Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02925117




Registration number
NCT02925117
Ethics application status
Date submitted
4/10/2016
Date registered
5/10/2016

Titles & IDs
Public title
A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis
Scientific title
A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
2016-002451-21
Secondary ID [2] 0 0
M16-048
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
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo once a day for 72 weeks in Period 2.

Experimental: Upadacitinib 7.5 mg - Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Experimental: Upadacitinib 15 mg - Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Experimental: Upadacitinib 30 mg - Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2.


Treatment: Drugs: Upadacitinib
Tablet for oral use

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

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Timepoint [3] 0 0
Baseline and Weeks 2, 8, and 16
Secondary outcome [4] 0 0
Percent Change From Baseline in EASI Score at Week 8
Timepoint [4] 0 0
Baseline and Week 8
Secondary outcome [5] 0 0
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
Timepoint [5] 0 0
Baseline and Weeks 8 and 16
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved an EASI 75 Response at Week 8
Timepoint [6] 0 0
Baseline and Week 8
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
Timepoint [7] 0 0
Baseline and Weeks 8 and 16
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
Timepoint [8] 0 0
Baseline and Weeks 8 and 16
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
Timepoint [9] 0 0
Baseline and Weeks 8 and 16
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
Timepoint [10] 0 0
Baseline and Weeks 8 and 16
Secondary outcome [11] 0 0
Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
Timepoint [11] 0 0
Baseline and Weeks 8 and 16
Secondary outcome [12] 0 0
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Timepoint [12] 0 0
Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Secondary outcome [13] 0 0
Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16
Timepoint [13] 0 0
From re-randomization at Week 16 until Week 88
Secondary outcome [14] 0 0
Percentage of Participants With an EASI 75 Response in Period 2 in Participants Who Were Re-randomized as EASI 75 Non-responders at Week 16
Timepoint [14] 0 0
Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Secondary outcome [15] 0 0
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16
Timepoint [15] 0 0
Weeks 8 and 16
Secondary outcome [16] 0 0
Change From Baseline in DLQI at Weeks 8 and 16
Timepoint [16] 0 0
Baseline and Weeks 8 and 16
Secondary outcome [17] 0 0
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Timepoint [17] 0 0
Baseline and Week 16
Secondary outcome [18] 0 0
Percentage of Participants With Reduction of = 4 Points From Baseline in Pruritus NRS at Week 16
Timepoint [18] 0 0
Baseline and Week 16

Eligibility
Key inclusion criteria
* Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline.
* Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index (EASI) = 16, body surface area (BSA) = 10% and an Investigators Global Assessment (IGA) score = 3 at the Baseline visit.
* Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
* Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).
* Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.
* Prior exposure to dupilumab or exposure to systemic therapies for AD including corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline.
* Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical 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 2
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
25/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2019
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Woden Dermatology /ID# 157907 - Phillip
Recruitment hospital [2] 0 0
St George Hospital /ID# 157908 - Kogarah
Recruitment hospital [3] 0 0
Specialist Connect Pty Ltd /ID# 157909 - Woolloongabba
Recruitment hospital [4] 0 0
Skin Health Institute Inc /ID# 157906 - Carlton
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Finland
State/province [11] 0 0
Varsinais-Suomi
Country [12] 0 0
Finland
State/province [12] 0 0
Mikkeli
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Japan
State/province [14] 0 0
Fukuoka
Country [15] 0 0
Japan
State/province [15] 0 0
Hokkaido
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo
Country [17] 0 0
Netherlands
State/province [17] 0 0
Gelderland
Country [18] 0 0
Netherlands
State/province [18] 0 0
Noord-Holland
Country [19] 0 0
Netherlands
State/province [19] 0 0
Groningen
Country [20] 0 0
Netherlands
State/province [20] 0 0
Utrecht
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona

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 and 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)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Guttman-Yassky E, Thaci D, Pangan AL, Hong HC, Pap... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02925117