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Trial record 1 of 1 for:    M18-891
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A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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: NCT03607422
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe AD who are candidates for systemic therapy.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Upadacitinib Drug: Placebo for Upadacitinib 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 Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : July 27, 2018
Estimated Primary Completion Date : February 14, 2020
Estimated Study Completion Date : August 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Arm A
Upadacitinib Dose A is administered once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Experimental: Arm B
Upadacitinib Dose B is administered once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Experimental: Arm C
Placebo administered once daily followed by Upadacitinib Dose A once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Drug: Placebo for Upadacitinib
It is administered orally.

Experimental: Arm D
Placebo administered once daily followed by Upadacitinib Dose B once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Drug: Placebo for Upadacitinib
It is administered orally.




Primary Outcome Measures :
  1. Proportion 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. Proportion 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. Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from 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. Proportion 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. Proportion of participants achieving EASI 50 [ Time Frame: At Week 1 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

  4. Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline at day 2 for participants randomized to dose A [ Time Frame: At Day 2 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

  5. Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline at day 3 for participants randomized to dose B [ Time Frame: At Day 3 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

  6. Proportion of participants achieving an improvement (reduction) in Atopic dermatitis impact scale (ADerm-IS) sleep domain score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-IS sleep domain score ≥ MCID.

  7. Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) skin pain score ≥ MCID [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-SS skin pain score ≥ MCID.

  8. Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) total score ≥ MCID [ Time Frame: Up to Week 16 ]
    This is assessed for participants with ADerm-SS total score ≥ MCID.

  9. Proportion of participants achieving an improvement (reduction) in ADerm-IS total score ≥ MCID [ Time Frame: Up to Week 16 ]
    This is assessed for participants with ADerm-IS total score ≥ MCID.

  10. Proportion of participants 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.

  11. Proportion of participants achieving vIGA-AD of 0 with a reduction of ≥ 2 points [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.

  12. Proportion 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.



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:

  • 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

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor
  • Unable or unwilling to discontinue current 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): NCT03607422


