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

NCT05601882 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M23-6962022-002482-15
• Study Type: interventional
• Target: 920
• Locations: 29 countries
• Sites: 257

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. 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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; AD; Level-Up; Upadacitinib; Dupilumab; RINVOQ

Outcome Measures

Primary Outcomes (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).

  Baseline and Week 16

Secondary Outcomes (8)

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

  Baseline and Week 16

• 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

  Baseline and Week 16

• 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

  Baseline and Week 16

• 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

  Baseline and Week 4

• 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

  Baseline and Week 2

Study Arms (4)

Dupilumab (Period 1)

EXPERIMENTAL

Adult 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.

Drug: Dupilumab

Upadacitinib (Period 1)

EXPERIMENTAL

Participants 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.

Drug: Upadacitinib

Dupilumab -> Upadacitinib (Period 2)

EXPERIMENTAL

At 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.

Drug: Upadacitinib

Upadacitinib -> Upadacitinib 30 mg (Period 2)

EXPERIMENTAL

At 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.

Drug: Upadacitinib

Interventions

Dupilumab DRUG

Dupilumab is administered as a subcutaneous (SC) injection.

Also known as: Dupixent®

Dupilumab (Period 1)

Upadacitinib DRUG

Extended-release tablet

Also known as: ABT-494, RINVOQ

Dupilumab -> Upadacitinib (Period 2); Upadacitinib (Period 1); Upadacitinib -> Upadacitinib 30 mg (Period 2)

Eligibility Criteria

• Age: 12 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (257)

