A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
AD Up
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
2 other identifiers
interventional
1,533
23 countries
189
Brief Summary
The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2018
Longer than P75 for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedStudy Start
First participant enrolled
August 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2021
CompletedResults Posted
Study results publicly available
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2030
ExpectedDecember 23, 2025
September 1, 2025
2.5 years
June 14, 2018
February 7, 2022
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Baseline and Week 16
Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16
The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: * 0 - Clear: No inflammatory signs of AD; * 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; * 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; * 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; * 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
Baseline and Week 16
Secondary Outcomes (22)
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16
Baseline (last available rolling average before the first dose of study drug) and Week 16
Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
Baseline and Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4
Baseline (last available rolling average before the first dose of study drug) and Week 4
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4
Baseline and Week 4
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2
Baseline and Week 2
- +17 more secondary outcomes
Study Arms (4)
Placebo / Upadacitinib + Topical Corticosteroids
PLACEBO COMPARATORParticipants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Upadacitinib 15 mg QD + Topical Corticosteroids
EXPERIMENTALParticipants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Upadacitinib 30 mg QD + Topical Corticosteroids
EXPERIMENTALParticipants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Long-Term Extension
EXPERIMENTALParticipants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.
Interventions
Tablets taken orally once a day
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Eligibility Criteria
You may qualify if:
- Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and \< 18 years of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
- Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
- Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
- Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit
You may not qualify if:
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study
- Requirement of prohibited medications during the study
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (193)
Total Skin and Beauty Derm Ctr /ID# 200548
Birmingham, Alabama, 35205, United States
Clinical Research Center AL /ID# 201865
Birmingham, Alabama, 35209-6802, United States
ACCEL Research Sites /ID# 213364
Birmingham, Alabama, 35218, United States
Advanced Dermatology and Skin Care Centre /ID# 213550
Mobile, Alabama, 36605-3004, United States
Alliance Dermatology and MOHs Center, PC /ID#200540
Phoenix, Arizona, 85032, United States
Arizona Research Center, Inc. /ID# 200546
Phoenix, Arizona, 85053-4061, United States
Clear Dermatology & Aesthetics Center /ID# 201257
Scottsdale, Arizona, 85255-4134, United States
University of Arizona /ID# 201059
Tucson, Arizona, 85719, United States
Bakersfield Derma & Skin Cance /ID# 200892
Bakersfield, California, 93309, United States
Mosaic Dermatology /ID# 200553
Beverly Hills, California, 90211, United States
University of California Irvine /ID# 200902
Irvine, California, 92697-1385, United States
Therapeutics Clinical Research /ID# 200593
San Diego, California, 92123, United States
Stanford University /ID# 200597
Stanford, California, 94305, United States
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
Aurora, Colorado, 80045-2517, United States
