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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05601882
Registration number
NCT05601882
Ethics application status
Date submitted
31/10/2022
Date registered
1/11/2022
Titles & IDs
Public title
A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
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Scientific title
A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)
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Secondary ID [1]
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0
2022-002482-15
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Secondary ID [2]
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M23-696
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Universal Trial Number (UTN)
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Trial acronym
Level Up
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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0
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Condition category
Condition code
Skin
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0
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Inflammatory and Immune System
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0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Dupilumab
Experimental: Upadacitinib - Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.
Experimental: Dupilumab followed by Upadacitinib - Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.
Treatment: Drugs: Upadacitinib
Oral Tablets
Treatment: Drugs: Dupilumab
Subcutaneous Injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1)
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Assessment method [1]
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The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72. The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.
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Timepoint [1]
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At week 16
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Secondary outcome [1]
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Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)
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Assessment method [1]
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The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.
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Timepoint [1]
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Up to week 16
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Secondary outcome [2]
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Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1
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Assessment method [2]
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The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.
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Timepoint [2]
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Up to week 16
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Secondary outcome [3]
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Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) = 4 among those with Baseline WP-NRS = 4
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Assessment method [3]
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The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.
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Timepoint [3]
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At week 16
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Secondary outcome [4]
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Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75)
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Assessment method [4]
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The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.
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Timepoint [4]
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At week 2
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Secondary outcome [5]
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Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100)
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Assessment method [5]
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The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.
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Timepoint [5]
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At week 16
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Eligibility
Key inclusion criteria
* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
* Eczema area and severity index (EASI) score = 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score = 3 and = 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
* Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) = 4.
* Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.
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Minimum age
12
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* History of an organ transplant which requires continued immunosuppression.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/08/2024
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Sample size
Target
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Accrual to date
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Final
926
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Premier Specialist /ID# 250572 - Kogarah
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Recruitment hospital [2]
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Veracity Clinical Research /ID# 249943 - Woolloongabba
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Skin Health Institute Inc /ID# 249938 - Carlton
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Sinclair Dermatology - Melbourne /ID# 249937 - East Melbourne
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Fremantle Dermatology /ID# 249941 - Fremantle
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Recruitment postcode(s) [1]
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2217 - Kogarah
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4102 - Woolloongabba
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3053 - Carlton
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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6160 - Fremantle
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Regiao Autonoma Da Madeira
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Romania
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Romania
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Cluj
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Barcelona
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Alicante
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Granada
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Madrid
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Turkey
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Adana
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Bursa
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Kayseri
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Turkey
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Samsun
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Summary
Brief summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT05601882
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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, analyses plans, 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)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05601882