Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT04195698
Last Updated: 2025-01-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
475 participants
INTERVENTIONAL
2020-01-15
2023-09-11
Brief Summary
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Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Upadacitinib
Participants will be administered with upadacitinib once daily (QD)
Upadacitinib
Upadacitinib will be administered oral as tablet
Interventions
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Upadacitinib
Upadacitinib will be administered oral as tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.
Exclusion Criteria
* Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Arkansas for Medical Sciences /ID# 221021
Little Rock, Arkansas, United States
Duplicate_First OC Dermatology Research Inc /ID# 218619
Fountain Valley, California, United States
UCSF Fresno /ID# 218453
Fresno, California, United States
California Allergy and Asthma Medical Group /ID# 218635
Los Angeles, California, United States
Dermatology Research Associates /ID# 218637
Los Angeles, California, United States
Dermatology Clinical Trials /ID# 218627
Newport Beach, California, United States
Duplicate_UC Davis Health /ID# 218582
Sacramento, California, United States
Ucsd /Id# 218629
San Diego, California, United States
Clinical Science Institute /ID# 218632
Santa Monica, California, United States
Miami Dermatology and Laser Institute /ID# 218664
Miami, Florida, United States
Florida International Rsrch cr /ID# 218663
Miami, Florida, United States
GCP Research /ID# 218665
St. Petersburg, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 218438
Tampa, Florida, United States
Georgia Pollens Clinical Research Centers, Inc /ID# 218441
Albany, Georgia, United States
Medical Dermatology Associates of Chicago /ID# 218551
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552
Normal, Illinois, United States
Dawes Fretzin, LLC /ID# 218478
Indianapolis, Indiana, United States
Beacon Clinical Research, LLC /ID# 218636
Quincy, Massachusetts, United States
Duplicate_Michigan Center for Research Company /ID# 218577
Clarkston, Michigan, United States
Henry Ford Medical Center - New Center One /ID# 218575
Detroit, Michigan, United States
Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548
Lincoln, Nebraska, United States
Skin Specialists, PC /ID# 218549
Omaha, Nebraska, United States
University Hospitals Case Medical Center /ID# 218574
Cleveland, Ohio, United States
Southside Dermatology /ID# 218477
Tulsa, Oklahoma, United States
Oregon Medical Research Center /ID# 218440
Portland, Oregon, United States
Oregon Medical Research Center /ID# 218578
Portland, Oregon, United States
Duplicate_Medical University of South Carolina /ID# 221072
Charleston, South Carolina, United States
Clinical Research Solutions, LLC /ID# 218447
Jackson, Tennessee, United States
Orion Clinical Research /ID# 218565
Austin, Texas, United States
Sante Clinical Research /ID# 218911
Kerrville, Texas, United States
Clinical Research Partners, LLC /ID# 218480
Richmond, Virginia, United States
Duplicate_Premier Clinical Research /ID# 218583
Spokane, Washington, United States
West Virginia Research Inst /ID# 218479
South Charleston, West Virginia, United States
Holdsworth House Medical Practice /ID# 218755
Darlinghurst, New South Wales, Australia
The Skin Hospital /ID# 218753
Darlinghurst, New South Wales, Australia
Veracity Clinical Research /ID# 218754
Woolloongabba, Queensland, Australia
Sinclair Dermatology - Melbourne /ID# 218751
East Melbourne, Victoria, Australia
Burswood Dermatology /ID# 218752
Victoria Park, Western Australia, Australia
Kirk Barber Research, CA /ID# 218727
Calgary, Alberta, Canada
Duplicate_Dermatology Research Institute Inc. /ID# 218728
Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 218725
Surrey, British Columbia, Canada
Enverus Medical Research /ID# 218726
Surrey, British Columbia, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 218722
London, Ontario, Canada
Duplicate_Lynderm Research Inc. /ID# 218723
Markham, Ontario, Canada
DermEdge Research Inc. /ID# 218721
Mississauga, Ontario, Canada
North York Research Inc /ID# 218729
Toronto, Ontario, Canada
Duplicate_K. Papp Clinical Research /ID# 218730
Waterloo, Ontario, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 218724
Saint-Jérôme, Quebec, Canada
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 218375
Zagreb, City of Zagreb, Croatia
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376
Ivanić-Grad, Zagreb County, Croatia
Fakultni nemocnice Hradec Kralove /ID# 214176
Hradec Králové, , Czechia
Nemocnice Jihlava, prispevkova organizace /ID# 214178
Jihlava, , Czechia
Fakultni Nemocnice Ostrava /ID# 214177