Medical Dermatology Specialists /ID# 250212

Phoenix, Arizona, 85006, United States

Location

Alliance Dermatology and Mohs Center /ID# 249671

Phoenix, Arizona, 85032, United States

Location

Clinical Trials Institute - Northwest Arkansas /ID# 249838

Fayetteville, Arkansas, 72703, United States

Location

Arkansas Research Trials /ID# 250722

North Little Rock, Arkansas, 72217, United States

Location

Joseph Raoof Md,Inc /Id# 250211

Encino, California, 91436, United States

Location

First OC Dermatology /ID# 250686

Fountain Valley, California, 92708, United States

Location

Antelope Valley Clinical Trials /ID# 249946

Lancaster, California, 93534, United States

Location

Dermatology Research Associates /ID# 249829

Los Angeles, California, 90045, United States

Location

University of California Davis Health /ID# 250044

Sacramento, California, 95817, United States

Location

Clinical Trials Research Institute /ID# 250213

Thousand Oaks, California, 91320-2130, United States

Location

Western States Clinical Res /ID# 250274

Wheat Ridge, Colorado, 80033-2896, United States

Location

UConn Health /ID# 253807

Farmington, Connecticut, 06030, United States

Location

Yale Center for Clinical Investigation /ID# 254791

New Haven, Connecticut, 06519, United States

Location

Clearlyderm Dermatology /ID# 250457

Boca Raton, Florida, 33428, United States

Location

Skin Care Research Boca Raton /ID# 250458

Boca Raton, Florida, 33486-2269, United States

Location

Olympian Clinical Research /ID# 250453

Clearwater, Florida, 33756, United States

Location

Skin Care Research - Hollywood /ID# 250459

Hollywood, Florida, 33021-6748, United States

Location

Solutions Through Adv Rch /ID# 250455

Jacksonville, Florida, 32256, United States

Location

GSI Clinical Research, LLC /ID# 250768

Margate, Florida, 33063, United States

Location

D&H National Research Centers /ID# 250734

Miami, Florida, 33155, United States

Location

Florida International Rsrch cr /ID# 249667

Miami, Florida, 33173, United States

Location

Wellness Clinical Research - Miami Lakes /ID# 250236

Miami Lakes, Florida, 33016, United States

Location

Tory P Sullivan, MD PA /ID# 251136

North Miami Beach, Florida, 33162-4708, United States

Location

Precision Clinical Research /ID# 250990

Sunrise, Florida, 33351-7311, United States

Location

Advanced Clinical Research Institute /ID# 250460

Tampa, Florida, 33607, United States

Location

Metabolic Research Inst /ID# 250046

West Palm Beach, Florida, 33401, United States

Location

Treasure Valley Medical Research /ID# 250727

Boise, Idaho, 83706, United States

Location

Dawes Fretzin, LLC /ID# 250276

Indianapolis, Indiana, 46256, United States

Location

Randall Dermatology of West Lafayette /ID# 250234

West Lafayette, Indiana, 47906-1569, United States

Location

Beth Israel Deaconess Medical Center /ID# 251212

Boston, Massachusetts, 02215-5400, United States

Location

Beacon Clinical Research, LLC /ID# 251412

Quincy, Massachusetts, 02169, United States

Location

Clarkston Dermatology /ID# 250225

Clarkston, Michigan, 48346, United States

Location

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

Detroit, Michigan, 48202-3046, United States

Location

Cleaver Dermatology /ID# 250725

Kirksville, Missouri, 63501-5362, United States

Location

MediSearch Clinical Trials /ID# 250272

Saint Joseph, Missouri, 64506, United States

Location

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

Lincoln, Nebraska, 68505-2343, United States

Location

Physician Research Collaboration, LLC /ID# 251099

Lincoln, Nebraska, 68516, United States

Location

Montefiore Medical Center - Moses Campus /ID# 251214

The Bronx, New York, 10467, United States

Location

Derm of Greater Columbus /ID# 250049

Bexley, Ohio, 43209-2422, United States

Location

Univ Hosp Cleveland /ID# 250699

Cleveland, Ohio, 44106, United States

Location

Wright State Physicians - Fairborn /ID# 254167

Fairborn, Ohio, 45324-2640, United States

Location

Vital Prospects Clinical Research Institute, PC /ID# 249840

Tulsa, Oklahoma, 74136-7049, United States

Location

Oregon Dermatology and Research Center /ID# 250726

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center /ID# 249666

Portland, Oregon, 97223, United States

Location

Oregon Medical Research Center /ID# 250712

Portland, Oregon, 97239, United States

Location

University of Pittsburgh MC /ID# 251208

Pittsburgh, Pennsylvania, 15260, United States

Location

Duplicate_Medical University of South Carolina /ID# 251218

Charleston, South Carolina, 29425-8903, United States

Location

Health Concepts /ID# 250988

Rapid City, South Dakota, 57702, United States

Location

International Clinical Research - Tennessee LLC /ID# 250724

Murfreesboro, Tennessee, 37130-2450, United States

Location

Arlington Research Center, Inc /ID# 250468

Arlington, Texas, 76011, United States

Location

Orion Clinical Research /ID# 250473

Austin, Texas, 78759-4100, United States

Location

Bellaire Dermatology Associates /ID# 250739

Bellaire, Texas, 77401, United States

Location

Modern Research Associates, PLLC /ID# 250688

Dallas, Texas, 75231, United States

Location

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

Houston, Texas, 77065, United States

Location

Texas Dermatology and Laser Specialists /ID# 250367

San Antonio, Texas, 78218-3128, United States

Location

University of Utah /ID# 250042

Murray, Utah, 84107, United States

Location

University of Virginia - Dermatology /ID# 254166

Charlottesville, Virginia, 22903, United States

Location

Virginia Clinical Research, Inc. /ID# 249908

Norfolk, Virginia, 23502, United States

Location

Premier Specialist /ID# 250572

Kogarah, New South Wales, 2217, Australia

Location

Veracity Clinical Research /ID# 249943

Woolloongabba, Queensland, 4102, Australia

Location

Skin Health Institute Inc /ID# 249938

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology - Melbourne /ID# 249937

East Melbourne, Victoria, 3002, Australia

Location

Fremantle Dermatology /ID# 249941

Fremantle, Western Australia, 6160, Australia

Location

Cliniques Universitaires UCL Saint-Luc /ID# 251403

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

Grand Hopital de Charleroi /ID# 251401

Charleroi, Hainaut, 6000, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 251399

