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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03568318
Ethics application status
Date submitted
14/06/2018
Date registered
26/06/2018

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 - Placebo
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Topical corticosteroids (TCS)

Placebo comparator: Placebo / Upadacitinib + Topical Corticosteroids - Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Experimental: Upadacitinib 15 mg QD + Topical Corticosteroids - Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Experimental: Upadacitinib 30 mg QD + Topical Corticosteroids - Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Experimental: Long-Term Extension - Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.


Treatment: Drugs: Placebo
Tablets taken orally once a day

Treatment: Drugs: Upadacitinib
Tablets taken orally once a day

Treatment: Drugs: Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.

Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Primary outcome [2] 0 0
Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of = 2 Points at Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16
Timepoint [1] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [2] 0 0
Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 4
Timepoint [3] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 4
Secondary outcome [4] 0 0
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4
Timepoint [4] 0 0
Baseline and Week 4
Secondary outcome [5] 0 0
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2
Timepoint [5] 0 0
Baseline and Week 2
Secondary outcome [6] 0 0
Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4
Timepoint [6] 0 0
Baseline and Week 4
Secondary outcome [7] 0 0
Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1
Timepoint [8] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 1
Secondary outcome [9] 0 0
Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16
Timepoint [9] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [10] 0 0
Main Study: Percent Change From Baseline in EASI Score at Week 16
Timepoint [10] 0 0
Baseline and Week 16
Secondary outcome [11] 0 0
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16
Timepoint [11] 0 0
Baseline and Week 16
Secondary outcome [12] 0 0
Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of = 2 Points at Week 16
Timepoint [12] 0 0
Baseline and Week 16
Secondary outcome [13] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 16
Timepoint [13] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [14] 0 0
Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16
Timepoint [14] 0 0
Baseline and Week 16
Secondary outcome [15] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 4
Timepoint [15] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 4
Secondary outcome [16] 0 0
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4
Timepoint [16] 0 0
Baseline and Week 4
Secondary outcome [17] 0 0
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2
Timepoint [17] 0 0
Baseline and Week 2
Secondary outcome [18] 0 0
Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4
Timepoint [18] 0 0
Baseline and Week 4
Secondary outcome [19] 0 0
Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
Timepoint [19] 0 0
Baseline and Week 16
Secondary outcome [20] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1
Timepoint [20] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 1
Secondary outcome [21] 0 0
Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16
Timepoint [21] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [22] 0 0
Adolescents: Percent Change From Baseline in EASI Score at Week 16
Timepoint [22] 0 0
Baseline and Week 16

Eligibility
Key inclusion criteria
* Body weight of = 40 kg at Baseline Visit for participants = 12 and < 18 years of age
* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
* Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) = 16, validated Investigator's Global Assessment (vIGA) = 3, = 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) = 4.
* Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
* 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
Sex
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
9/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/11/2030
Actual
Sample size
Target
1500
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 - St 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 - St 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
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 and 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)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


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/NCT03568318