Ostrava, , Czechia
Duplicate_Duplicate_Fakultni Nemocnice v Motole /ID# 214179
Prague, , Czechia
Keski-pohjanmaa Central Hospital /ID# 214630
Kokkola, Keski-Pohjanmaa, Finland
Duplicate_Oulun yliopistollinen sairaala /ID# 214628
Oulu, North Ostrobothnia, Finland
Mikkeli Central Hospital /ID# 214629
Mikkeli, , Finland
AP-HM - Hopital de la Timone /ID# 218957
Marseille, Bouches-du-Rhone, France
Polyclinique Courlancy /ID# 218955
Reims, Marne, France
CHU de Nantes, Hotel Dieu -HME /ID# 218959
Nantes, Pays de la Loire Region, France
Hôpital Charles-Nicolle /ID# 218960
Rouen, , France
CHU Toulouse - Hopital Larrey /ID# 218958
Toulouse, , France
Dermatologische Mahlow /ID# 214225
Blankenfelde-Mahlow, Brandenburg, Germany
Duplicate_Klinikum Darmstadt GmbH /ID# 214224
Darmstadt, Hesse, Germany
Universitaetsklinikum Frankfurt /ID# 214223
Frankfurt am Main, Hesse, Germany
Duplicate_Universitaetsklinikum Muenster /ID# 214222
Munster, Lower Saxony, Germany
Medizinische Hochschule Hannover /ID# 214226
Hanover, , Germany
Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221
Munich, , Germany
Oroshazi Korhaz /ID# 214986
Orosháza, Bekes County, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984
Kaposvár, Somogy County, Hungary
Uno Medical Trials Kft /ID# 214987
Budapest, , Hungary
St Vincent's University Hospital /ID# 213558
Elm Park, Dublin, Ireland
Duplicate_HaEmek Medical Center /ID# 218520
Afula, Southern District, Israel
The Chaim Sheba Medical Center /ID# 218522
Ramat Gan, Tel Aviv, Israel
Rabin Medical Center /ID# 218521
Haifa, , Israel
Istituto Clinico Humanitas /ID# 215727
Rozzano, Milano, Italy
Fondazione PTV Policlinico Tor Vergata /ID# 214093
Rome, Roma, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 214096
Modena, , Italy
Hospital Sultan Ismail /ID# 218881
Johor Bahru, Johor, Malaysia
Hospital Pakar Sultanah Fatimah /ID# 218877
Muar town, Johor, Malaysia
Hospital Putrajaya /ID# 218880
Putrajaya, Putrajaya, Malaysia
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879
Kuala Lumpur, Selangor, Malaysia
Hospital Pulau Pinang /ID# 218878
George Town, , Malaysia
University Malaya Med Ctr /ID# 218882
Kuala Lumpur, , Malaysia
Bravis Ziekenhuis /ID# 218772
Bergen op Zoom, North Brabant, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 218770
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 218775
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 218771
Utrecht, , Netherlands
Optimal Clinical Trials Ltd /ID# 218688
Grafotn, Auckland, New Zealand
Wellington Regional Hospital /ID# 218689
Newtown, Wellington Region, New Zealand
Clinical Trials New Zealand /ID# 218690
Hamilton, , New Zealand
Duplicate_Universitetssykehuset N-Norge, Tromso /ID# 214634
Tromsø, Troms, Norway
Duplicate_Pratia MCM Krakow /ID# 214303
Krakow, Lesser Poland Voivodeship, Poland
Klinika Ambroziak Sp. z o.o. /ID# 214301
Warsaw, Masovian Voivodeship, Poland
Duplicate_Duplicate_Royalderm Agnieszka Nawrocka /ID# 214302
Warsaw, Masovian Voivodeship, Poland
ClinicMed Daniluk, Nowak Sp.k. /ID# 214299
Bialystok, Podlaskie Voivodeship, Poland
Dermoklinika Centrum Medyczne s.c. /ID# 214300
Lodz, Łódź Voivodeship, Poland
National University Hospital /ID# 219093
Singapore, , Singapore
Duplicate_Hospital Universitario de Bellvitge /ID# 214257
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Dr. Negrin /ID# 214256
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital de Manises /ID# 214258
Manises, Valencia, Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 214255
Pontevedra, , Spain
Hospital Universitario Arnau Vilanova /ID# 214254
Valencia, , Spain
Hospital Universitario y Politecnico La Fe /ID# 214252
Valencia, , Spain
National Taiwan University Hospital /ID# 218917
Taipei City, Taipei, Taiwan
Chung Shan Medical University Hospital /ID# 218919
Taichung, , Taiwan
China Medical University Hospital /ID# 218409
Taichung, , Taiwan
Taipei Municipal Wan Fang Hospital /ID# 218918
Taipei, , Taiwan
Kyiv City Clinical Skin and Venereal Hospital /ID# 218382
Kyiv, Kyivska Oblast, Ukraine
ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385
Rivne, , Ukraine
Victoria Hospital /ID# 213564
Kirkcaldy, Fife, United Kingdom
Duplicate_The Royal Free London NHS Foundation Trust /ID# 213560
London, London, City of, United Kingdom
NHS Greater Glasgow and Clyde /ID# 213561
Glasgow, Scotland, United Kingdom
University Hospitals Sussex NHS Foundation Trust /ID# 213562
Worthing, West Sussex, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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M19-850
Identifier Type: -
Identifier Source: org_study_id
2019-001227-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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