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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 Adverse Events
Timepoint [1] 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
485
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 /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
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United States of America
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Arkansas
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California
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Florida
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Georgia
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Indiana
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Massachusetts
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Michigan
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Nebraska
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Ohio
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Quebec
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Grad Zagreb
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Hradec Kralove
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Hessen
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Israel
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Rivne
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Fife
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London, City Of
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Scotland
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United Kingdom
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Worthing

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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04195698