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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
Date last updated
22/01/2020

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
The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.
Trial website
https://clinicaltrials.gov/study/NCT03334422
Trial related presentations / publications
Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
Silverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8.
Thyssen JP, Buhl T, Fernandez-Penas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Stander S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18.
Buhl T, Rosmarin D, Serra-Baldrich E, Fernandez-Penas P, Igarashi A, Konstantinou MP, Chen S, Lu N, Pierce E, Casillas M. Itch and Sleep Improvements with Baricitinib in Patients with Atopic Dermatitis: A Post Hoc Analysis of 3 Phase 3 Studies. Dermatol Ther (Heidelb). 2021 Jun;11(3):971-982. doi: 10.1007/s13555-021-00534-8. Epub 2021 Apr 25.
King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
Reich K, DeLozier AM, Nunes FP, Thyssen JP, Eichenfield LF, Wollenberg A, Ross Terres JA, Watts SD, Chen YF, Simpson EL, Silverberg JI. Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials. J Dermatolog Treat. 2022 May;33(3):1521-1530. doi: 10.1080/09546634.2020.1839008. Epub 2020 Nov 22.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03334422