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A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568318
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Upadacitinib Drug: Placebo for Upadacitinib Drug: Topical corticosteroids (TCS) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 9, 2018
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : August 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Arm Intervention/treatment
Experimental: Arm A
Upadacitinib Dose A is administered once daily along with Topical corticosteroids (TCS).
Drug: Upadacitinib
It is administered orally.
Other Names:
  • ABT-494
  • Rinvoq

Drug: Topical corticosteroids (TCS)
It is administered concomitantly with Upadacitinib or Placebo.

Experimental: Arm B
Upadacitinib Dose B is administered once daily along with Topical corticosteroids (TCS).
Drug: Upadacitinib
It is administered orally.
Other Names:
  • ABT-494
  • Rinvoq

Drug: Topical corticosteroids (TCS)
It is administered concomitantly with Upadacitinib or Placebo.

Experimental: Arm C
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
Drug: Upadacitinib
It is administered orally.
Other Names:
  • ABT-494
  • Rinvoq

Drug: Placebo for Upadacitinib
It is administered orally.

Drug: Topical corticosteroids (TCS)
It is administered concomitantly with Upadacitinib or Placebo.

Experimental: Arm D
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
Drug: Upadacitinib
It is administered orally.
Other Names:
  • ABT-494
  • Rinvoq

Drug: Placebo for Upadacitinib
It is administered orally.

Drug: Topical corticosteroids (TCS)
It is administered concomitantly with Upadacitinib or Placebo.




Primary Outcome Measures :
  1. Percentage of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) [ Time Frame: At Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).

  2. Percentage of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.


Secondary Outcome Measures :
  1. Percentage of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 for participants with pruritus NRS ≥ 4 at Baseline [ Time Frame: Up to Week 16 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

  2. Percentage of participants achieving EASI 90 [ Time Frame: Up to Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

  3. Percentage of participants achieving EASI 75 [ Time Frame: Up to Week 4 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

  4. Percentage of participants in Arm A and Arm C achieving EASI 100 [ Time Frame: At Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

  5. Percentage of participants in Arm A or Arm C achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years of age
  • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit
  • Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
  • Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568318


