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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
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)
Secondary ID [1] 0 0
2022-002482-15
Secondary ID [2] 0 0
M23-696
Universal Trial Number (UTN)
Trial acronym
Level 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
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
At week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)
Timepoint [1] 0 0
Up to week 16
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) = 4 among those with Baseline WP-NRS = 4
Timepoint [3] 0 0
At week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75)
Timepoint [4] 0 0
At week 2
Secondary outcome [5] 0 0
Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100)
Timepoint [5] 0 0
At week 16

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.
Minimum age
12 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/08/2024
Sample size
Target
Accrual to date
Final
926
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Premier Specialist /ID# 250572 - Kogarah
Recruitment hospital [2] 0 0
Veracity Clinical Research /ID# 249943 - Woolloongabba
Recruitment hospital [3] 0 0
Skin Health Institute Inc /ID# 249938 - Carlton
Recruitment hospital [4] 0 0
Sinclair Dermatology - Melbourne /ID# 249937 - East Melbourne
Recruitment hospital [5] 0 0
Fremantle Dermatology /ID# 249941 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment outside Australia
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Samsun

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, 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)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
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?

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