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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03607422
Ethics application status
Date submitted
25/07/2018
Date registered
31/07/2018
Date last updated
30/06/2020

Titles & IDs
Public title
A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects 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
2018-001383-28
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 - Upadacitinib
Treatment: Drugs - Placebo for Upadacitinib

Experimental: Arm A - Upadacitinib Dose A is administered once daily.

Experimental: Arm B - Upadacitinib Dose B is administered once daily.

Experimental: Arm C - Placebo administered once daily followed by Upadacitinib Dose A once daily.

Experimental: Arm D - Placebo administered once daily followed by Upadacitinib Dose B once daily.


Treatment: Drugs: Upadacitinib
Oral; Tablet

Treatment: Drugs: Placebo for Upadacitinib
Oral; Tablet

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 from Baseline 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
At 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
At Week 2
Secondary outcome [4] 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 and Randomized to Dose A - 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 [4] 0 0
At Day 2
Secondary outcome [5] 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 and Randomized to Dose B - 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 [5] 0 0
At Day 3
Secondary outcome [6] 0 0
Percentage of Participants Experiencing a Flare - Defined as clinically meaningful worsening in EASI.
Timepoint [6] 0 0
Up to Week 16
Secondary outcome [7] 0 0
Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score = 12 (Minimal Clinically Important Difference (MCID)) from Baseline - This is assessed for participants with ADerm-IS sleep domain score = 12 (MCID) at baseline.
Timepoint [7] 0 0
At Week 16
Secondary outcome [8] 0 0
Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score = 4 (MCID) from Baseline - This is assessed for participants with ADerm-SS skin pain score = 4 (MCID) at baseline.
Timepoint [8] 0 0
At Week 16
Secondary outcome [9] 0 0
Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) 7-item Total Symptom Score (TSS-7) = 28 (MCID) from Baseline - This is assessed for participants with ADerm-SS TSS-7 total score = 28 (MCID) at baseline.
Timepoint [9] 0 0
At Week 16
Secondary outcome [10] 0 0
Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Emotional State Domain score = 11 (MCID) from Baseline - This is assessed for participants with ADerm-IS emotional state domain score = 11 (MCID) at baseline.
Timepoint [10] 0 0
At Week 16
Secondary outcome [11] 0 0
Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Daily Activities Score = 14 (MCID) from Baseline - This is assessed for participants with ADerm-IS daily activity score = 14 (MCID) at baseline.
Timepoint [11] 0 0
At Week 16
Secondary outcome [12] 0 0
Percentage of Participants 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 [12] 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

- Active moderate to severe AD 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 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
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 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,VIC
Recruitment hospital [1] 0 0
The Skin Hospital - Westmead /ID# 217846 - Westmead
Recruitment hospital [2] 0 0
The Skin Centre /ID# 205922 - Benowa
Recruitment hospital [3] 0 0
Monash Health/Monash Children's Hospital /ID# 217917 - Clayton
Recruitment hospital [4] 0 0
Sinclair Dermatology /ID# 217791 - East Melbourne
Recruitment hospital [5] 0 0
Box Hill Hospital /ID# 206023 - Melbourne
Recruitment hospital [6] 0 0
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
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3128 - 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
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Southampton

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 for the
treatment of adolescent and adult participants with moderate to severe AD who are candidates
for systemic therapy.
Trial website
https://clinicaltrials.gov/show/NCT03607422
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/NCT03607422