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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03738397




Registration number
NCT03738397
Ethics application status
Date submitted
9/11/2018
Date registered
12/11/2018
Date last updated
13/08/2019

Titles & IDs
Public title
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Scientific title
A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
2018-002264-57
Secondary ID [2] 0 0
M16-046
Universal Trial Number (UTN)
Trial acronym
Heads 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 (ABT-494)
Treatment: Drugs - Dupilumab
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: Participants administered with upadacitinib - Participants are administered with upadacitinib from baseline to week 24 and placebo pre-filled syringe at baseline visit (2 injections) followed by an injection every other week until week 22

Experimental: Participants administered with dupilumab - Participants are administered with dupilumab (2 injections) at baseline followed by one every other week until week 22 and placebo tablets daily from baseline to week 24


Treatment: Drugs: Upadacitinib (ABT-494)
Upadacitinib is administered orally

Treatment: Drugs: Dupilumab
Dupilumab is administered as a subcutaneous (SC) injection

Treatment: Drugs: Placebo
Placebo pre-filled syringe is as administered subcutaneous (SC) injections

Treatment: Drugs: Placebo
Placebo tablets are administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants achieving a 75% reduction in Eczema Area and Severity Index (EASI) (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
Secondary outcome [1] 0 0
Percent change in worst pruritus numerical rating scale (NRS) - 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
From Baseline (Week 0) to Week 16
Secondary outcome [2] 0 0
Percentage of participants achieving a 100% reduction in EASI (EASI 100) - 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 a 90% reduction in EASI (EASI 90) - 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 16

Eligibility
Key inclusion criteria
- Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema
Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface
Area (BSA) and pruritus.

- Participant is a candidate for systemic therapy or have recently required systemic
therapy for AD.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has prior exposure to Janus Kinase (JAK) inhibitor.

- Participant has prior exposure to dupilumab.

- Participant is unable or unwilling to discontinue current AD treatments prior to the
study.

- Participant has requirement of prohibited medications during the study.

- Participant has other active skin diseases or skin infections requiring systemic
treatment or would interfere with appropriate assessment of AD lesions.

- Female participant 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,VIC
Recruitment hospital [1] 0 0
The Skin Hospital /ID# 214401 - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice /ID# 214565 - Sydney
Recruitment hospital [3] 0 0
Sinclair Dermatology /ID# 209395 - East Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 3, randomized, multi-center study that will evaluate upadacitinib versus
dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who
are candidates for systemic therapy. The study is comprised of a 35-day screening period, a
24-week blinded treatment period, and a 12-week follow-up period.
Trial website
https://clinicaltrials.gov/show/NCT03738397
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/NCT03738397