Back to resultsOpen-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Upadacitinib, ABT-494, RINVOQ
Eligibility Criteria
Inclusion Criteria:
- Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation 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:
- Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Sites / Locations
- University of Arkansas for Medical Sciences /ID# 221021
- First OC Dermatology Research Inc /ID# 218619
- UCSF Fresno /ID# 218453
- California Allergy and Asthma Medical Group /ID# 218635
- Dermatology Research Associates /ID# 218637
- Dermatology Clinical Trials /ID# 218627
- UC Davis Health /ID# 218582
- Ucsd /Id# 218629
- Clinical Science Institute /ID# 218632
- Miami Dermatology and Laser Institute /ID# 218664
- Florida International Rsrch cr /ID# 218663
- GCP Research /ID# 218665
- Clinical Research Trials of Florida, Inc. /ID# 218438
- Georgia Pollens Clinical Research Centers, Inc /ID# 218441
- Medical Dermatology Associates of Chicago /ID# 218551
- Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552
- Dawes Fretzin, LLC /ID# 218478
- Beacon Clinical Research, LLC /ID# 218636
- Michigan Center for Research Company /ID# 218577
- Henry Ford Medical Center /ID# 218575
- Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548
- Skin Specialists, PC /ID# 218549
- University Hospitals Case Medical Center /ID# 218574
- Southside Dermatology /ID# 218477
- Oregon Medical Res Center PC /ID# 218440
- Oregon Medical Research Center /ID# 218578
- Medical University of South Carolina /ID# 221072
- Clinical Research Solutions, LLC /ID# 218447
- Orion Clinical Research /ID# 218565
- Sante Clinical Research /ID# 218911
- Clinical Research Partners, LLC /ID# 218480
- Premier Clinical Research /ID# 218583
- West Virginia Research Inst /ID# 218479
- Holdsworth House Medical Practice /ID# 218755
- The Skin Hospital /ID# 218753
- Veracity Clinical Research /ID# 218754
- Sinclair Dermatology /ID# 218751
- Burswood Dermatology /ID# 218752
- Kirk Barber Research, CA /ID# 218727
- Dermatology Research Institute Inc. /ID# 218728
- Dr. Chih-ho Hong Medical Inc. /ID# 218725
- Enverus Medical Research /ID# 218726
- Dr. Wei Jing Loo Medicine Prof /ID# 218722
- Lynderm Research Inc. /ID# 218723
- DermEdge Research Inc. /ID# 218721
- North York Research Inc /ID# 218729
- K. Papp Clinical Research /ID# 218730
- Dre Angelique Gagne-Henley M.D. inc. /ID# 218724
- DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377
- Klinicki bolnicki centar Zagreb /ID# 218375
- Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376
- Fakultni nemocnice Hradec Kralove /ID# 214176
- Nemocnice Jihlava, prispevkova organizace /ID# 214178
- Fakultni nemocnice Ostrava /ID# 214177
- Fakultni Nemocnice v Motole /ID# 214179
- Keski-pohjanmaa Central Hospital /ID# 214630
- Oulun yliopistollinen sairaala /ID# 214628
- Mikkeli Central Hospital /ID# 214629
- AP-HM - Hopital de la Timone /ID# 218957
- Polyclinique Courlancy /ID# 218955
- CHU de Nantes, Hotel Dieu -HME /ID# 218959
- Hôpital Charles-Nicolle /ID# 218960
- CHU Toulouse - Hopital Larrey /ID# 218958
- Universitaetsklinikum Frankfurt /ID# 214223
- Universitaetsklinikum Muenster /ID# 214222
- Klinikum Darmstadt /ID# 214224
- Medizinische Hochschule Hannover /ID# 214226
- Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225
- Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221
- Oroshazi Korhaz /ID# 214986
- Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984
- Uno Medical Trials Kft /ID# 214987
- St Vincent's University Hospital /ID# 213558
- The Chaim Sheba Medical Center /ID# 218522
- HaEmek Medical Center /ID# 218520
- Rabin Medical Center /ID# 218521
- Istituto Clinico Humanitas /ID# 215727
- Fondazione PTV Policlinico Tor Vergata /ID# 214093
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095
- Azienda Ospedaliero-Universitaria di Modena /ID# 214096
- Hospital Sultan Ismail /ID# 218881
- Hospital Pakar Sultanah Fatimah /ID# 218877
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879
- Hospital Putrajaya /ID# 218880
- University Malaya Med Ctr /ID# 218882
- Hospital Pulau Pinang /ID# 218878
- Bravis Ziekenhuis /ID# 218772
- Erasmus Medisch Centrum /ID# 218770
- Universitair Medisch Centrum Groningen /ID# 218775
- Universitair Medisch Centrum Utrecht /ID# 218771
- Optimal Clinical Trials Ltd /ID# 218688
- Wellington Regional Hospital /ID# 218689
- Clinical Trials NZ /ID# 218690
- Universitetssykehuset N-Norge, Tromso /ID# 214634
- Dermoklinika Centrum Medyczne s.c. /ID# 214300
- Pratia MCM Krakow /ID# 214303
- Klinika Ambroziak Sp. z o.o. /ID# 214301
- Royalderm Agnieszka Nawrocka /ID# 214302
- ClinicMed Daniluk, Nowak Sp.k. /ID# 214299
- National University Hospital /ID# 219093
- Hospital Universitario de Bellvitge /ID# 214257
- Hospital Universitario Dr. Negrin /ID# 214256
- Hospital de Manises /ID# 214258
- Complejo Hospitalario Universitario de Pontevedra /ID# 214255
- Hospital Universitario Arnau Vilanova /ID# 214254
- Hospital Universitario y Politecnico La Fe /ID# 214252
- Chung Shan Medical University Hospital /ID# 218919
- China Medical University Hospital /ID# 218409
- National Taiwan University Hospital /ID# 218917
- Taipei Municipal Wan Fang Hospital /ID# 218918
- Kyiv City Clinical Skin and Venereal Hospital /ID# 218382
- ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385
- Victoria Hospital /ID# 213564
- The Royal Free London NHS Foundation Trust /ID# 213560
- NHS Greater Glasgow and Clyde /ID# 213561
- University Hospitals Sussex NHS Foundation Trust /ID# 213562
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Upadacitinib
Arm Description
Participants will be administered with upadacitinib once daily (QD)
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04195698
Brief Title
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
Official Title
A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
September 11, 2023 (Actual)
Study Completion Date
September 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Upadacitinib, ABT-494, RINVOQ
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
485 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Upadacitinib
Arm Type
Experimental
Arm Description
Participants will be administered with upadacitinib once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Upadacitinib will be administered oral as tablet
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Time Frame
From Baseline to 30 days following last dose of study drug (Week 52)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation 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:
Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences /ID# 221021
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
First OC Dermatology Research Inc /ID# 218619
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-3701
Country
United States
Facility Name
UCSF Fresno /ID# 218453
City
Fresno
State/Province
California
ZIP/Postal Code
93701-2302
Country
United States
Facility Name
California Allergy and Asthma Medical Group /ID# 218635
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025-7014
Country
United States
Facility Name
Dermatology Research Associates /ID# 218637
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Dermatology Clinical Trials /ID# 218627
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660-7853
Country
United States
Facility Name
UC Davis Health /ID# 218582
City
Sacramento
State/Province
California
ZIP/Postal Code
95816-3300
Country
United States
Facility Name
Ucsd /Id# 218629
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Science Institute /ID# 218632
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404-2102
Country
United States
Facility Name
Miami Dermatology and Laser Institute /ID# 218664
City
Miami
State/Province
Florida
ZIP/Postal Code
33173-3570
Country
United States
Facility Name
Florida International Rsrch cr /ID# 218663
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
GCP Research /ID# 218665
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 218438
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers, Inc /ID# 218441
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707-1282
Country
United States
Facility Name
Medical Dermatology Associates of Chicago /ID# 218551
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654-6903
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 218478
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Beacon Clinical Research, LLC /ID# 218636
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Michigan Center for Research Company /ID# 218577
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Henry Ford Medical Center /ID# 218575
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-3046
Country
United States
Facility Name
Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505-2343
Country
United States
Facility Name
Skin Specialists, PC /ID# 218549
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
University Hospitals Case Medical Center /ID# 218574
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Southside Dermatology /ID# 218477
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74132
Country
United States
Facility Name
Oregon Medical Res Center PC /ID# 218440
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Oregon Medical Research Center /ID# 218578
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Medical University of South Carolina /ID# 221072
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Clinical Research Solutions, LLC /ID# 218447
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305-2163
Country
United States
Facility Name
Orion Clinical Research /ID# 218565
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-4100
Country
United States
Facility Name
Sante Clinical Research /ID# 218911
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028-9640
Country
United States
Facility Name
Clinical Research Partners, LLC /ID# 218480
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220-4459
Country
United States
Facility Name
Premier Clinical Research /ID# 218583
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
West Virginia Research Inst /ID# 218479
City
South Charleston
State/Province
West Virginia
ZIP/Postal Code
25309
Country
United States
Facility Name
Holdsworth House Medical Practice /ID# 218755
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Skin Hospital /ID# 218753
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Veracity Clinical Research /ID# 218754
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Sinclair Dermatology /ID# 218751
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Burswood Dermatology /ID# 218752
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
Kirk Barber Research, CA /ID# 218727
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Dermatology Research Institute Inc. /ID# 218728
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc. /ID# 218725
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research /ID# 218726
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Dr. Wei Jing Loo Medicine Prof /ID# 218722
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc. /ID# 218723
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
DermEdge Research Inc. /ID# 218721
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
North York Research Inc /ID# 218729
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3A6
Country
Canada
Facility Name
K. Papp Clinical Research /ID# 218730
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Dre Angelique Gagne-Henley M.D. inc. /ID# 218724
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 218375
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376
City
Ivanic-Grad
State/Province
Zagrebacka Zupanija
ZIP/Postal Code
10310
Country
Croatia
Facility Name
Fakultni nemocnice Hradec Kralove /ID# 214176
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Nemocnice Jihlava, prispevkova organizace /ID# 214178
City
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava /ID# 214177
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni Nemocnice v Motole /ID# 214179
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Keski-pohjanmaa Central Hospital /ID# 214630
City
Kokkola
State/Province
Keski-Pohjanmaa
ZIP/Postal Code
67200
Country
Finland
Facility Name
Oulun yliopistollinen sairaala /ID# 214628
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Facility Name
Mikkeli Central Hospital /ID# 214629
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
AP-HM - Hopital de la Timone /ID# 218957
City
Marseille CEDEX 05
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Facility Name
Polyclinique Courlancy /ID# 218955
City
Reims
State/Province
Marne
ZIP/Postal Code
51100
Country
France
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 218959
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
Hôpital Charles-Nicolle /ID# 218960
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CHU Toulouse - Hopital Larrey /ID# 218958
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Universitaetsklinikum Frankfurt /ID# 214223
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Muenster /ID# 214222
City
Munster
State/Province
Niedersachsen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum Darmstadt /ID# 214224
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Medizinische Hochschule Hannover /ID# 214226
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Oroshazi Korhaz /ID# 214986
City
Oroshaza
State/Province
Bekes
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Uno Medical Trials Kft /ID# 214987
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
St Vincent's University Hospital /ID# 213558
City
Elm Park
State/Province
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
The Chaim Sheba Medical Center /ID# 218522
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
HaEmek Medical Center /ID# 218520
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Rabin Medical Center /ID# 218521
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Istituto Clinico Humanitas /ID# 215727
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata /ID# 214093
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena /ID# 214096
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Hospital Sultan Ismail /ID# 218881
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
Facility Name
Hospital Pakar Sultanah Fatimah /ID# 218877
City
Muar
State/Province
Johor
ZIP/Postal Code
84000
Country
Malaysia
Facility Name
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Hospital Putrajaya /ID# 218880
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
University Malaya Med Ctr /ID# 218882
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Pulau Pinang /ID# 218878
City
Penang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
Bravis Ziekenhuis /ID# 218772
City
Bergen op Zoom
State/Province
Noord-Brabant
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Name
Erasmus Medisch Centrum /ID# 218770
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 218775
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 218771
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Optimal Clinical Trials Ltd /ID# 218688
City
Grafotn
State/Province
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Wellington Regional Hospital /ID# 218689
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Clinical Trials NZ /ID# 218690
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Universitetssykehuset N-Norge, Tromso /ID# 214634
City
Tromso
State/Province
Troms
ZIP/Postal Code
9019
Country
Norway
Facility Name
Dermoklinika Centrum Medyczne s.c. /ID# 214300
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Pratia MCM Krakow /ID# 214303
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-727
Country
Poland
Facility Name
Klinika Ambroziak Sp. z o.o. /ID# 214301
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka /ID# 214302
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp.k. /ID# 214299
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
National University Hospital /ID# 219093
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Hospital Universitario de Bellvitge /ID# 214257
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Dr. Negrin /ID# 214256
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain
Facility Name
Hospital de Manises /ID# 214258
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Pontevedra /ID# 214255
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario Arnau Vilanova /ID# 214254
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 214252
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Chung Shan Medical University Hospital /ID# 218919
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 218409
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 218917
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Municipal Wan Fang Hospital /ID# 218918
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
Kyiv City Clinical Skin and Venereal Hospital /ID# 218382
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385
City
Rivne
ZIP/Postal Code
33028
Country
Ukraine
Facility Name
Victoria Hospital /ID# 213564
City
Kirkcaldy
State/Province
Fife
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Facility Name
The Royal Free London NHS Foundation Trust /ID# 213560
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde /ID# 213561
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
University Hospitals Sussex NHS Foundation Trust /ID# 213562
City
Worthing
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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, analyses plans, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
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