Leuven, Vlaams-Brabant, 3000, Belgium

Location

CHU de Liege /ID# 251400

Liège, 4000, Belgium

Location

UMHAT Dr Georgi Stranski EAD /ID# 251268

Pleven, Smolyan, 5800, Bulgaria

Location

Diagnostic Consultative Center Aleksandrovska /ID# 251137

Sofiya, Sofia, 1431, Bulgaria

Location

DCC Pulmed AD /ID# 251271

Plovdiv, 4001, Bulgaria

Location

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

Sofia, 1407, Bulgaria

Location

Diagnostic consultative center Focus-5 /ID# 251269

Sofia, 1463, Bulgaria

Location

Medical Center Euroderma /ID# 251267

Sofia, 1606, Bulgaria

Location

Medical center EuroHealth /ID# 251270

Sofia, 1606, Bulgaria

Location

Military Medical Academy Multiprofile Hospital /ID# 251187

Sofia, 1606, Bulgaria

Location

MC Zara-Med EOOD /ID# 251135

Stara Zagora, 6000, Bulgaria

Location

Dermatology Research Institute - Blackfoot Trail /ID# 251642

Calgary, Alberta, T2J 7E1, Canada

Location

Beacon Dermatology Inc /ID# 250336

Calgary, Alberta, T3A 2N1, Canada

Location

Alberta DermaSurgery Centre /ID# 250217

Edmonton, Alberta, T6G 1C3, Canada

Location

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

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research /ID# 251645

Surrey, British Columbia, V3V 0C6, Canada

Location

Wiseman Dermatology Research /ID# 250219

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Brunswick Dermatology Center /ID# 250220

Fredericton, New Brunswick, E3B 1G9, Canada

Location

LEADER Research /ID# 251647

Hamilton, Ontario, L8L 3C3, Canada

Location

DermEffects /ID# 250223

London, Ontario, N6H 5L5, Canada

Location

Lynde Institute for Dermatology /ID# 251854

Markham, Ontario, L3P 1X2, Canada

Location

DermEdge Research Inc. /ID# 250216

Mississauga, Ontario, L4Y 4C5, Canada

Location

SKiN Centre for Dermatology /ID# 251853

Peterborough, Ontario, K9J 5K2, Canada

Location

Toronto Dermatology Centre /ID# 252098

Toronto, Ontario, M3H 5Y8, Canada

Location

Research Toronto /ID# 250222

Toronto, Ontario, M4W 2N4, Canada

Location

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

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427

Québec, Quebec, G1V 4X7, Canada

Location

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

Fuzhou, Fujian, 350005, China

Location

Dermatology Hospital of Southern Medical University /ID# 250121

Guangzhou, Guangdong, 510091, China

Location

Guangzhou First People's Hospital /ID# 249695

Guangzhou, Guangdong, 510180, China

Location

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

Guangzhou, Guangdong, 510260, China

Location

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

Shenzhen, Guangdong, 518048, China

Location

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

Changsha, Guizhou, 410011, China

Location

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

Wuhan, Hubei, 430022, China

Location

The First Hospital of China Medical University /ID# 249638

Shenyang, Liaoning, 110001, China

Location

Huashan Hospital, Fudan University /ID# 250025

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Skin Disease Hospital /ID# 249392

Shanghai, Shanghai Municipality, 200443, China

Location

Tianjin Medical University General Hospital /ID# 250246

Tianjin, Tianjin Municipality, 300052, China

Location

Hangzhou First People's Hospital /ID# 249437

Hangzhou, Zhejiang, 310003, China

Location

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

Hangzhou, Zhejiang, 310009, China

Location

Zhejiang Provincial People's Hospital /ID# 249653

Hangzhou, Zhejiang, 310014, China

Location

Poliklinika Solmed /ID# 252138

Grad Zagreb, City of Zagreb, 10000, Croatia

Location

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591

Zagreb, City of Zagreb, 10000, Croatia

Location

Djecja bolnica Srebrnjak /ID# 249594

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 249596

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinika za dječje bolesti Zagreb /ID# 249590