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

  Hide Study Locations
Locations
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United States, Alabama
Total Skin and Beauty Derm Ctr /ID# 205129 Recruiting
Birmingham, Alabama, United States, 35205
United States, Arizona
Medical Dermatology Specialist /ID# 205516 Recruiting
Phoenix, Arizona, United States, 85006-2722
Arizona Research Center, Inc. /ID# 205795 Recruiting
Phoenix, Arizona, United States, 85053-4061
United States, California
Wallace Medical Group, Inc. /ID# 205701 Recruiting
Beverly Hills, California, United States, 90211
Encino Research Center / T. Jo /ID# 207472 Recruiting
Encino, California, United States, 91436
University of California Irvine /ID# 205136 Recruiting
Irvine, California, United States, 92697-1385
Keck School of Medicine of USC /ID# 206971 Recruiting
Los Angeles, California, United States, 90033
Child Hosp of Orange County,CA /ID# 205735 Recruiting
Orange, California, United States, 92868
UCSD Rady's Children's Hospital /ID# 208244 Recruiting
San Diego, California, United States, 92123-4232
Southern California Derma. Inc /ID# 205734 Recruiting
Santa Ana, California, United States, 92701
United States, Colorado
Innovative Clinical Research - Lafayette /ID# 208400 Recruiting
Lafayette, Colorado, United States, 80026
United States, Connecticut
New England Research Associates, LLC /ID# 206896 Recruiting
Bridgeport, Connecticut, United States, 06606-1827
United States, Florida
Ideal Clinical Research Inc. /ID# 209880 Recruiting
Aventura, Florida, United States, 33180
Skin Care Research, LLC /ID# 207099 Recruiting
Boca Raton, Florida, United States, 33486-2269
Midflorida Clinical Research, Inc. /ID# 213700 Recruiting
Brandon, Florida, United States, 33511-5335
Clinical Res of West FL, Inc. /ID# 206146 Recruiting
Clearwater, Florida, United States, 33765
Revival Research /ID# 208383 Recruiting
Doral, Florida, United States, 33122-1902
Universal Axon Clinical Resear /ID# 213703 Recruiting
Doral, Florida, United States, 33166
Floridian Clinical Research /ID# 207433 Recruiting
Hialeah, Florida, United States, 33016-1842
Savin Medical Group, LLC /ID# 206902 Recruiting
Miami Lakes, Florida, United States, 33014-2490
Lakes Research, LLC /ID# 209156 Recruiting
Miami, Florida, United States, 33014
Miami Dade Medical Research In /ID# 209413 Recruiting
Miami, Florida, United States, 33176
Ormond Medical Arts Pharmaceutical Research Center /ID# 213459 Recruiting
Ormond Beach, Florida, United States, 32174-6302
Precision Clinical Research /ID# 207364 Recruiting
Sunrise, Florida, United States, 33351-7311
Clinical Research Trials of Florida, Inc. /ID# 206840 Recruiting
Tampa, Florida, United States, 33607
ForCare Clinical Research /ID# 205120 Recruiting
Tampa, Florida, United States, 33613-1244
United States, Georgia
Marietta Dermatology Clinical Research /ID# 210317 Recruiting
Marietta, Georgia, United States, 30060-1047
United States, Idaho
Treasure Valley Medical Research /ID# 210298 Recruiting
Boise, Idaho, United States, 83706
United States, Illinois
Great Lakes Clinical Trials /ID# 205830 Recruiting
Chicago, Illinois, United States, 60640
Northshore University Health System-Evanston /ID# 205135 Recruiting
Evanston, Illinois, United States, 60201
Ashira Dermatology /ID# 205512 Recruiting
Gurnee, Illinois, United States, 60031-3393
Clinical Investigation Specialists, Inc. /ID# 206898 Recruiting
Gurnee, Illinois, United States, 60031
United States, Indiana
Raga Clinical Studies, LLC. /ID# 206749 Recruiting
Crown Point, Indiana, United States, 46307
United States, Kansas
Hutchinson Clinic /ID# 205970 Recruiting
Hutchinson, Kansas, United States, 67502-1131
United States, Maryland
Continental Clinical Solutions /ID# 210327 Recruiting
Towson, Maryland, United States, 21204
United States, Massachusetts
Beacon Clinical Research, LLC /ID# 206894 Recruiting
Quincy, Massachusetts, United States, 02169
United States, Michigan
David Fivenson, MD, PLC /ID# 206903 Recruiting
Ann Arbor, Michigan, United States, 48103
University of Michigan Hospitals /ID# 206895 Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
Skin Specialists, PC /ID# 205515 Recruiting
