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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03334422




Registration number
NCT03334422
Ethics application status
Date submitted
3/11/2017
Date registered
7/11/2017

Titles & IDs
Public title
Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Patients With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
I4V-MC-JAHM
Secondary ID [2] 0 0
16581
Universal Trial Number (UTN)
Trial acronym
BREEZE-AD2
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 - Baricitinib
Treatment: Drugs - Placebo

Experimental: 4 Milligram (mg) Baricitinib - 4mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match

Experimental: 2mg Baricitinib - 2mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.

Experimental: 1mg Baricitinib - 1mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.

Placebo comparator: Placebo - Placebo administered orally once daily.


Treatment: Drugs: Baricitinib
Administered orally

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a = 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib)
Timepoint [1] 0 0
16 Weeks
Secondary outcome [1] 0 0
Percentage of Participants Achieving IGA of 0 or 1 With a = 2 Point Improvement (Placebo, 1mg Baricitinib)
Timepoint [1] 0 0
16 Weeks
Secondary outcome [2] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
Timepoint [2] 0 0
16 Weeks
Secondary outcome [3] 0 0
Percentage of Participants Achieving EASI90
Timepoint [3] 0 0
16 Weeks
Secondary outcome [4] 0 0
Percent Change From Baseline on EASI Score
Timepoint [4] 0 0
Baseline, 16 Weeks
Secondary outcome [5] 0 0
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
Timepoint [5] 0 0
16 Weeks
Secondary outcome [6] 0 0
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
Timepoint [6] 0 0
16 Weeks
Secondary outcome [7] 0 0
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
Timepoint [7] 0 0
Baseline, 16 Weeks
Secondary outcome [8] 0 0
Change From Baseline in Skin Pain NRS
Timepoint [8] 0 0
Baseline, 16 Weeks
Secondary outcome [9] 0 0
Percentage of Participants Achieving EASI50
Timepoint [9] 0 0
16 Weeks
Secondary outcome [10] 0 0
Percentage of Participants Achieving IGA of 0
Timepoint [10] 0 0
16 Weeks
Secondary outcome [11] 0 0
Change From Baseline in SCORAD
Timepoint [11] 0 0
Baseline, 16 Weeks
Secondary outcome [12] 0 0
Percentage of Participants Achieving SCORAD90
Timepoint [12] 0 0
16 Weeks
Secondary outcome [13] 0 0
Change From Baseline in Body Surface Area (BSA) Affected
Timepoint [13] 0 0
Baseline, 16 Weeks
Secondary outcome [14] 0 0
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
Timepoint [14] 0 0
16 Weeks
Secondary outcome [15] 0 0
Percent Change From Baseline in Itch NRS
Timepoint [15] 0 0
Baseline, 16 Weeks
Secondary outcome [16] 0 0
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
Timepoint [16] 0 0
Baseline, 16 Weeks
Secondary outcome [17] 0 0
Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score
Timepoint [17] 0 0
Baseline, 16 Weeks
Secondary outcome [18] 0 0
Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [18] 0 0
Baseline, 16 Weeks
Secondary outcome [19] 0 0
Change From Baseline on the Dermatology Life Quality Index (DLQI)
Timepoint [19] 0 0
Baseline, 16 Weeks
Secondary outcome [20] 0 0
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Timepoint [20] 0 0
Baseline, 16 Weeks
Secondary outcome [21] 0 0
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
Timepoint [21] 0 0
Baseline, 16 Weeks
Secondary outcome [22] 0 0
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
Timepoint [22] 0 0
Baseline, 16 Weeks
Secondary outcome [23] 0 0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a = 2 Point Improvement
Timepoint [23] 0 0
4 Weeks

Eligibility
Key inclusion criteria
* Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
* Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
* Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
* Agree to use emollients daily.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
* A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
* Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
* Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
* Have been treated with the following therapies:

* Monoclonal antibody for less than 5 half-lives prior to randomization.
* Received prior treatment with any oral Janus kinase (JAK) inhibitor.
* Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
* Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
* Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
* Have had major surgery within the past eight weeks or are planning major surgery during the study.
* Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
* Have a history of recurrent (= 2) VTE or are considered at high risk of VTE as deemed by the investigator.
* Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
* Have specific laboratory abnormalities.
* Have received certain treatments that are contraindicated.
* Pregnant or breastfeeding.