Colorado Center for Dermatology, PLLC /ID# 203626
Centennial, Colorado, 80111-1724, United States
Duplicate_Western States Clinical Research, Inc. /ID# 201702
Wheat Ridge, Colorado, 80033-2896, United States
Dermatology Physicians of Connecticut /ID# 201004
Shelton, Connecticut, 06484-6211, United States
Clearlyderm Dermatology /ID# 207709
Boca Raton, Florida, 33428, United States
Skin Care Research, LLC /ID# 200812
Boca Raton, Florida, 33486-2269, United States
Clinical Research of West Florida, Inc /ID# 203643
Clearwater, Florida, 33765, United States
Florida Academic Centers Research and Education /ID# 200544
Coral Gables, Florida, 33134, United States
Tory P Sullivan, MD PA /ID# 201174
North Miami Beach, Florida, 33162-4708, United States
Park Avenue Dermatology, PA /ID# 201012
Orange Park, Florida, 32073, United States
Precision Clinical Research /ID# 208734
Sunrise, Florida, 33351-7311, United States
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
Boise, Idaho, 83713, United States
Northwestern University Feinberg School of Medicine /ID# 201646
Chicago, Illinois, 60611-2927, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
Skokie, Illinois, 60077, United States
DuPage Medical Group /ID# 202065
Wheaton, Illinois, 60189-3801, United States
Deaconess Clinic Downtown /ID# 201001
Evansville, Indiana, 47713-1227, United States
Indiana University /ID# 200515
Indianapolis, Indiana, 46202, United States
Epiphany Dermatology of Kansas LLC /ID# 203026
Overland Park, Kansas, 66210, United States
ORA, Inc. /ID# 202824
Andover, Massachusetts, 01810, United States
Tufts Medical Center /ID# 200570
Boston, Massachusetts, 02111-1552, United States
Beth Israel Deaconess Medical Center /ID# 200545
Boston, Massachusetts, 02215-5400, United States
Clin Res Inst of Michigan, LLC /ID# 208020
Chesterfield, Michigan, 48047, United States
Michigan Center for Research Company /ID# 200560
Clarkston, Michigan, 48346, United States
MediSearch Clinical Trials /ID# 201006
Saint Joseph, Missouri, 64506, United States
Skin Specialists, PC /ID# 200573
Omaha, Nebraska, 68144, United States
Dartmouth-Hitchcock Medical Center /ID# 200918
Lebanon, New Hampshire, 03756, United States
Psoriasis Treatment Center of Central New Jersey /ID# 200714
East Windsor, New Jersey, 08520, United States
Juva Skin and Laser Center /ID# 200997
New York, New York, 10022-3204, United States
J. Schwartz, MD, PLLC /ID# 202122
Troy, New York, 12180-2323, United States
Bexley Dermatology Research /ID# 200899
Bexley, Ohio, 43209-2422, United States
The Ohio State University /ID# 200542
Columbus, Ohio, 43210-1257, United States
Vital Prospects Clinical Research Institute, PC /ID# 200901
Tulsa, Oklahoma, 74136-7049, United States
Oregon Dermatology and Research Center /ID# 200601
Portland, Oregon, 97210, United States
University of Pittsburgh MC /ID# 206057
Pittsburgh, Pennsylvania, 15260, United States
Rhode Island Hospital /ID# 200566
Providence, Rhode Island, 02903, United States
AAPRI Clinical Research /ID# 221134
Warwick, Rhode Island, 02886-2876, United States
Rivergate Dermatology & Skin Care Center /ID# 201698
Goodlettsville, Tennessee, 37072-2301, United States
Stones River Dermatology /ID# 204962
Murfreesboro, Tennessee, 37129-3194, United States
Arlington Research Center, Inc /ID# 200559
Arlington, Texas, 76011, United States
Center for Clinical Studies /ID# 200582
Houston, Texas, 77004, United States
Progressive Clinical Research /ID# 201582
San Antonio, Texas, 78229, United States
Center for Clinical Studies - Webster TX /ID# 203186
Webster, Texas, 77598, United States
Advanced Clinical Research - Woseth Dermatology /ID# 213745
Salt Lake City, Utah, 84117-4209, United States
Eastern Virginia Med School /ID# 200994
Norfolk, Virginia, 23507-1627, United States
Dermatology Associates of Seattle /ID# 200717
Seattle, Washington, 98101, United States
University of Wisconsin - Madison /ID# 204933
Madison, Wisconsin, 53715-1218, United States