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
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United States, Alabama
Total Skin and Beauty Derm Ctr /ID# 200548 Recruiting
Birmingham, Alabama, United States, 35205
Clinical Research Center AL /ID# 201865 Recruiting
Birmingham, Alabama, United States, 35209-6802
Horizon Research Partners, LLC /ID# 213550 Recruiting
Mobile, Alabama, United States, 36605-3004
United States, Arizona
Arizona Research Center, Inc. /ID# 200546 Recruiting
Phoenix, Arizona, United States, 85053-4061
Investigate MD /ID# 201257 Recruiting
Scottsdale, Arizona, United States, 85255-4134
University of Arizona /ID# 201059 Recruiting
Tucson, Arizona, United States, 85719
United States, California
Bakersfield Derma & Skin Cance /ID# 200892 Completed
Bakersfield, California, United States, 93309
University of California Irvine /ID# 200902 Recruiting
Irvine, California, United States, 92697-1385
Therapeutics Clinical Research /ID# 200593 Recruiting
San Diego, California, United States, 92123
Mosaic Dermatology /ID# 200553 Recruiting
Santa Monica, California, United States, 90404
Stanford University /ID# 200597 Recruiting
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Anchutz Medical Campus /ID# 202822 Recruiting
Aurora, Colorado, United States, 80045-2517
Colorado Dermatology /ID# 203626 Recruiting
Centennial, Colorado, United States, 80111-1724
Western States Clinical Research, Inc. /ID# 201702 Recruiting
Wheat Ridge, Colorado, United States, 80033-2896
United States, Connecticut
Dermatology Physicians of CT /ID# 201004 Recruiting
Shelton, Connecticut, United States, 06484-6211
United States, Florida
Clearlyderm Dermatology /ID# 207709 Recruiting
Boca Raton, Florida, United States, 33433-3424
Skin Care Research, LLC /ID# 200812 Recruiting
Boca Raton, Florida, United States, 33486-2269
Clinical Res of West FL, Inc. /ID# 203643 Recruiting
Clearwater, Florida, United States, 33765
Florida Academic Centers Research and Education /ID# 200544 Recruiting
Coral Gables, Florida, United States, 33134
ACCEL Research Sites /ID# 213364 Recruiting
DeLand, Florida, United States, 32720
Sullivan Dermatology /ID# 201174 Recruiting
North Miami Beach, Florida, United States, 33162-4708
Park Avenue Dermatology, PA /ID# 201012 Recruiting
Orange Park, Florida, United States, 32073
Precision Clinical Research /ID# 208734 Recruiting
Sunrise, Florida, United States, 33351-7311
United States, Idaho
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628 Recruiting
Boise, Idaho, United States, 83713
United States, Illinois
Northwestern University Feinberg School of Medicine /ID# 201646 Recruiting
Chicago, Illinois, United States, 60611-2927
Northshore University Health System-Evanston /ID# 200556 Recruiting
Evanston, Illinois, United States, 60201
DuPage Medical Group /ID# 202065 Recruiting
Wheaton, Illinois, United States, 60189-3801
United States, Indiana
Deaconess Clinic Downtown /ID# 201001 Completed
Evansville, Indiana, United States, 47713-1227
Indiana University /ID# 200515 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas City Dermatology PA /ID# 203026 Recruiting
Overland Park, Kansas, United States, 66215
United States, Massachusetts
ORA Clinical Res & Development /ID# 202824 Recruiting
Andover, Massachusetts, United States, 01810
Tufts Medical Center /ID# 200570 Recruiting
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center /ID# 200545 Recruiting
Boston, Massachusetts, United States, 02215-5400
United States, Michigan
Clin Res Inst of Michigan, LLC /ID# 208020 Recruiting
Chesterfield, Michigan, United States, 48047
Clarkston Skin Research /ID# 200560 Recruiting
Clarkston, Michigan, United States, 48346
United States, Missouri
MediSearch Clinical Trials /ID# 201006 Recruiting
Saint Joseph, Missouri, United States, 64506-2459
United States, Nebraska
Skin Specialists, PC /ID# 200573 Recruiting
Omaha, Nebraska, United States, 68144
United States, New Hampshire
Darmouth-Hitchcock Medical Cen /ID# 200918 Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Psoriasis Treatment Ctr NJ /ID# 200714 Recruiting
East Windsor, New Jersey, United States, 08520
United States, New York
Juva Skin and Laser Center /ID# 200997 Recruiting
New York, New York, United States, 10022-3204
Joseph Schwartz MD Medical Cosmetic Derm /ID# 202122 Recruiting
Troy, New York, United States, 12180-2323
United States, Ohio
