2900

  • Roskilde Sygehus /ID# 248901

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Puerto Rico4 sites

  • Dr. Samuel Sanchez PSC /ID# 250389

    Caguas, 00727

  • Alma M. Cruz Santana, MD-Private practice /ID# 250393

    Carolina, 00985

  • Clinical Research Puerto Rico /ID# 250394

    San Juan, 00909-1711

  • GCM Medical Group PSC /ID# 250391

    San Juan, 00917-3104

Other trials in Puerto Rico

Sweden4 sites

  • Malarsjukhuset /ID# 251908

    Eskilstuna, 633 49

  • Skane University hospital /ID# 250332

    Malmö, Skåne County, 214 28

  • Karolinska University Hospital Solna /ID# 250328

    Solna, Stockholm County, 171 64

  • Norrlands University hospital /ID# 250329

    Umeå, Västerbotten County, 581 85

Other trials in Sweden

Greece3 sites

  • 401 GSNA - 401 Army General Hospital /ID# 251843

    Athens, Attica, 11527

  • General Hospital Andreas Syggros /ID# 251842

    Athens, Attica, 16121

  • Papageorgiou General Hospital /ID# 251840

    Thessaloniki, Evrytania, 56429

Other trials in Greece

Slovakia3 sites

  • Derma therapy spol /ID# 249783

    Bratislava, Bratislava Region, 851 01

  • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746

    Bratislava, 811 09

  • BeneDerma s.r.o. /ID# 251791

    Bratislava, 841 04

Other trials in Slovakia

Israel2 sites

  • Rabin Medical Center /ID# 251578

    Haifa, 4941492

  • Hadassah Medical Center-Hebrew University /ID# 251576

    Jerusalem, Jerusalem, 91120

Other trials in Israel

Netherlands2 sites

  • Amsterdam UMC, locatie AMC /ID# 251397

    Amsterdam, North Holland, 1105 AZ

  • Bravis Ziekenhuis /ID# 251395

    Bergen op Zoom, North Brabant, 4624 VT

Other trials in Netherlands

Romania2 sites

  • Bio Terra Med SRL /ID# 249624

    Bucharest, Bucharest, 010701

  • Private Practice - Dr. Orasan Remus /ID# 249625

    Cluj-Napoca, Cluj, 400006

Other trials in Romania

Switzerland2 sites

  • Inselspital, Universitaetsspital Bern /ID# 250577

    Bern, 3010

  • Kantonsspital St. Gallen /ID# 250606

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

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)

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. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. 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.

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.

Being tested
Dupilumab, Upadacitinib
Keywords
Atopic Dermatitis, AD, Level-Up, Upadacitinib, Dupilumab, RINVOQ
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called Dupixent®

    Dupilumab is administered as a subcutaneous (SC) injection.

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Extended-release tablet

Study groups in NCT05601882
Study groupRoleWhat they receive
Dupilumab (Period 1)ExperimentalAdult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16. Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to < 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
Receives: Drug: Dupilumab
Upadacitinib (Period 1)ExperimentalParticipants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response.
Receives: Drug: Upadacitinib
Dupilumab -> Upadacitinib (Period 2)ExperimentalAt Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with < EASI 75 or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.
Receives: Drug: Upadacitinib
Upadacitinib -> Upadacitinib 30 mg (Period 2)ExperimentalAt Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.
Receives: Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16

    The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline and Week 16

Secondary outcomes (8)

  1. Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16

    The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

    Measured: Baseline and Week 16

  2. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline and Week 16

  3. Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline and Week 16

  4. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline and Week 4

  5. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline and Week 2

  6. Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4

    The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

    Measured: Baseline and Week 4

  7. Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2

    The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

    Measured: Baseline and Week 2

  8. Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16

    The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2022
  2. Study start28 Nov 2022
  3. Primary completion19 Mar 2024
  4. Study completion8 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05601882
Sponsor's protocol ID
M23-696
Other IDs
2022-002482-15
Acronym
Level Up
Status last verified
Jan 2025
First submitted
31 Oct 2022
Last updated
14 Feb 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bunick CG, Magnolo N, Moore A, Abe M, Gao X, Lynde C, Ibrahim N, Levy G, Calimlim BM, Wu X, Armendariz Y, Grada A, Eyerich K. Switching from Dupilumab to Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis After Inadequate Response to Dupilumab: Efficacy and Safety Results from Period 2 of Phase 3b/4 Study (LEVEL UP). Am J Clin Dermatol. 2026 Mar;27(2):391-399. doi: 10.1007/s40257-025-01003-0. Epub 2026 Jan 14.

    PubMed 41533220

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab and Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 257 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 257 sites in United States, Germany, Canada, China, Poland and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05601882, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

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