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 analysing the results/data
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
27/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2018
Sample size
Target
Accrual to date
Final
615
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Skin & Cancer Foundation Australia - Westmead
Recruitment hospital [3] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [4] 0 0
Clinical Trials SA Pty Ltd - Adelaide
Recruitment hospital [5] 0 0
Skin and Cancer Foundation Inc. - Carlton
Recruitment hospital [6] 0 0
Fremantle Dermatology - Perth
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5073 - Adelaide
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
6160 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Mendoza
Country [4] 0 0
Austria
State/province [4] 0 0
Oberösterreich
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Hungary
State/province [6] 0 0
Csongrad
Country [7] 0 0
Hungary
State/province [7] 0 0
Hajdu-Bihar
Country [8] 0 0
Hungary
State/province [8] 0 0
Jasz-Nagykun-Szolnok
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Hungary
State/province [10] 0 0
Kaposvar
Country [11] 0 0
Hungary
State/province [11] 0 0
Oroshaza
Country [12] 0 0
Hungary
State/province [12] 0 0
Szombathely
Country [13] 0 0
Hungary
State/province [13] 0 0
Veszprem
Country [14] 0 0
Israel
State/province [14] 0 0
Afula
Country [15] 0 0
Israel
State/province [15] 0 0
Haifa
Country [16] 0 0
Israel
State/province [16] 0 0
Jerusalem
Country [17] 0 0
Israel
State/province [17] 0 0
Petach Tikva
Country [18] 0 0
Israel
State/province [18] 0 0
Ramat Gan
Country [19] 0 0
Israel
State/province [19] 0 0
Tel Aviv
Country [20] 0 0
Japan
State/province [20] 0 0
Chiba
Country [21] 0 0
Japan
State/province [21] 0 0
Fukuoka
Country [22] 0 0
Japan
State/province [22] 0 0
Hokkaido
Country [23] 0 0
Japan
State/province [23] 0 0
Ibaraki
Country [24] 0 0
Japan
State/province [24] 0 0
Kanagawa
Country [25] 0 0
Japan
State/province [25] 0 0
Kumamoto
Country [26] 0 0
Japan
State/province [26] 0 0
Osaka
Country [27] 0 0
Japan
State/province [27] 0 0
Saitama
Country [28] 0 0
Japan
State/province [28] 0 0
Tochigi
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Japan
State/province [30] 0 0
Gifu
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Gyeonggi Do
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Korea
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Poland
State/province [34] 0 0
Bialystok
Country [35] 0 0
Poland
State/province [35] 0 0
Gdansk
Country [36] 0 0
Poland
State/province [36] 0 0
Katowice
Country [37] 0 0
Poland
State/province [37] 0 0
Krakow
Country [38] 0 0
Poland
State/province [38] 0 0
Lodz
Country [39] 0 0
Poland
State/province [39] 0 0
Olsztyn
Country [40] 0 0
Poland
State/province [40] 0 0
Osielsko
Country [41] 0 0
Poland
State/province [41] 0 0
Szczecin
Country [42] 0 0
Poland
State/province [42] 0 0
Warsaw
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Spain
State/province [44] 0 0
Badalona
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Navarra
Country [47] 0 0
Spain
State/province [47] 0 0
Alicante
Country [48] 0 0
Spain
State/province [48] 0 0
Pontevedra
Country [49] 0 0
Switzerland
State/province [49] 0 0
Vaud
Country [50] 0 0
Switzerland
State/province [50] 0 0
Bern
Country [51] 0 0
Switzerland
State/province [51] 0 0
Genève
Country [52] 0 0
Switzerland
State/province [52] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Incyte Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
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?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03334422