Bexley Dermatology Research /ID# 200899 Recruiting
Bexley, Ohio, United States, 43209-2422
The Ohio State University /ID# 200542 Recruiting
Columbus, Ohio, United States, 43210-1257
United States, Oklahoma
Vital Prospects Clinical Research Institution /ID# 200901 Recruiting
Tulsa, Oklahoma, United States, 74136-7049
United States, Oregon
Oregon Derm & Res. Ctr /ID# 200601 Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pittsburgh MC /ID# 206057 Recruiting
Pittsburgh, Pennsylvania, United States, 15260
United States, Rhode Island
Rhode Island Hospital /ID# 200566 Recruiting
Providence, Rhode Island, United States, 02903
United States, Tennessee
Rivergate Dermatology & Skin Care Center /ID# 201698 Recruiting
Goodlettsville, Tennessee, United States, 37072-2301
Stones River Dermatology /ID# 204962 Completed
Murfreesboro, Tennessee, United States, 37129-3194
United States, Texas
Arlington Research Center, Inc /ID# 200559 Recruiting
Arlington, Texas, United States, 76011
Center for Clinical Studies /ID# 200582 Recruiting
Houston, Texas, United States, 77004
Progressive Clinical Research /ID# 201582 Recruiting
San Antonio, Texas, United States, 78229
Center for Clinical Studies - Webster TX /ID# 203186 Recruiting
Webster, Texas, United States, 77598
United States, Utah
Advanced Clinical Research - Woseth Dermatology /ID# 213745 Recruiting
Salt Lake City, Utah, United States, 84117-4209
United States, Virginia
Eastern Virginia Med School /ID# 200994 Recruiting
Norfolk, Virginia, United States, 23507-1627
United States, Washington
Dermatology Associates /ID# 200717 Recruiting
Seattle, Washington, United States, 98101
United States, Wisconsin
University of Wisconsin - Madison /ID# 204933 Recruiting
Madison, Wisconsin, United States, 53715-1218
Australia, New South Wales
St George Dermatology & Skin Cancer Centre /ID# 204788 Recruiting
Kogarah, New South Wales, Australia, 2217
Royal North Shore Hospital /ID# 204639 Recruiting
Saint Leonards, New South Wales, Australia, 2065
Westmead Hospital /ID# 205682 Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Veracity Clinical Research /ID# 204793 Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Western Australia
Fremantle Dermatology /ID# 205306 Recruiting
Fremantle, Western Australia, Australia, 6160
Austria
Kepler Universitätsklinikum /ID# 201075 Recruiting
Linz, Oberoesterreich, Austria, 4021
Medizinische Universitat Wien, Universitatsklinik fur Dermatologie /ID# 201080 Recruiting
Vienna, Wien, Austria, 1090
Medical University Innsbruck /ID# 210897 Recruiting
Innsbruck, Austria, 6020
Ordensklinikum Linz GmbH, Elisabethinen /ID# 209567 Recruiting
Linz, Austria, 4020
Belgium
UZ Brussel /ID# 203557 Recruiting
Jette, Bruxelles-Capitale, Belgium, 1090
Cliniques Universitaires Saint Luc /ID# 202028 Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Gent /ID# 202030 Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Grand Hopital de Charleroi /ID# 202029 Recruiting
Loverval, Belgium, 6280
Canada, Alberta
Dermatology Research Institute Inc. /ID# 200341 Recruiting
Calgary, Alberta, Canada, T1Y 0B4
Kirk Barber Research, CA /ID# 200329 Recruiting
Calgary, Alberta, Canada, T2G 1B1
Alberta DermaSurgery Centre /ID# 205674 Recruiting
Edmonton, Alberta, Canada, T6G 1C3
Canada, Newfoundland and Labrador
Karma Clinical Trials /ID# 200339 Recruiting
St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
Canada, Nova Scotia
Eastern Canada Cutaneous Resea /ID# 200335 Recruiting
Halifax, Nova Scotia, Canada, B3H 1Z2
Canada, Ontario
Lynderm Research Inc. /ID# 200338 Recruiting
Markham, Ontario, Canada, L3P 1X2
DermEdge Research Inc. /ID# 200337 Recruiting
Mississauga, Ontario, Canada, L5H 1G9
The Centre for Clinical Trials /ID# 205404 Recruiting
Oakville, Ontario, Canada, L6J 7W5
JRB Research /ID# 212653 Recruiting
Ottawa, Ontario, Canada, K1H 7X3
Dr. Melinda Gooderham Medicine /ID# 200331 Recruiting
Peterborough, Ontario, Canada, K9J 5K2
Ctr for Derma & Cosmetic Surge /ID# 205409 Recruiting
Richmond Hill, Ontario, Canada, L4B 1A5
Toronto Research Centre /ID# 205411 Recruiting
Toronto, Ontario, Canada, M3H 5Y8
Research Toronto /ID# 205410 Recruiting
Toronto, Ontario, Canada, M4W 2N2
XLR8 Medical Research /ID# 205405 Recruiting
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
CHU Sainte-Justine /ID# 206013 Recruiting
Montreal, Quebec, Canada, H3T 1C5
Ctr Derma du QC Metropolitain /ID# 205403 Recruiting
Quebec City, Quebec, Canada, G1V 4X7