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Rijeka /ID# 249593

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location

Klinicki Bolnicki Centar (KBC) Split /ID# 249879

Split, Split-Dalmatia County, 21000, Croatia

Location

Bispebjerg and Frederiksberg Hospital /ID# 248902

Copenhagen NV, Capital Region, 2400, Denmark

Location

Herlev and Gentofte Hospital /ID# 248900

Hellerup, Capital Region, 2900, Denmark

Location

Aarhus Universitetshospital - Skejby /ID# 248899

Aarhus, Central Jutland, 8200, Denmark

Location

Roskilde Sygehus /ID# 248901

Roskilde, Region Sjælland, 4000, Denmark

Location

Hopital Saint Joseph /ID# 251053

Marseille, Bouches-du-Rhone, 13008, France

Location

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

Nantes, Pays de la Loire Region, 44000, France

Location

HCL - Hopital Lyon Sud /ID# 251343

Pierre-Bénite, Rhone, 69495, France

Location

Hôpital Saint-Louis /ID# 251052

Paris, 75010, France

Location

Hôpital Charles-Nicolle /ID# 251055

Rouen, 76000, France

Location

CHU Toulouse - Hopital Larrey /ID# 251344

Toulouse, 31400, France

Location

Universitaetsklinikum Freiburg /ID# 249555

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitaetsklinik Heidelberg /ID# 251458

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitaetsklinikum Tuebingen /ID# 249552

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

Location

Klinikum Darmstadt /ID# 251391

Darmstadt, Hesse, 64283, Germany

Location

Universitaetsklinikum Frankfurt /ID# 249544

Frankfurt am Main, Hesse, 60590, Germany

Location

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

Bramsche, Lower Saxony, 49565, Germany

Location

Universitaetsklinikum Bonn /ID# 250307

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitaetsklinikum Muenster /ID# 249404

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsmedizin Mainz /ID# 249549

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Fachklinik Bad Bentheim /ID# 249545

Bad Bentheim, Saarland, 48455, Germany

Location

Universitaetsklinikum Leipzig /ID# 249562

Leipzig, Saxony, 04103, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560

Lübeck, Schleswig-Holstein, 23538, Germany

Location

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

Bochum, 44793, Germany

Location

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

Dresden, 01307, Germany

Location

Derma Study Center Friedrichshafen GmbH /ID# 251460

Friedrichshafen, 88045, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf /ID# 249547

Hamburg, 20246, Germany

Location

Dermatologikum Hamburg /ID# 251390

Hamburg, 20354, Germany

Location

Klinikum rechts der Isar /ID# 249548

Munich, 81675, Germany

Location

401 GSNA - 401 Army General Hospital /ID# 251843

Athens, Attica, 11527, Greece

Location

General Hospital Andreas Syggros /ID# 251842

Athens, Attica, 16121, Greece

Location

Papageorgiou General Hospital /ID# 251840

Thessaloniki, Evrytania, 56429, Greece

Location

Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 249850

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Debreceni Egyetem-Klinikai Kozpont /ID# 249849

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Gyongyosi Bugat Pal Korhaz /ID# 251367

Gyöngyös, Heves County, 3200, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419

Pecs, Nógrád megye, 7624, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848

Kaposvár, Somogy County, 7400, Hungary

Location

Clinexpert Kft /ID# 249822

Budapest, 1033, Hungary

Location

Semmelweis Egyetem /ID# 251368

Budapest, 1085, Hungary

Location

UNO Medical Trials /ID# 249820

Budapest, 1135, Hungary

Location

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

Debrecen, 4031, Hungary

Location

Szegedi Tudományegyetem /ID# 249818

Szeged, 6720, Hungary

Location

Allergo-Derm Bakos Kft. /ID# 249821

Szolnok, 5000, Hungary

Location

Hadassah Medical Center-Hebrew University /ID# 251576

Jerusalem, Jerusalem, 91120, Israel

Location

Rabin Medical Center /ID# 251578

Haifa, 4941492, Israel

Location

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

Chieti, L Aquila, 66100, Italy

Location

Presidio Ospedaliero San Salvatore /ID# 250127

L’Aquila, L Aquila, 67100, Italy

Location

IRCCS Istituto Clinico Humanitas /ID# 251493

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125

Rome, Roma, 00133, Italy

Location

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

Rome, Roma, 00144, Italy

Location

Policlinico Agostino Gemelli /ID# 251494

Rome, Roma, 00168, Italy

Location

ASST degli Spedali Civili di Brescia /ID# 250129

Brescia, 25123, Italy

Location

Ospedale Piero Palagi /ID# 250206

Florence, 50122, Italy

Location

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

Milan, 20122, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 250128

Modena, 41124, Italy

Location

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

Perugia, 06156, Italy

Location

Azienda Ospedaliero Universitaria Pisana /ID# 250124

Pisa, 56126, Italy

Location

Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549

Sapporo, Hokkaido, 060-0063, Japan

Location

Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554

Kawasaki-shi, Kanagawa, 211-0063, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 254518