St George Dermatology & Skin Cancer Centre /ID# 204788
Kogarah, New South Wales, 2217, Australia
Royal North Shore Hospital /ID# 204639
St Leonards, New South Wales, 2065, Australia
Westmead Hospital /ID# 205682
Westmead, New South Wales, 2145, Australia
Veracity Clinical Research /ID# 204793
Woolloongabba, Queensland, 4102, Australia
Fremantle Dermatology /ID# 205306
Fremantle, Western Australia, 6160, Australia
Medizinische Universitaet Innsbruck /ID# 210897
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
Linz, Upper Austria, 4010, Austria
Kepler Universitaetsklinikum GmbH /ID# 201075
Linz, Upper Austria, 4021, Austria
Medizinische Universitaet Wien /ID# 201080
Vienna, Vienna, 1090, Austria
UZ Brussel /ID# 203557
Jette, Brussels Capital, 1090, Belgium
UCL Saint-Luc /ID# 202028
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
UZ Gent /ID# 202030
Ghent, Oost-Vlaanderen, 9000, Belgium
IMTR - Grand Hopital de Charleroi /ID# 202029
Loverval, 6280, Belgium
Kirk Barber Research, CA /ID# 200329
Calgary, Alberta, T2G 1B1, Canada
Dermatology Research Institute Inc. /ID# 200341
Calgary, Alberta, T2J 7E1, Canada
Alberta DermaSurgery Centre /ID# 205674
Edmonton, Alberta, T6G 1C3, Canada
Karma Clinical Trials /ID# 200339
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
Eastern Canada Cutaneous Resea /ID# 200335
Halifax, Nova Scotia, B3H 1Z2, Canada
Lynderm Research Inc. /ID# 200338
Markham, Ontario, L3P 1X2, Canada
DermEdge Research Inc. /ID# 200337
Mississauga, Ontario, L5H 1G9, Canada
The Centre for Clinical Trials /ID# 205404
Oakville, Ontario, L6J 7W5, Canada
Angela Montgomery Medicine Professional Corporation /ID# 212653
Ottawa, Ontario, K1H 7X3, Canada
SKIN Centre for Dermatology /ID# 200331
Peterborough, Ontario, K9J 5K2, Canada
The Center For Dermatology /ID# 205409
Richmond Hill, Ontario, L4B 1A5, Canada
Toronto Research Centre /ID# 205411
Toronto, Ontario, M3H 5Y8, Canada
Research Toronto /ID# 205410
Toronto, Ontario, M4W 2N4, Canada
XLR8 Medical Research /ID# 205405
Windsor, Ontario, N8W 1E6, Canada
CHU Sainte-Justine /ID# 206013
Montreal, Quebec, H3T 1C5, Canada
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
Québec, Quebec, G1V 4X7, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Chinese PLA General Hospital /ID# 206786
Beijing, Beijing Municipality, 100853, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
Guangzhou, Guangdong, 510120, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
Wuhan, Hubei, 430022, China
The First Hospital of China Medical University /ID# 209840
Shenyang, Liaoning, 110001, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
Hangzhou, Zhejiang, 310006, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
Hangzhou, Zhejiang, 310009, China
Beijing Friendship Hospital /ID# 207434
Beijing, 100032, China
Xiangya Hospital Central South University /ID# 207510
Changsha, 410008, China
Huashan Hospital of Fudan University /ID# 207437
Shanghai, 200040, China
Fakultni nemocnice Plzen /ID# 202044
Pilsen, 305 99, Czechia
Sanatorium profesora Arenbergera /ID# 202082
Prague, 110 00, Czechia
Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
Prague, 128 08, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 202045
Prague, 128 08, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 205780
Nice, Alpes-Maritimes, 06200, France
AP-HM - Hopital de la Timone /ID# 206128
Marseille, Bouches-du-Rhone, 13385, France
CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
Tours, Centre-Val de Loire, 37044, France
Hopital Saint-Andre /ID# 206129
Bordeaux, 33075, France
Polyclinique Courlancy /ID# 201537
Reims, 51100, France
Universitaetsklinik Heidelberg /ID# 202097
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinikum Frankfurt /ID# 202095
Frankfurt am Main, Hesse, 60590, Germany
Universitaetsklinikum Muenster /ID# 202094
Münster, North Rhine-Westphalia, 48149, Germany
CMS3 Company for Medical Study /ID# 205195
