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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03607422




Registration number
NCT03607422
Ethics application status
Date submitted
25/07/2018
Date registered
31/07/2018

Titles & IDs
Public title
A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
Scientific title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
2022-502936-38-00
Secondary ID [2] 0 0
M18-891
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 - Placebo for Upadacitinib
Treatment: Drugs - Upadacitinib

Placebo comparator: Placebo / Upadacitinib - 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.

Experimental: Upadacitinib 15 mg QD - Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Experimental: Upadacitinib 30 mg QD - Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.


Treatment: Drugs: Placebo for Upadacitinib
Tablets taken orally once a day

Treatment: Drugs: Upadacitinib
Tablets taken orally once a day
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 2
Timepoint [4] 0 0
Baseline and Week 2
Secondary outcome [5] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1
Timepoint [5] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 1
Secondary outcome [6] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 2
Timepoint [6] 0 0
Baseline and Day 2
Secondary outcome [7] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 3
Timepoint [7] 0 0
Baseline and Day 3
Secondary outcome [8] 0 0
Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
Timepoint [8] 0 0
From first dose of study drug to Week 16
Secondary outcome [9] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score 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: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16
Timepoint [10] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [11] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16
Timepoint [11] 0 0
Baseline and Week 16
Secondary outcome [12] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
Timepoint [12] 0 0
Baseline and Week 16
Secondary outcome [13] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16
Timepoint [13] 0 0
Baseline and Week 16
Secondary outcome [14] 0 0
Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
Timepoint [14] 0 0
Baseline and Week 16
Secondary outcome [15] 0 0
Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16
Timepoint [15] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [16] 0 0
Main Study: Percent Change From Baseline in EASI Score at Week 16
Timepoint [16] 0 0
Baseline and Week 16
Secondary outcome [17] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16
Timepoint [17] 0 0
Baseline and Week 16
Secondary outcome [18] 0 0
Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Timepoint [18] 0 0
Baseline and Week 16
Secondary outcome [19] 0 0
Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
Timepoint [19] 0 0
Baseline and Week 16
Secondary outcome [20] 0 0
Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16
Timepoint [20] 0 0
Week 16
Secondary outcome [21] 0 0
Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
Timepoint [21] 0 0
Week 16
Secondary outcome [22] 0 0
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16
Timepoint [22] 0 0
Baseline and Week 16
Secondary outcome [23] 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 [23] 0 0
Baseline and Week 16
Secondary outcome [24] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 16
Timepoint [24] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [25] 0 0
Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16
Timepoint [25] 0 0
Baseline and Week 16
Secondary outcome [26] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 4
Timepoint [26] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 4
Secondary outcome [27] 0 0
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2
Timepoint [27] 0 0
Baseline and Week 2
Secondary outcome [28] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1
Timepoint [28] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 1
Secondary outcome [29] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 2
Timepoint [29] 0 0
Baseline and Day 2
Secondary outcome [30] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 3
Timepoint [30] 0 0
Baseline and Day 3
Secondary outcome [31] 0 0
Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
Timepoint [31] 0 0
From first dose of study drug to Week 16
Secondary outcome [32] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16
Timepoint [32] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [33] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16
Timepoint [33] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [34] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 28 Points From Baseline in ADerm-SS TSS-7 at Week 16
Timepoint [34] 0 0
Baseline and Week 16
Secondary outcome [35] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
Timepoint [35] 0 0
Baseline and Week 16
Secondary outcome [36] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16
Timepoint [36] 0 0
Baseline and Week 16
Secondary outcome [37] 0 0
Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
Timepoint [37] 0 0
Baseline and Week 16
Secondary outcome [38] 0 0
Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16
Timepoint [38] 0 0
Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary outcome [39] 0 0
Adolescents: Percent Change From Baseline in EASI Score at Week 16
Timepoint [39] 0 0
Baseline and Week 16
Secondary outcome [40] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in POEM Total Score at Week 16
Timepoint [40] 0 0
Baseline and Week 16
Secondary outcome [41] 0 0
Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in DLQI Score at Week 16
Timepoint [41] 0 0
Baseline and Week 16
Secondary outcome [42] 0 0
Adolescents: Percent Change From Baseline in SCORAD Score at Week 16
Timepoint [42] 0 0
Baseline and Week 16
Secondary outcome [43] 0 0
Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16
Timepoint [43] 0 0
Week 16
Secondary outcome [44] 0 0
Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
Timepoint [44] 0 0
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 and subject meets Hanifin and Rajka criteria
* Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) = 16, validated Investigator's Global Assessment (vIGA) = 3, body surface area (BSA) affected by AD = 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score = 4.
* Candidate for systemic therapy or have recently required systemic therapy for AD
* Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks
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 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/12/2025
Actual
Sample size
Target
Accrual to date
Final
912
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The Skin Hospital /ID# 217846 - Westmead
Recruitment hospital [2] 0 0
The Skin Centre /ID# 205922 - Benowa
Recruitment hospital [3] 0 0
Box Hill Hospital /ID# 206023 - Box Hill
Recruitment hospital [4] 0 0
Monash Children's Hospital /ID# 217917 - Clayton
Recruitment hospital [5] 0 0
Sinclair Dermatology /ID# 217791 - East Melbourne
Recruitment hospital [6] 0 0
The Royal Melbourne Hospital /ID# 205919 - Parkville
Recruitment hospital [7] 0 0
Murdoch Children's Research Institute /ID# 205667 - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment outside Australia
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Plymouth

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)?
For details on when studies are available for sharing, please refer to the link below.
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 Use Agreement (DUA). 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://vivli.org/ourmember/abbvie/


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/NCT03607422