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

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

Yokohama, Kanagawa, 220-6208, Japan

Location

Osaka Habikino Medical Center /ID# 252550

Habikino-shi, Osaka, 583-8588, Japan

Location

Dermatology and Ophthalmology Kume Clinic /ID# 254570

Sakai-shi, Osaka, 5938324, Japan

Location

Naoko Dermatology Clinic /ID# 254571

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Centro de Dermatologia de Monterrey /ID# 249126

Monterrey, Estado de Baja California, 64640, Mexico

Location

Eukarya PharmaSite, SC /ID# 249702

Monterrey, Nuevo León, 64718, Mexico

Location

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

Mexico City, 06100, Mexico

Location

Clinical Research Institute SC /ID# 249647

Tlalnepantla, 54055, Mexico

Location

Arké Estudios Clinicos Veracruz /ID# 250147

Veracruz, 91910, Mexico

Location

Bravis Ziekenhuis /ID# 251395

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Amsterdam UMC, locatie AMC /ID# 251397

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Solumed Centrum Medyczne /ID# 249641

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

MICS Centrum Medyczne Torun /ID# 251433

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 30-438, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 31-011, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Royalderm Agnieszka Nawrocka /ID# 251432

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

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

Warsaw, Masovian Voivodeship, 03-712, Poland

Location

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

Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440, Poland

Location

INTER CLINIC Piotr Adrian Klimiuk /ID# 251430

Bialystok, Podlaskie Voivodeship, 15-077, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

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

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630

Krakow, 30-033, Poland

Location

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

Lodz, Łódź Voivodeship, 90-265, Poland

Location

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

Guimarães, Braga District, 4839-008, Portugal

Location

Hospital CUF Descobertas /ID# 249193

Lisboa, Madeira, 1998-018, Portugal

Location

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

Porto, Madeira, 4099-001, Portugal

Location

Hospital Garcia de Orta /ID# 251455

Almada, Setúbal District, 2805-267, Portugal

Location

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

Braga, 4710-243, Portugal

Location

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

Leiria, 2410-197, Portugal

Location

Centro Hospitalar de Lisboa Central /ID# 249195

Lisbon, 1169-050, Portugal

Location

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

Matosinhos Municipality, 4464-513, Portugal

Location

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

Porto, 4200-319, Portugal

Location

Dr. Samuel Sanchez PSC /ID# 250389

Caguas, 00727, Puerto Rico

Location

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

Carolina, 00985, Puerto Rico

Location

Clinical Research Puerto Rico /ID# 250394

San Juan, 00909-1711, Puerto Rico

Location

GCM Medical Group PSC /ID# 250391

San Juan, 00917-3104, Puerto Rico

Location

Bio Terra Med SRL /ID# 249624

Bucharest, București, 010701, Romania

Location

Private Practice - Dr. Orasan Remus /ID# 249625

Cluj-Napoca, Cluj, 400006, Romania

Location

Derma therapy spol /ID# 249783

Bratislava, Bratislava Region, 851 01, Slovakia

Location

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

Bratislava, 811 09, Slovakia

Location

BeneDerma s.r.o. /ID# 251791

Bratislava, 841 04, Slovakia

Location

University of Pretoria /ID# 250208

Pretoria, Gauteng, 0001, South Africa

Location

About Allergy /ID# 249697

Pretoria, Gauteng, 0181, South Africa

Location

Highway Medical Centre /ID# 250103

Durban, KwaZulu-Natal, 3630, South Africa

Location

Allergy & Immunology (AIU) /ID# 249619

Cape Town, Western Cape, 7700, South Africa

Location

Spoke Research Inc /ID# 250091

CAPE TOWN Milnerton, Western Cape, 7441, South Africa

Location

Pusan National University Hospital /ID# 249852

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Kyungpook National University Hospital /ID# 249855

