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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03733301




Registration number
NCT03733301
Ethics application status
Date submitted
30/10/2018
Date registered
7/11/2018

Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults 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 Combination With Topical Corticosteroids in Adult Patients With Moderate to Severe Atopic Dermatitis BREEZE-AD7
Secondary ID [1] 0 0
I4V-MC-JAIY
Secondary ID [2] 0 0
17100
Universal Trial Number (UTN)
Trial acronym
BREEZE-AD7
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 - Topical corticosteroid
Treatment: Drugs - Placebo

Experimental: 4 Milligram (mg) Baricitinib - 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids (TCS). Placebo administered orally once daily to match 2 mg Baricitinib.

Experimental: 2 mg Baricitinib - 2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib.

Placebo comparator: Placebo - Placebo administered orally once daily in combination with TCS.


Treatment: Drugs: Baricitinib
Administered orally.

Treatment: Drugs: Topical corticosteroid
Administered as standard-of-care.

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
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving EASI90
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percent Change From Baseline on EASI Score
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Change From Baseline in Skin Pain NRS
Timepoint [7] 0 0
Baseline, Week 16
Secondary outcome [8] 0 0
Percentage of Participants Achieving EASI50
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Percentage of Participants Achieving IGA of 0
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change From Baseline in SCORAD
Timepoint [10] 0 0
Baseline, Week 16
Secondary outcome [11] 0 0
Percentage of Participants Achieving SCORAD90
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Change From Baseline in Body Surface Area (BSA) Affected
Timepoint [12] 0 0
Baseline, Week 16
Secondary outcome [13] 0 0
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
Mean Gram Quantity of Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)
Timepoint [14] 0 0
Week 0 through Week 16
Secondary outcome [15] 0 0
Percent Change From Baseline in Itch NRS
Timepoint [15] 0 0
Baseline, Week 16
Secondary outcome [16] 0 0
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
Timepoint [16] 0 0
Baseline, Week 16
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, Week 16
Secondary outcome [18] 0 0
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
Timepoint [18] 0 0
Baseline, Week 16
Secondary outcome [19] 0 0
Change From Baseline on the Dermatology Life Quality Index (DLQI)
Timepoint [19] 0 0
Baseline, Week 16
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, Week 16
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, Week 16
Secondary outcome [22] 0 0
Change From Baseline on the EQ-5D-5L Visual Analog Scale (VAS)
Timepoint [22] 0 0
Baseline, Week 16
Secondary outcome [23] 0 0
Mean Number of Days Without Use of Background TCS
Timepoint [23] 0 0
Week 0 through Week 16
Secondary outcome [24] 0 0
Percentage of Participants Achieving IGA of 0 or 1 With a = 2 Point Improvement
Timepoint [24] 0 0
Week 4

Eligibility
Key inclusion criteria
* Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months.
* Have had inadequate response 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 episodes 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 less than 4 weeks prior to randomization.
* Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection 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 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
16/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2019
Sample size
Target
Accrual to date
Final
329
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
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [5] 0 0
Clinical Trials SA Pty Ltd - Adelaide
Recruitment hospital [6] 0 0
Skin and Cancer Foundation Inc. - Melbourne
Recruitment hospital [7] 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
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5073 - Adelaide
Recruitment postcode(s) [6] 0 0
3053 - Melbourne
Recruitment postcode(s) [7] 0 0
6160 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad Autonoma Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Mendoza
Country [3] 0 0
Austria
State/province [3] 0 0
Steiermark
Country [4] 0 0
Germany
State/province [4] 0 0
Baden-Württemberg
Country [5] 0 0
Germany
State/province [5] 0 0
Bayern
Country [6] 0 0
Germany
State/province [6] 0 0
Hessen
Country [7] 0 0
Germany
State/province [7] 0 0
Niedersachsen
Country [8] 0 0
Germany
State/province [8] 0 0
Nordrhein-Westfalen
Country [9] 0 0
Germany
State/province [9] 0 0
Schleswig-Holstein
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Italy
State/province [12] 0 0
Lazio
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Italy
State/province [14] 0 0
Genova
Country [15] 0 0
Italy
State/province [15] 0 0
Pisa
Country [16] 0 0
Italy
State/province [16] 0 0
Vicenza
Country [17] 0 0
Japan
State/province [17] 0 0
Chiba
Country [18] 0 0
Japan
State/province [18] 0 0
Fukuoka
Country [19] 0 0
Japan
State/province [19] 0 0
Hokkaido
Country [20] 0 0
Japan
State/province [20] 0 0
Kanagawa
Country [21] 0 0
Japan
State/province [21] 0 0
Osaka
Country [22] 0 0
Japan
State/province [22] 0 0
Shizuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Japan
State/province [24] 0 0
Toyama
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Gyeonggi-do
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Korea
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Poland
State/province [28] 0 0
Lodz
Country [29] 0 0
Poland
State/province [29] 0 0
Swidnik
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Cordoba
Country [33] 0 0
Spain
State/province [33] 0 0
Las Palmas de Gran Canaria
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Taiwan
State/province [35] 0 0
Kaohsiung
Country [36] 0 0
Taiwan
State/province [36] 0 0
New Taipei City
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taichung City
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei City
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
Taiwan
State/province [40] 0 0
Taoyuan, (r.o.c.)

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/NCT03733301