Dre. Angelique Gagne-Henley /ID# 200330 Recruiting
St-Jerome, Quebec, Canada, J7Z 7E2
China, Guangdong
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728 Recruiting
Guangzhou, Guangdong, China, 510120
China, Hunan
Xiangya Hospital Central South University /ID# 207510 Recruiting
Changsha, Hunan, China, 410008
China, Liaoning
First Hospital of China Medical University /ID# 209840 Active, not recruiting
Shenyang, Liaoning, China, 110001
China, Shanghai
Huashan Hospital of Fudan University /ID# 207437 Recruiting
Shanghai, Shanghai, China, 200040
China, Zhejiang
1st Hosp College Med Zhejian /ID# 207132 Active, not recruiting
Hangzhou, Zhejiang, China, 310003
The Second Affiliated Hospital /ID# 207442 Recruiting
Hangzhou, Zhejiang, China, 310009
China
Beijing Friendship Hospital /ID# 207434 Active, not recruiting
Beijing, China, 100050
The General hospital of people's Liberation Amy(301 hospital) /ID# 206786 Recruiting
Beijing, China, 100853
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669 Recruiting
Wuhan, China, 430022
Czechia
Fakultni nemocnice Plzen /ID# 202044 Recruiting
Plzeň 1, Plzen-jih, Czechia, 301 00
Sanatorium prof. Arenbergera /ID# 202082 Recruiting
Prague 1, Praha 1, Czechia, 110 00
Vseobecna fakultni nemoc Praze /ID# 202045 Recruiting
Prague 2, Czechia, 128 08
Vseobecna Fakultni Nemocnice /ID# 205248 Recruiting
Prague, Czechia, 128 08
France
Hopital Saint-Andre /ID# 206129 Recruiting
Bordeaux, France, 33075
Hopital de la Timone /ID# 206128 Recruiting
Marseille, France, 13385
Hopital de L'archet 2 /ID# 205780 Recruiting
Nice, France, 06202
Polyclinique Courlancy /ID# 201537 Recruiting
Reims, France, 51100
Germany
Universitaetsklinik Heidelberg /ID# 202097 Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
CMS3 Company for Medical Study /ID# 205195 Recruiting
Selters, Rheinland-Pfalz, Germany, 56242
Universitaets-Hautklinik Kiel /ID# 202256 Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Universitaetsklinikum Bonn /ID# 202092 Recruiting
Bonn, Germany, 53113
Universitaetsklinikum Frankfurt /ID# 202095 Recruiting
Frankfurt, Germany, 60590
TFS Trial Form Support GmbH /ID# 202096 Recruiting
Hamburg, Germany, 20354
Med Hochschule Hanover /ID# 202098 Recruiting
Hannover, Germany, 30625
Univ Johannes Gutenberg /ID# 205194 Recruiting
Mainz, Germany, 55131
Universitatsklinikum Munster /ID# 202094 Recruiting
Muenster, Germany, 48149
TU Uniklinik Munchen /ID# 202093 Recruiting
Munich, Germany, 80802
Greece
General Univ Hosp "Attikon" /ID# 201126 Recruiting
Athens, Attiki, Greece, 12562
Papageorgiou General Hospital Thessaloniki /ID# 202392 Recruiting
Thessaloniki, Nea Efkarpia, Greece, 54603
401 GSNA - 401 Army Gen Hosp /ID# 211963 Recruiting
Athens, Greece, 11525
Genl Hospital Andreas Syggros /ID# 201123 Recruiting
Athens, Greece, 16121
Hosp Skin and Venereal Dis /ID# 201124 Recruiting
Thessaloniki, Greece, 54643
Hong Kong
Queen Mary Hospital /ID# 205146 Recruiting
Hong Kong, Hong Kong, 999077
Prince of Wales Hospital /ID# 205152 Recruiting
Sha Tin, Hong Kong
Hungary
Oroshazi Korhaz /ID# 203525 Recruiting
Orosháza, Bekes, Hungary, 5900
Debreceni Egyetem Klinikai Központ /ID# 201765 Recruiting
Debrecen, Hungary, 4032
Szegedi Tudomanyegyetem /ID# 204144 Recruiting
Szeged, Hungary, 6720
Allergo-Derm Bakos /ID# 205361 Recruiting
Szolnok, Hungary, 5000
Ireland
St. James's Hospital /ID# 201118 Recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
South Infirmary Victoria Univ /ID# 201079 Recruiting
Cork, Ireland
University Hospital Waterford /ID# 201253 Recruiting
Waterford, Ireland, X91 ER8E
Israel
Soroka Medical Center /ID# 206652 Recruiting
Be'er Sheva, HaDarom, Israel, 84101
Rabin Medical Center /ID# 201959 Recruiting
Petach Tikva, Tel-Aviv, Israel, 4941492
HaEmek Medical Center /ID# 201958 Recruiting
Afula, Israel, 1834111
Sheba Medical Center /ID# 201611 Recruiting
Ramat Gan, Israel, 5262100
Ichilov Medical Center /ID# 201608 Recruiting
Tel Aviv, Israel, 64239
Italy
AOU Federico II /ID# 200751 Recruiting
Naples, Campania, Italy, 80131
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 200744 Recruiting
Milan, Lombardia, Italy, 20122
Istituto Clinico Humanitas /ID# 200739 Recruiting
Rozzano, Milano, Italy, 20089
Università Cattolica Sacro Cuore /ID# 203014 Recruiting
Rome, Roma, Italy, 00168
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690 Recruiting
Ancona, Italy, 60126