Omaha, Nebraska, United States, 68144
United States, New Jersey
Summit Medical Group /ID# 213863 Not yet recruiting
Clifton, New Jersey, United States, 07012-1647
Skin Laser and Surgery Specialists /ID# 206754 Recruiting
Hackensack, New Jersey, United States, 07601-1997
United States, New Mexico
University of New Mexico School of Medicine /ID# 206756 Recruiting
Albuquerque, New Mexico, United States, 87131-0001
United States, North Carolina
PMG Research of Wilmington LLC /ID# 205968 Recruiting
Wilmington, North Carolina, United States, 28401
United States, Ohio
University Hospitals Case Medical Center /ID# 206639 Recruiting
Cleveland, Ohio, United States, 44106
Awasty Research Network, LLC /ID# 206748 Recruiting
Marion, Ohio, United States, 43302-6225
United States, Oklahoma
Southside Dermatology /ID# 214451 Recruiting
Tulsa, Oklahoma, United States, 74135-5618
Vital Prospects Clinical Research Institution /ID# 205824 Recruiting
Tulsa, Oklahoma, United States, 74136-7049
United States, Oregon
Clinical Research Institute of Southern Oregon /ID# 207544 Recruiting
Medford, Oregon, United States, 97504-9741
United States, Tennessee
Stones River Dermatology /ID# 205178 Completed
Murfreesboro, Tennessee, United States, 37129-3194
United States, Texas
Metroplex Dermatology /ID# 213307 Recruiting
Arlington, Texas, United States, 76014
Bellaire Dermatology /ID# 205470 Recruiting
Bellaire, Texas, United States, 77401
Center for Clinical Studies /ID# 213186 Recruiting
Cypress, Texas, United States, 77433
Derm Treatment and Res Ctr /ID# 205473 Recruiting
Dallas, Texas, United States, 75230
Epiphany Dermatology /ID# 210073 Recruiting
Fort Worth, Texas, United States, 76244-6548
Styde Research, LLC /ID# 213469 Recruiting
Lewisville, Texas, United States, 75067
Austin Center for Clinical Research /ID# 206640 Recruiting
Pflugerville, Texas, United States, 78660
Derm Clin Res Ctr San Antonio /ID# 205469 Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
EPIC Medical Research /ID# 206382 Recruiting
Murray, Utah, United States, 84123-5632
Aspen Clinical Research /ID# 208399 Recruiting
Orem, Utah, United States, 84058
United States, Vermont
Timber Lane Allergy & Asthma Research, LLC /ID# 206897 Recruiting
South Burlington, Vermont, United States, 05403-7204
United States, Virginia
The Education & Research Foundation, Inc. /ID# 206900 Recruiting
Lynchburg, Virginia, United States, 24501-1403
United States, Washington
Bellingham Asthma Allergy and Immunology Clinic /ID# 210357 Recruiting
Bellingham, Washington, United States, 98225-1945
American Samoa
Palmtree Clinical Research Inc. /Id# 206184 Recruiting
Palm Springs, American Samoa, 92262
Australia, Queensland
The Skin Centre /ID# 205922 Recruiting
Benowa, Queensland, Australia, 4217
Australia, Victoria
Box Hill Hospital /ID# 206023 Recruiting
Melbourne, Victoria, Australia, 3128
Royal Melbourne Hospital /ID# 205919 Recruiting
Parkville, Victoria, Australia, 3050
Murdoch Children's Research Institute /ID# 205667 Recruiting
Parkville, Victoria, Australia, 3052
Austria
University Hospital St. Polten /ID# 206909 Recruiting
St. Pölten, Niederoesterreich, Austria, 3100
Ordensklinikum Linz GmbH, Elisabethinen /ID# 206573 Recruiting
Linz, Austria, 4020
Salzburger Landeskliniken (SALK) /ID# 208281 Recruiting
Salzburg, Austria, 5020
Sozialmedizinisches Zentrum Ost - Donauspital /ID# 206572 Recruiting
Vienna, Austria, 1220
Belgium
Cliniques Universitaires Saint Luc /ID# 205537 Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Gent /ID# 205181 Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Centre Hospitalier Universitaire du Sart Tilman (CHU de Liège) /ID# 204938 Recruiting
Liège, Belgium, 4000
Bulgaria
Medical Center "Sv. Panteleimon" /ID# 210414 Recruiting
Sofia, Bulgaria, 1000
Acibadem City Clinic Tokuda /ID# 205292 Recruiting
Sofia, Bulgaria, 1407
Military Medical Academy Multiprofile Hospital /ID# 205291 Recruiting
Sofia, Bulgaria, 1606
Medical Center Doverie /ID# 211289 Recruiting
Sofia, Bulgaria, 1632
Canada, Alberta
Stratica Medical /ID# 205415 Recruiting
Edmonton, Alberta, Canada, T5K 2V4
Alberta DermaSurgery Centre /ID# 205422 Recruiting
Edmonton, Alberta, Canada, T6G 1C3
Canada, British Columbia
