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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05601882




Registration number
NCT05601882
Ethics application status
Date submitted
31/10/2022
Date registered
1/11/2022
Date last updated
21/05/2024

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
Active, not recruiting
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
9/07/2024
Actual
Sample size
Target
880
Accrual to date
Final
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
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4102 - Woolloongabba
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3053 - Carlton
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3002 - East Melbourne
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6160 - Fremantle
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05601882
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