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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04195698
Ethics application status
Date submitted
2/12/2019
Date registered
12/12/2019
Date last updated
8/10/2020

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(has expanded access)
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 - 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.
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
Gender
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
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Skin Hospital /ID# 218753 - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice /ID# 218755 - Sydney
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
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 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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Oklahoma
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South Carolina
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Tennessee
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Texas
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Ontario
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Quebec
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Croatia
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Grad Zagreb
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Croatia
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Zagrebacka Zupanija
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Praha 5
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Hradec Kralove
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Jihlava
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Keski-Pohjanmaa
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Finland
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Pohjois-Pohjanmaa
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Finland
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Mikkeli
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Putrajaya
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Lodz
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Kyiv
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Rivne
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Glasgow City
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London, City Of

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04195698
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04195698