Univ British Columbia /ID# 207837 Recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
Pacific Derm /ID# 206797 Recruiting
Vancouver, British Columbia, Canada, V6H 4E1
Canada, Newfoundland and Labrador
Dr. Brown-Maher PMC INC. /ID# 205420 Recruiting
St. John's, Newfoundland and Labrador, Canada, A1E 1V4
Canada, Ontario
SimcoMed Health Ltd /ID# 206333 Recruiting
Barrie, Ontario, Canada, L4M 7G1
Kingsway Clinical Research /ID# 206005 Recruiting
Etobicoke, Ontario, Canada, M8X 1Y9
Guenther Derma Res Ctr, CA /ID# 206772 Recruiting
London, Ontario, Canada, N6A 3H7
DermEdge Research Inc. /ID# 206036 Recruiting
Mississauga, Ontario, Canada, L5H 1G9
Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138 Recruiting
Newmarket, Ontario, Canada, L3Y 5G8
Allergy Research Canada Inc. /ID# 213547 Recruiting
Niagara Falls, Ontario, Canada, L2H 1H5
Sudbury Skin Clinique /ID# 206771 Recruiting
Sudbury, Ontario, Canada, P3E 5M4
Niakosari Medicine Professional Corporation /ID# 206004 Recruiting
Toronto, Ontario, Canada, M2M 4J5
Canada, Saskatchewan
Skinsense Medical Research /ID# 206873 Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0H6
Canada
Guelph Dermatology Research /ID# 206890 Recruiting
Guelph, Canada, N1L 0B7
Croatia
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Poliklinika Vlatka Cavka d.o.o. /ID# 211126 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448 Recruiting
Ivanić-Grad, Zagrebacka Zupanija, Croatia, 10310
Djecja bolnica Srebrnjak /ID# 205926 Recruiting
Zagreb, Croatia, 10000
Czechia
Fakultni nemocnice Plzen /ID# 205096 Recruiting
Plzeň 1, Plzen-jih, Czechia, 301 00
Sanatorium prof. Arenbergera /ID# 205098 Recruiting
Prague 1, Praha 1, Czechia, 110 00
Vseobecna Fakultni Nemocnice /ID# 205201 Recruiting
Prague, Czechia, 128 08
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097 Recruiting
Usti nad Labem, Czechia, 40113
Denmark
Aarhus University Hospital /ID# 205524 Recruiting
Aarhus N, Midtjylland, Denmark, 8200
Sjaellands Universitets Hospit /ID# 205960 Recruiting
Roskilde, Sjælland, Denmark, 4000
France
Hopital Prive d'Antony /ID# 206553 Recruiting
Antony, Ile-de-France, France, 92160
Hopital Saint-Andre /ID# 206554 Recruiting
Bordeaux, France, 33075
CHRU de Brest - Hopital Morvan /ID# 206555 Recruiting
Brest, France, 29200
C.H. de Bretagne Sud /ID# 206910 Recruiting
Lorient, France, 56322
Hopital Saint Louis /ID# 206552 Recruiting
Paris, France, 75475
Germany
Gemeinschaftspraxis /ID# 205765 Recruiting
Blankenfeld-mahlow, Germany, 15831
Klinikum Darmstadt GmbH /ID# 207483 Recruiting
Darmstadt, Germany, 64297
Universitaetklinikum Dresden /ID# 205767 Recruiting
Dresden, Germany, 01307
Univ Klinik Eppendorf Hamburg /ID# 207982 Not yet recruiting
Hamburg, Germany, 20246
Univ Hosp Schleswig-Holstein /ID# 206658 Recruiting
Kiel, Germany, 24105
Asefi, Simmern, DE /ID# 205768 Recruiting
Simmern, Germany, 55469
Hoffmann, Witten, DE /ID# 205766 Recruiting
Witten, Germany, 58453
Centroderm Wuppertal /ID# 206861 Recruiting
Wuppertal, Germany, 42287
Greece
Papageorgiou General Hospital Thessaloniki /ID# 204526 Recruiting
Nea Efkarpia, Thessaloniki, Greece, 54603
251 Airforce General Hospital /ID# 205841 Recruiting
Athens, Greece, 11525
Genl Hospital Andreas Syggros /ID# 204527 Recruiting
Athens, Greece, 16121
401 GSNA - 401 Army Gen Hosp /ID# 205352 Recruiting
Αthens, Greece, 11525
Hungary
Bugat Pal Korhaz /ID# 211247 Recruiting
Gyöngyös, Heves, Hungary, 3200
Pecsi Tudomanyegyetem /ID# 205085 Recruiting
Pécs, Pecs, Hungary, 7624
Clinexpert Kft. /ID# 211246 Recruiting
Budapest, Hungary, 1033
Synexus Magyarorszag Kft. /ID# 206008 Recruiting
Budapest, Hungary, 1036
Somogy Megyei Kaposi Mor Oktat /ID# 205611 Recruiting
Kaposvár, Hungary, 7400
Ireland
St. James's Hospital /ID# 204264 Recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
South Infirmary Victoria Univ /ID# 204265 Recruiting
Cork, Ireland
Galway University Hospital /ID# 209965 Recruiting
Galway, Ireland, H91 YR71
University Hospital Waterford /ID# 204266 Recruiting
Waterford, Ireland, X91 ER8E
Italy
Istituto Dermatologico San Gallicano /ID# 205986 Recruiting
Rome, Lazio, Italy, 00144
Università Cattolica Sacro Cuore /ID# 205987 Recruiting
Rome, Roma, Italy, 00168