Junggu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Korea University Ansan Hospital /ID# 249814

Ansan-si, Gyeonggido, 15355, South Korea

Location

Soon Chun Hyang University Hospital Bucheon /ID# 249812

Bucheon-si, Gyeonggido, 14584, South Korea

Location

Chungang University Hospital /ID# 251490

Dongjak-gu, Gyeonggido, 06973, South Korea

Location

Ajou University Hospital /ID# 251491

Suwon, Gyeonggido, 16499, South Korea

Location

Seoul National University Hospital /ID# 251492

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Konkuk University Medical Center /ID# 249811

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Hospital Universitario Germans Trias i Pujol /ID# 251523

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Joan de Deu /ID# 249602

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitario Basurto /ID# 249784

Bilbao, Vizcaya, 48013, Spain

Location

Hospital General Universitario de Alicante Doctor Balmis /ID# 251517

Alicante, 03010, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 249785

Granada, 18014, Spain

Location

Hospital Universitario La Paz /ID# 251518

Madrid, 28046, Spain

Location

Hospital Universitario Virgen Macarena /ID# 249603

Seville, 41009, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 251524

Valencia, 46026, Spain

Location

Skane University hospital /ID# 250332

Malmo, Skåne County, 214 28, Sweden

Location

Karolinska University Hospital Solna /ID# 250328

Solna, Stockholm County, 171 64, Sweden

Location

Norrlands University hospital /ID# 250329

Umeå, Västerbotten County, 581 85, Sweden

Location

Malarsjukhuset /ID# 251908

Eskilstuna, 633 49, Sweden

Location

Kantonsspital St. Gallen /ID# 250606

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Inselspital, Universitaetsspital Bern /ID# 250577

Bern, 3010, Switzerland

Location

Kaohsiung Chang Gung Memorial Hospital /ID# 249260

Kaohsiung City, Kaohsiung, 833, Taiwan

Location

Taichung Veterans General Hospital /ID# 249261

Taichung, Keelung, 40705, Taiwan

Location

National Taiwan University Hospital /ID# 249258

Taipei City, Taipei, 100, Taiwan

Location

National Taiwan University Hospital - Hsinchu branch /ID# 249265

Hsinchu, 30059, Taiwan

Location

Taipei Medical University Shuang Ho Hospital /ID# 249256

New Taipei City, 23561, Taiwan

Location

Mackay Memorial Hospital /ID# 249259

Taipei, 104, Taiwan

Location

Taipei Veterans General Hosp /ID# 249263

Taipei, 11217, Taiwan

Location

Taipei Municipal Wan Fang Hospital /ID# 251500

Taipei, 116, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 249257

Taoyuan, 333, Taiwan

Location

Gaziantep Universitesi /ID# 249868

Gaziantep, Adana, 27310, Turkey (Türkiye)

Location

Ankara City Hospital /ID# 249870

Ankara, 06800, Turkey (Türkiye)

Location

Akdeniz Universitesi Tip Fakul /ID# 249866

Antalya, 07059, Turkey (Türkiye)

Location

Uludag University Medical Faculty /ID# 249864

Bursa, 16059, Turkey (Türkiye)

Location

Erciyes University Medical Faculty /ID# 249863

Kayseri, 38039, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi /ID# 249865

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (1)

• 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 Jan 14. doi: 10.1007/s40257-025-01003-0. Online ahead of print.

  PMID: 41533220 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab; upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 1, 2022
• Study Start: November 28, 2022
• Primary Completion: March 19, 2024
• Study Completion: August 8, 2024
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/

Locations

HU (11); IL (2); NL (2); IT (12); GR (3); DK (4); ME (5); TU (6); PR (4); ZA (5); KR (8); BE (4); CR (7); TW (9); BU (9); DE (19); JP (7); SL (3); SE (4); CA (16); FR (6); PL (13); PT (9); ES (8); CH (2); RO (2); CN (14); US (58); AU (5)