Selters, Rhineland-Palatinate, 56242, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Bonn /ID# 202092
Bonn, 53127, Germany
TFS Trial Form Support GmbH /ID# 202096
Hamburg, 20537, Germany
Medizinische Hochschule Hannover /ID# 202098
Hanover, 30625, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
Mainz, 55131, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
Munich, 81675, Germany
401 GSNA - 401 Army General Hospital /ID# 211963
Athens, Attica, 11525, Greece
Children's Hosp P. A. Kyriakou /ID# 217573
Athens, Attica, 11527, Greece
University General Hospital Attikon /ID# 201126
Athens, Attica, 12462, Greece
General Hospital Andreas Syggros /ID# 201123
Athens, Attica, 16121, Greece
Papageorgiou General Hospital Thessaloniki /ID# 202392
Stavroupoli (Thessalonikis), Thessaloniki, 55536, Greece
Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
Thessaloniki, 54643, Greece
Prince of Wales Hospital /ID# 205152
Hong Kong, 999077, Hong Kong
Queen Mary Hospital /ID# 205146
Hong Kong, 999077, Hong Kong
Oroshazi Korhaz /ID# 203525
Orosháza, Bekes County, 5900, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
Szeged, Csongrád megye, 6725, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 201765
Debrecen, Hajdú-Bihar, 4032, Hungary
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
Debrecen, 4031, Hungary
Allergo-Derm Bakos Kft. /ID# 205361
Szolnok, 5000, Hungary
St James Hospital /ID# 201118
Dublin, Dublin, D08 NHY1, Ireland
South Infirmary Victoria University Hospital /ID# 201079
Cork, T12 X23H, Ireland
University Hospital Waterford /ID# 201253
Waterford, X91 ER8E, Ireland
Soroka University Medical Center /ID# 206652
Beersheba, Southern District, 8443901, Israel
The Chaim Sheba Medical Center /ID# 201611
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 201608
Tel Aviv, Tel Aviv, 6423906, Israel
HaEmek Medical Center /ID# 201958
Afula, 1834111, Israel
Rabin Medical Center /ID# 201959
Petah Tikva, 4941492, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
Rome, Lazio, 00168, Italy
Istituto Clinico Humanitas /ID# 200739
Rozzano, Milano, 20089, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
Ancona, 60126, Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
Catania, 95123, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 200751
Naples, 80131, Italy
Chukyo Hospital /ID# 202311
Nagoya, Aichi-ken, 457-8510, Japan
Medical Corporation Matsuo Clinic /ID# 202312
Fukuoka, Fukuoka, 819-0373, Japan
Hiroshima University Hospital /ID# 201914
Hiroshima, Hiroshima, 734-8551, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
Sapporo, Hokkaido, 060-0063, Japan
Hiramoto skin clinic /ID# 204048
Amagasaki-shi, Hyōgo, 661-0953, Japan
National Hospital Organization Sagamihara National Hospital /ID# 201658
Sagamihara-shi, Kanagawa, 252-0392, Japan
Queens Square Medical Center dermatology allergology /ID# 203850
Yokohama, Kanagawa, 220-6208, Japan
University Hospital Kyoto Prefectural University of Medicine /ID#258604
Kyoto, Kyoto, 602-8566, Japan
Kyoto University Hospital /ID# 201654
Kyoto, Kyoto, 606-8507, Japan
Tohoku University Hospital /ID# 206322
Sendai, Miyagi, 9808574, Japan
Osaka Habikino Medical Center /ID# 204243
Habikino-shi, Osaka, 583-8588, Japan
Jichi Medical University Hospital /ID# 201913
Shimotsuke-shi, Tochigi, 329-0498, Japan
Juntendo University Hospital /ID# 202888
Bunkyo-ku, Tokyo, 113-8431, Japan
Tokai University Hachioji Hospital /ID# 201711
Hachioji-shi, Tokyo, 192-0032, Japan
Maruyama Dermatology Clinic /ID# 202350
Koto-ku, Tokyo, 136-0074, Japan
Yamate Dermatological Clinic /ID# 202130
Shinjuku-ku, Tokyo, 1690075, Japan
Erasmus Medisch Centrum /ID# 202196
Rotterdam, South Holland, 3015 GD, Netherlands
Academisch Medisch Centrum /ID# 202193
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Groningen /ID# 202195
Groningen, 9713 GZ, Netherlands
Universitair Medisch Centrum Utrecht /ID# 202194
Utrecht, 3584 CX, Netherlands
Clinical Trials NZ /ID# 205336
Hamilton, 3204, New Zealand
Haukeland University Hospital /ID# 201152