A.O.U. di Brescia /ID# 205927 Recruiting
Brescia, Italy, 25123
Ospedale San Giovanni di Dio /ID# 205168 Recruiting
Cagliari, Italy, 9124
Ospedale San Salvatore - ASL 01 Avezzano - Sulmona - L'Aquila /ID# 205167 Recruiting
L'Aquila, Italy, 67100
AO Univ di Modena /ID# 205169 Recruiting
Modena, Italy, 41100
Korea, Republic of
Soon Chun Hyang University Hospital Bucheon /ID# 206391 Recruiting
Buncheon, Gyeonggido, Korea, Republic of, 14584
Ajou University Hospital /ID# 206341 Recruiting
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Korea University Ansan Hosp /ID# 206342 Recruiting
Gyeonggi-do, Korea, Republic of, 152-703
The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529 Recruiting
Incheon, Korea, Republic of, 21431
Seoul National University Hospital /ID# 206396 Recruiting
Seoul, Korea, Republic of, 03080
Chung-Ang University Hostipal /ID# 206397 Recruiting
Seoul, Korea, Republic of, 06973
Hallym University Kangnam Sacred Heart Hospital /ID# 206343 Recruiting
Seoul, Korea, Republic of, 07441
Netherlands
Bravis Ziekenhuis /ID# 206676 Recruiting
Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
Centrum Oosterwal /ID# 209640 Recruiting
Alkmaar, Netherlands, 1817 MS
Reinier de Graaf /ID# 205811 Recruiting
Delft, Netherlands, 2625 AD
Universitair Medisch Centrum Groningen /ID# 205162 Recruiting
Groningen, Netherlands, 9713 GZ
New Zealand
Greenlane Clinical Centre /ID# 205664 Recruiting
Auckland, New Zealand, 1051
Portugal
CCA Braga - Hospital de Braga /ID# 205854 Recruiting
Braga, Portugal, 4710-243
Centro Hospitalar de Leiria, EPE /ID# 209906 Recruiting
Leiria, Portugal, 2410-197
Centro Hospitalar Lisboa Norte, EPE /ID# 205839 Recruiting
Lisboa, Portugal, 1649-035
Hospital CUF Descobertas /ID# 205431 Recruiting
Lisbon, Portugal, 1998-018
CHP, EPE- Hospital Geral de Sa /ID# 205187 Recruiting
Porto, Portugal, 4050
Centro Hospitalar de Sao Joao, EPE /ID# 205679 Recruiting
Porto, Portugal, 4200-319
Singapore
National Skin Centre /ID# 205222 Recruiting
Singapore, Central Singapore, Singapore, 308205
National University Hospital /ID# 205224 Recruiting
Singapore, Singapore, 119074
Singapore General Hospital /ID# 205225 Recruiting
Singapore, Singapore, 169608
KK Women's & Children Hospital /ID# 206693 Recruiting
Singapore, Singapore, 229899
Changi General Hospital /ID# 205223 Recruiting
Singapore, Singapore, 529889
Spain
Hospital Vital Alvarez Buylla /ID# 205770 Recruiting
Mieres, Asturias, Spain, 33611
H. Del Mar, Barcelona /ID# 204709 Recruiting
Barcelona, Spain, 08003
Hospital Clinic de Barcelona /ID# 210564 Recruiting
Barcelona, Spain, 08036
Hospital Reina Sofia de Cordob /ID# 204712 Recruiting
Cordoba, Spain, 14004
Hospital Campus de la Salud /ID# 205544 Recruiting
Granada, Spain, 18016
Hosp Infantil Univ Nino Jesus /ID# 210437 Recruiting
Madrid, Spain, 28009
Hosp. Gral. Univ. Gregorio Mar /ID# 204380 Recruiting
Madrid, Spain, 28009
Hospital Infanta Leonor /ID# 204710 Recruiting
Madrid, Spain, 28031
Hospital General U de Valencia /ID# 210565 Recruiting
Valencia, Spain, 46014
Taiwan
National Taiwan University Hospital /ID# 204803 Recruiting
Taipei City, Taipei, Taiwan, 100
Chung Shan Medical University /ID# 205092 Recruiting
Taichung City, Taiwan, 40201
Taipei Medical University Hosp /ID# 204804 Recruiting
Taipei City, Taiwan, 11031
Linkou Chang Gung Memorial Ho /ID# 204783 Recruiting
Taoyuan City, Taiwan, 33305
United Kingdom
The Royal London Hospital /ID# 206491 Recruiting
London, London, City Of, United Kingdom, E1 1BB
Northwick Park Hospital /ID# 205250 Recruiting
Harrow, United Kingdom, HA1 3UJ
The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 204993 Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Plymouth Hospitals NHS Trust /ID# 204649 Recruiting
Plymouth, United Kingdom, PL6 8DH
Southampton General Hospital /ID# 205711 Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03607422     History of Changes
Other Study ID Numbers: M18-891
2018-001383-28 ( EudraCT Number )
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 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
ABT-494
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
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents