Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04195698




Registration number
NCT04195698
Ethics application status
Date submitted
2/12/2019
Date registered
12/12/2019

Titles & IDs
Public title
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
2019-001227-12
Secondary ID [2] 0 0
M19-850
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib

Experimental: Upadacitinib - Participants will be administered with upadacitinib once daily (QD)


Treatment: Drugs: Upadacitinib
Upadacitinib will be administered oral as tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events
Timepoint [1] 0 0
UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).
Primary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Timepoint [2] 0 0
UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).
Primary outcome [3] 0 0
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Timepoint [3] 0 0
From Baseline to 30 days following last dose of study drug (Week 52)
Primary outcome [4] 0 0
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Timepoint [4] 0 0
From Baseline to 30 days following last dose of study drug (Week 52)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/09/2023
Sample size
Target
Accrual to date
Final
475
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice /ID# 218755 - Darlinghurst
Recruitment hospital [2] 0 0
The Skin Hospital /ID# 218753 - Darlinghurst
Recruitment hospital [3] 0 0
Veracity Clinical Research /ID# 218754 - Woolloongabba
Recruitment hospital [4] 0 0
Sinclair Dermatology - Melbourne /ID# 218751 - East Melbourne
Recruitment hospital [5] 0 0
Burswood Dermatology /ID# 218752 - Victoria Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
West Virginia
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Croatia
State/province [23] 0 0
Grad Zagreb
Country [24] 0 0
Croatia
State/province [24] 0 0
Zagrebacka Zupanija
Country [25] 0 0
Czechia
State/province [25] 0 0
Hradec Kralove
Country [26] 0 0
Czechia
State/province [26] 0 0
Jihlava
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostrava
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha
Country [29] 0 0
Finland
State/province [29] 0 0
Keski-Pohjanmaa
Country [30] 0 0
Finland
State/province [30] 0 0
Pohjois-Pohjanmaa
Country [31] 0 0
Finland
State/province [31] 0 0
Mikkeli
Country [32] 0 0
France
State/province [32] 0 0
Bouches-du-Rhone
Country [33] 0 0
France
State/province [33] 0 0
Marne
Country [34] 0 0
France
State/province [34] 0 0
Pays-de-la-Loire
Country [35] 0 0
France
State/province [35] 0 0
Rouen
Country [36] 0 0
France
State/province [36] 0 0
Toulouse
Country [37] 0 0
Germany
State/province [37] 0 0
Brandenburg
Country [38] 0 0
Germany
State/province [38] 0 0
Hessen
Country [39] 0 0
Germany
State/province [39] 0 0
Niedersachsen
Country [40] 0 0
Germany
State/province [40] 0 0
Hannover
Country [41] 0 0
Germany
State/province [41] 0 0
Munich
Country [42] 0 0
Hungary
State/province [42] 0 0
Bekes
Country [43] 0 0
Hungary
State/province [43] 0 0
Somogy
Country [44] 0 0
Hungary
State/province [44] 0 0
Budapest
Country [45] 0 0
Ireland
State/province [45] 0 0
Dublin
Country [46] 0 0
Israel
State/province [46] 0 0
HaDarom
Country [47] 0 0
Israel
State/province [47] 0 0
Tel-Aviv
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Italy
State/province [49] 0 0
Milano
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Italy
State/province [51] 0 0
Milan
Country [52] 0 0
Italy
State/province [52] 0 0
Modena
Country [53] 0 0
Malaysia
State/province [53] 0 0
Johor
Country [54] 0 0
Malaysia
State/province [54] 0 0
Selangor
Country [55] 0 0
Malaysia
State/province [55] 0 0
Wilayah Persekutuan Putrajaya
Country [56] 0 0
Malaysia
State/province [56] 0 0
Kuala Lumpur
Country [57] 0 0
Malaysia
State/province [57] 0 0
Penang
Country [58] 0 0
Netherlands
State/province [58] 0 0
Noord-Brabant
Country [59] 0 0
Netherlands
State/province [59] 0 0
Zuid-Holland
Country [60] 0 0
Netherlands
State/province [60] 0 0
Groningen
Country [61] 0 0
Netherlands
State/province [61] 0 0
Utrecht
Country [62] 0 0
New Zealand
State/province [62] 0 0
Auckland
Country [63] 0 0
New Zealand
State/province [63] 0 0
Wellington
Country [64] 0 0
New Zealand
State/province [64] 0 0
Hamilton
Country [65] 0 0
Norway
State/province [65] 0 0
Troms
Country [66] 0 0
Poland
State/province [66] 0 0
Lodzkie
Country [67] 0 0
Poland
State/province [67] 0 0
Malopolskie
Country [68] 0 0
Poland
State/province [68] 0 0
Mazowieckie
Country [69] 0 0
Poland
State/province [69] 0 0
Podlaskie
Country [70] 0 0
Singapore
State/province [70] 0 0
Singapore
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Las Palmas
Country [73] 0 0
Spain
State/province [73] 0 0
Valencia
Country [74] 0 0
Spain
State/province [74] 0 0
Pontevedra
Country [75] 0 0
Taiwan
State/province [75] 0 0
Taipei
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taichung
Country [77] 0 0
Ukraine
State/province [77] 0 0
Kyivska Oblast
Country [78] 0 0
Ukraine
State/province [78] 0 0
Rivne
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Fife
Country [80] 0 0
United Kingdom
State/province [80] 0 0
London, City Of
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Scotland
Country [82] 0 0
United Kingdom
State/province [82] 0 0
West Sussex

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04195698