Bergen, Hordaland, 5021, Norway
Universitetssykehuset N-Norge, Harstad /ID# 201269
Harstad, Troms, 9406, Norway
Universitetssykehuset N-Norge, Tromso /ID# 201270
Tromsø, Troms, 9019, Norway
Rikshospitalet OUS HF /ID# 201271
Oslo, 0450, Norway
Dr. Samuel Sanchez PSC /ID# 202002
Caguas, 00727, Puerto Rico
Clinical Research Puerto Rico /ID# 203644
San Juan, 00909, Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 202003
San Juan, 00917-3104, Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
Banská Bystrica, 975 17, Slovakia
Univerzitna nemocnica Martin /ID# 203851
Martin, 036 01, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
Nové Zámky, 940 34, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
Prešov, 081 01, Slovakia
Hospital Universitario de Puerto Real /ID# 200875
Puerto Real, Cadiz, 11510, Spain
Hospital General Universitario Alicante /ID# 200873
Alicante, 03010, Spain
Hospital Santa Creu i Sant Pau /ID# 201325
Barcelona, 08041, Spain
Hospital Universitario de la Princesa /ID# 201517
Madrid, 28006, Spain
Hospital Universitario 12 de Octubre /ID# 201135
Madrid, 28041, Spain
Hospital Universitario La Paz /ID# 205438
Madrid, 28046, Spain
Skane University Hospital Lund /ID# 201244
Lund, Skåne County, SE 221 41, Sweden
Sahlgrenska University Hospital /ID# 201274
Gothenburg, Västra Götaland County, 413 46, Sweden
Sodersjukhuset /ID# 201242
Stockholm, 118 83, Sweden
Karolinska University Hospital /ID# 201243
Stockholm, 171 76, Sweden
Barts Health NHS Trust /ID# 201044
London, London, City of, E1 2ES, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 201193
London, London, City of, SE1 9RT, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 204642
London, London, City of, SE1 9RT, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 202052
Oxford, Oxfordshire, OX3 9DU, United Kingdom
NHS Tayside /ID# 202081
Dundee, Scotland, DD2 1UB, United Kingdom
NHS Greater Glasgow and Clyde /ID# 201374
Glasgow, Scotland, G12 0XH, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 201106
Leeds, LS9 7TF, United Kingdom
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PMID: 40900410DERIVEDBurmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
PMID: 40875187DERIVEDPaller AS, Mendes-Bastos P, Siegfried E, Eichenfield LF, Soong W, Prajapati VH, Lio P, Simpson EL, Raymundo EM, Suravaram S, Hu X, Yang Y, Huang X, Calimlim BM, Platt AM, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis: Analysis of 3 Phase 3 Randomized Clinical Trials Through 76 Weeks. JAMA Dermatol. 2024 Dec 1;160(12):1304-1313. doi: 10.1001/jamadermatol.2024.3696.
PMID: 39441580DERIVEDSilverberg JI, Leshem YA, Calimlim BM, McDonald J, Litcher-Kelly L. Psychometric evaluation of the Worst Pruritus Numerical Rating Scale (NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS). Curr Med Res Opin. 2023 Oct;39(10):1289-1296. doi: 10.1080/03007995.2023.2251883. Epub 2023 Sep 13.
PMID: 37691437DERIVEDThyssen JP, Thaci D, Bieber T, Gooderham M, de Bruin-Weller M, Soong W, Kabashima K, Barbarot S, Luna PC, Xu J, Hu X, Liu Y, Raymundo EM, Calimlim BM, Nduaka C, Gamelli A, Simpson EL. Upadacitinib for moderate-to-severe atopic dermatitis: Stratified analysis from three randomized phase 3 trials by key baseline characteristics. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1871-1880. doi: 10.1111/jdv.19232. Epub 2023 Jun 21.
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PMID: 34023009DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 14, 2018
First Posted
June 26, 2018
Study Start
August 9, 2018
Primary Completion
February 16, 2021
Study Completion (Estimated)
October 23, 2030
Last Updated
December 23, 2025
Results First Posted
March 31, 2022
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- 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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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 and 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.