Universita di Catania /ID# 200742 Recruiting
Catania, Italy, 95123
Japan
Chukyo Hospital /ID# 202311 Active, not recruiting
Nagoya-shi, Aichi, Japan, 457-8510
Medical Corporation Matsuo Clinic /ID# 202312 Active, not recruiting
Fukuoka-shi, Fukuoka, Japan, 8190373
HIRAMOTO skin clinic /ID# 204048 Active, not recruiting
Amagasaki-shi, Hyogo, Japan, 6610953
National Hospital Organization Sagamihara National Hospital /ID# 201658 Active, not recruiting
Sagamihara-shi, Kanagawa, Japan, 252-0315
Queen's Square Medical Center dermatology, allergology /ID# 203850 Active, not recruiting
Yokohama City, Kanagawa, Japan, 2206208
Tohoku University Hospital /ID# 206322 Active, not recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Osaka Habikino Medical Center /ID# 204243 Active, not recruiting
Habikino-shi, Osaka, Japan, 5838588
Kyoto University Hospital /ID# 201654 Active, not recruiting
Kyoto, Sakyo-ku, Japan, 606-8507
Jichi Medical University Hospital /ID# 201913 Active, not recruiting
Shimotsuke-shi, Tochigi, Japan, 329-0498
Juntendo University Hospital /ID# 202888 Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Tokai University Hachioji Hospital /ID# 201711 Active, not recruiting
Hachioji, Tokyo, Japan, 192-0032
Maruyama Dermatology Clinic /ID# 202350 Active, not recruiting
Koto-ku, Tokyo, Japan, 1360074
Yamate Dermatological Clinic /ID# 202130 Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 1690075
Hiroshima University Hospital /ID# 201914 Completed
Hiroshima, Japan, 734-8551
Netherlands
Academisch Medisch Centrum /ID# 202193 Recruiting
Amsterdam, Netherlands, 1105 AZ
Universitair Medisch Centrum Groningen /ID# 202195 Recruiting
Groningen, Netherlands, 9713 GZ
Erasmus Medisch Centrum /ID# 202196 Recruiting
Rotterdam, Netherlands, 3015 CE
Universitair Medisch Centrum Utrecht /ID# 202194 Recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
Clinical Trials NZ /ID# 205336 Recruiting
Hamilton, New Zealand, 3206
Norway
Haukeland University Hospital /ID# 201152 Recruiting
Bergen, Hordaland, Norway, 5021
Universitetssykehuset N-Norge, Harstad /ID# 201269 Recruiting
Harstad, Troms, Norway, 9406
Universitetssykehuset N-Norge, Tromsø /ID# 201270 Recruiting
Tromsø, Troms, Norway, 9019
Rikshospitalet OUS HF /ID# 201271 Recruiting
Oslo, Norway, 0450
Puerto Rico
Dr. Samuel Sanchez, PSC /ID# 202002 Recruiting
Caguas, Puerto Rico, 00727
GCM Medical Group /ID# 202003 Recruiting
San Juan, Puerto Rico, 00909
Clinical Research Puerto Rico /ID# 203644 Recruiting
San Juan, Puerto Rico, 0090
Slovakia
FNsP F.D.Roosevelta Banska Bys /ID# 204372 Recruiting
Banska Bystrica, Banskobystricky Kraj, Slovakia, 975 17
FNsP Nove Zamky /ID# 204240 Recruiting
Nové Zámky, Nitriansky Kraj, Slovakia, 940 02
Univerzitna nemocnica Martin /ID# 203851 Recruiting
Martin, Zilinsky Kraj, Slovakia, 036 01
FNsP J.A. Reimana /ID# 204373 Recruiting
Presov, Slovakia, 081 01
Spain
Hospital General Univ Alicante /ID# 200873 Recruiting
Alicante, Spain, 03550
Hospital Santa Creu i Sant Pau /ID# 201325 Recruiting
Barcelona, Spain, 08026
Hospital Univ de la Princesa /ID# 201517 Recruiting
Madrid, Spain, 28006
Hosp Univ 12 de Octubre /ID# 201135 Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz /ID# 205438 Recruiting
Madrid, Spain, 28046
Hospital Univ de Puerto Real /ID# 200875 Recruiting
Puerto Real, Spain, 11510
Sweden
Skane University Hospital Lund /ID# 201244 Recruiting
Lund, Skane Lan, Sweden, SE 221 41
Hudkliniken SU/Sahlgrenska /ID# 201274 Recruiting
Goteborg, Sweden, 41345
Sodersjukhuset /ID# 201242 Recruiting
Stockholm, Sweden, 11883
Karolinska University Hospital /ID# 201243 Recruiting
Stockholm, Sweden, SE-17176
United Kingdom
St. Thomas Hospital /ID# 204642 Recruiting
London, England, United Kingdom, SE1 7EH
Whipps Cross Univ Hospital /ID# 201044 Recruiting
London, London, City Of, United Kingdom, E11 1NR
Guy's and St Thomas' NHS Found /ID# 201193 Recruiting
London, London, City Of, United Kingdom, SE1 9RT
Ninewells Hospital /ID# 202081 Recruiting
Dundee, United Kingdom, DD1 9SY
Chapel Allerton Hospital /ID# 201106 Recruiting
Leeds, United Kingdom, LS7 4SA
Churchill Hospital /ID# 202052 Recruiting
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03568318     History of Changes
Other Study ID Numbers: M16-047
2017-005126-37 ( EudraCT Number )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Atopic Dermatitis
Upadacitinib
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases