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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03568318




Registration number
NCT03568318
Ethics application status
Date submitted
14/06/2018
Date registered
26/06/2018
Date last updated
29/06/2020

Titles & IDs
Public title
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Scientific title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
2017-005126-37
Secondary ID [2] 0 0
M16-047
Universal Trial Number (UTN)
Trial acronym
AD Up
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
Treatment: Drugs - Placebo for Upadacitinib
Treatment: Drugs - Topical corticosteroids (TCS)

Experimental: Arm A - Upadacitinib Dose A is administered once daily along with Topical corticosteroids (TCS).

Experimental: Arm B - Upadacitinib Dose B is administered once daily along with Topical corticosteroids (TCS).

Experimental: Arm C - Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.

Experimental: Arm D - Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.


Treatment: Drugs: Upadacitinib
It is administered orally.

Treatment: Drugs: Placebo for Upadacitinib
It is administered orally.

Treatment: Drugs: Topical corticosteroids (TCS)
It is administered concomitantly with Upadacitinib or Placebo.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline - The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Timepoint [1] 0 0
At Week 16
Primary outcome [2] 0 0
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two Grades of Reduction from Baseline - The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Timepoint [2] 0 0
At Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 for Participants with Worst Pruritus NRS = 4 at Baseline - The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
Timepoint [1] 0 0
Up to Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving EASI 90 - The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
Timepoint [2] 0 0
Up to Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving EASI 75 - The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
Timepoint [3] 0 0
Up to Week 4
Secondary outcome [4] 0 0
Percentage of Participants in Arm A and Arm C Achieving EASI 100 - The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
Timepoint [4] 0 0
At Week 16

Eligibility
Key inclusion criteria
- Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years
of age

- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline Visit

- Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index
(EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus

- Candidate for systemic therapy or have recently required systemic therapy for atopic
dermatitis

- Documented history of inadequate response to topical corticosteroids or topical
calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to
Baseline Visit
Minimum age
12 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior exposure to any Janus kinase (JAK) inhibitor

- Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to
the study

- Requirement of prohibited medications during the study

- Other active skin diseases or skin infections requiring systemic treatment or would
interfere with appropriate assessment of atopic dermatitis lesions

- Female subject who is pregnant, breastfeeding, or considering pregnancy during the
study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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,WA
Recruitment hospital [1] 0 0
St George Dermatology & Skin Cancer Centre /ID# 204788 - Kogarah
Recruitment hospital [2] 0 0
Royal North Shore Hospital /ID# 204639 - Saint Leonards
Recruitment hospital [3] 0 0
Westmead Hospital /ID# 205682 - Westmead
Recruitment hospital [4] 0 0
Veracity Clinical Research /ID# 204793 - Woolloongabba
Recruitment hospital [5] 0 0
Fremantle Dermatology /ID# 205306 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to assess the efficacy and safety of upadacitinib combined
with topical corticosteroids (TCS) for the treatment of adolescent and adult participants
with moderate to severe Atopic dermatitis (AD) who are candidates for systemic therapy.
Trial website
https://clinicaltrials.gov/show/NCT03568318
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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03568318