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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03733301
Ethics application status
Date submitted
30/10/2018
Date registered
7/11/2018
Date last updated
23/09/2019

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: Baricitinib High Dose - Baricitinib administered orally in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

Experimental: Baricitinib Low Dose - Baricitinib administered orally in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

Placebo Comparator: Placebo - Placebo administered orally in combination with topical corticosteroids.


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
Proportion of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a = 2 Point Improvement - Proportion of participants achieving IGA of 0 or 1 with a = 2 point improvement
Timepoint [1] 0 0
16 Weeks
Secondary outcome [1] 0 0
Proportion of Participants Achieving Eczema Area and Severity Index 75 (EASI75) - Proportion of participants achieving EASI75
Timepoint [1] 0 0
16 Weeks
Secondary outcome [2] 0 0
Proportion of Participants Achieving EASI90 - Proportion of participants achieving EASI90
Timepoint [2] 0 0
16 Weeks
Secondary outcome [3] 0 0
Percent Change from Baseline on EASI Score - Percent change from baseline on EASI Score
Timepoint [3] 0 0
Baseline, 16 Weeks
Secondary outcome [4] 0 0
Proportion of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) - Proportion of participants achieving SCORAD75
Timepoint [4] 0 0
16 Weeks
Secondary outcome [5] 0 0
Proportion of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS) - Proportion of participants achieving a 4-Point improvement on the Itch NRS
Timepoint [5] 0 0
16 Weeks
Secondary outcome [6] 0 0
Change from Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) - Change from baseline in the score of item 2 of the ADSS
Timepoint [6] 0 0
Baseline, 16 Weeks
Secondary outcome [7] 0 0
Change from Baseline in Skin Pain NRS - Change from baseline in skin pain NRS
Timepoint [7] 0 0
Baseline, 16 Weeks
Secondary outcome [8] 0 0
Proportion of Participants Achieving EASI50 - Proportion of participants achieving EASI50
Timepoint [8] 0 0
16 Weeks
Secondary outcome [9] 0 0
Proportion of Participants Achieving IGA of 0 - Proportion of participants achieving IGA of 0
Timepoint [9] 0 0
16 Weeks
Secondary outcome [10] 0 0
Change from Baseline in SCORAD - Change from baseline in SCORAD
Timepoint [10] 0 0
Baseline, 16 Weeks
Secondary outcome [11] 0 0
Proportion of Participants Achieving SCORAD90 - Proportion of participants achieving SCORAD90
Timepoint [11] 0 0
16 Weeks
Secondary outcome [12] 0 0
Change from Baseline in Body Surface Area (BSA) Affected - Change from baseline in BSA affected
Timepoint [12] 0 0
Baseline, 16 Weeks
Secondary outcome [13] 0 0
Proportion of Participants Developing Skin Infections Requiring Antibiotic Treatment - Proportion of participants developing skin infections requiring antibiotic treatment
Timepoint [13] 0 0
16 Weeks
Secondary outcome [14] 0 0
Mean Gram Quantity of TCS Use (Tube Weights) - Mean gram quantity of TCS use (tube weights)
Timepoint [14] 0 0
16 Weeks
Secondary outcome [15] 0 0
Percent Change from Baseline in Itch NRS - 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) - Change from baseline in the total score of the 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 - Change from baseline in the PGI-S-AD score
Timepoint [17] 0 0
Baseline, 16 Weeks
Secondary outcome [18] 0 0
Change from Baseline on the Hospital Anxiety Depression Scale (HADS) - Change from baseline on the HADS
Timepoint [18] 0 0
Baseline, 16 Weeks
Secondary outcome [19] 0 0
Change from Baseline on the Dermatology Life Quality Index (DLQI) - Change from baseline on the 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 - Change from baseline on the 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) - Change from Baseline on the EQ-5D-5L
Timepoint [21] 0 0
Baseline, 16 Weeks
Secondary outcome [22] 0 0
Mean Number of Days without Use of Background TCS - Mean number of days without use of background TCS
Timepoint [22] 0 0
Baseline through 16 Weeks

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
Gender
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
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)
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
The purpose of this study is to evaluate the efficacy and safety of baricitinib in
combination with topical corticosteroids (TCS) in participants with moderate to severe atopic
dermatitis.
Trial website
https://clinicaltrials.gov/show/NCT03733301
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

Summary results
Other publications