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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03334435




Registration number
NCT03334435
Ethics application status
Date submitted
3/11/2017
Date registered
7/11/2017
Date last updated
17/03/2020

Titles & IDs
Public title
A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
Scientific title
A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
Secondary ID [1] 0 0
I4V-MC-JAHN
Secondary ID [2] 0 0
16587
Universal Trial Number (UTN)
Trial acronym
BREEZE-AD3
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: Baricitinib High Dose Nonresponders - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Experimental: Baricitinib High Dose Nonresponders Rescued - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Experimental: Baricitinib Mid Dose Nonresponders Rescued - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Experimental: Baricitinib High Dose Responders - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Experimental: Baricitinib Mid Dose Responders - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Experimental: Baricitinib Low Dose Responders - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Placebo Comparator: Placebo Responders - Placebo administered orally.

Experimental: Baricitinib Open Label Extension - Baricitinib administered orally.


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
Proportion of Participants with a Response of Investigator's Global Assessment (IGA) 0 or 1 at 16 Weeks - Proportion of participants achieving IGA 0 or 1 at 16 weeks
Timepoint [1] 0 0
16 Weeks
Primary outcome [2] 0 0
Proportion of Participants with a Response of IGA 0 or 1 at 36 Weeks - Proportion of participants achieving IGA 0 or 1 at 36 weeks
Timepoint [2] 0 0
36 Weeks
Primary outcome [3] 0 0
Proportion of Participants with a Response of IGA 0 or 1 at 52 Weeks - Proportion of participants achieving IGA 0 or 1 at 52 weeks
Timepoint [3] 0 0
52 Weeks
Secondary outcome [1] 0 0
Proportion of Participants Achieving IGA 0, 1 or 2 - Proportion of participants achieving IGA 0,1 or 2
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Proportion of Participants Achieving IGA 0 or 1 (non-responders) - Proportion of participants achieving IGA 0 or 1
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Proportion of Participants Achieving Response of Eczema Area and Severity Index (EASI)75 from Baseline of Originating Study - Proportion of participants achieving response of EASI75 from baseline of originating study
Timepoint [3] 0 0
52 Weeks
Secondary outcome [4] 0 0
Proportion of Participants with a 4-Point Improvement from Baseline of Originating Study in Itch NRS - Proportion of participants with a 4 point improvement from baseline of originating study in Itch NRS
Timepoint [4] 0 0
16 Weeks

Eligibility
Key inclusion criteria
- Have completed the final active treatment visit for an originating study eligible to
enroll participants directly into study BREEZE-AD3 OR

- Meet criteria for NCT03334396 or NCT03334422.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Had investigational product permanently discontinued at any time during a previous
baricitinib study.

- Had temporary investigational product interruption continue at the final study visit
of a previous baricitinib study and, in the opinion of the investigator, this poses an
unacceptable risk for the participant's participation in the 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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. - Carlton
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 - Carlton
Recruitment postcode(s) [7] 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
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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
Steiermark
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Czechia
State/province [7] 0 0
Hl. M. Praha
Country [8] 0 0
Czechia
State/province [8] 0 0
Jihomoravský Kraj
Country [9] 0 0
Czechia
State/province [9] 0 0
Moravskoslezsky Kraj
Country [10] 0 0
Czechia
State/province [10] 0 0
Plzenský Kraj
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Czechia
State/province [11] 0 0
Stredoceský Kraj
Country [12] 0 0
Czechia
State/province [12] 0 0
Ustecký Kraj
Country [13] 0 0
Denmark
State/province [13] 0 0
Region Hovedstaden
Country [14] 0 0
Denmark
State/province [14] 0 0
Region Midtjyland
Country [15] 0 0
France
State/province [15] 0 0
Cedex 10
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux Cedex
Country [17] 0 0
France
State/province [17] 0 0
Grenoble Cédex 9
Country [18] 0 0
France
State/province [18] 0 0
Nantes Cedex 1
Country [19] 0 0
France
State/province [19] 0 0
Nice cedex 3
Country [20] 0 0
France
State/province [20] 0 0
Pierre Benite Cedex
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
Germany
State/province [22] 0 0
Baden-Württemberg
Country [23] 0 0
Germany
State/province [23] 0 0
Bayern
Country [24] 0 0
Germany
State/province [24] 0 0
Brandenburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hessen
Country [26] 0 0
Germany
State/province [26] 0 0
Mecklenburg-Vorpommern
Country [27] 0 0
Germany
State/province [27] 0 0
Niedersachsen
Country [28] 0 0
Germany
State/province [28] 0 0
Nordrhein-Westfalen
Country [29] 0 0
Germany
State/province [29] 0 0
Sachsen-Anhalt
Country [30] 0 0
Germany
State/province [30] 0 0
Sachsen
Country [31] 0 0
Germany
State/province [31] 0 0
Schleswig-Holstein
Country [32] 0 0
Germany
State/province [32] 0 0
Aachen
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Hungary
State/province [35] 0 0
Bekes
Country [36] 0 0
Hungary
State/province [36] 0 0
Csongrad
Country [37] 0 0
Hungary
State/province [37] 0 0
Hajdu-Bihar
Country [38] 0 0
Hungary
State/province [38] 0 0
Jasz-Nagykun-Szolnok
Country [39] 0 0
Hungary
State/province [39] 0 0
Somogy
Country [40] 0 0
Hungary
State/province [40] 0 0
Vas
Country [41] 0 0
Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Hungary
State/province [42] 0 0
Veszprem
Country [43] 0 0
India
State/province [43] 0 0
Andhra Pradesh
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India
State/province [44] 0 0
Delhi
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India
State/province [45] 0 0
Gujarat
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India
State/province [46] 0 0
Maharashtra
Country [47] 0 0
India
State/province [47] 0 0
Maharshtra
Country [48] 0 0
India
State/province [48] 0 0
Telangana
Country [49] 0 0
Israel
State/province [49] 0 0
Afula
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Petach Tikva
Country [53] 0 0
Israel
State/province [53] 0 0
Ramat Gan
Country [54] 0 0
Israel
State/province [54] 0 0
Tel Aviv
Country [55] 0 0
Italy
State/province [55] 0 0
Lazio
Country [56] 0 0
Italy
State/province [56] 0 0
Milano
Country [57] 0 0
Italy
State/province [57] 0 0
Genova
Country [58] 0 0
Italy
State/province [58] 0 0
Napoli
Country [59] 0 0
Italy
State/province [59] 0 0
Pisa
Country [60] 0 0
Italy
State/province [60] 0 0
Roma
Country [61] 0 0
Italy
State/province [61] 0 0
Verona
Country [62] 0 0
Italy
State/province [62] 0 0
Vicenza
Country [63] 0 0
Japan
State/province [63] 0 0
Chiba
Country [64] 0 0
Japan
State/province [64] 0 0
Fukuoka
Country [65] 0 0
Japan
State/province [65] 0 0
Hiroshima-ken
Country [66] 0 0
Japan
State/province [66] 0 0
Hokkaido
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Japan
State/province [67] 0 0
Ibaraki
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Japan
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Kanagawa
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Japan
State/province [69] 0 0
Kumamoto
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Japan
State/province [70] 0 0
Kyoto
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Japan
State/province [71] 0 0
Osaka
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Japan
State/province [72] 0 0
Saitama
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Japan
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Shimane
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Japan
State/province [74] 0 0
Shizuoka
Country [75] 0 0
Japan
State/province [75] 0 0
Tochigi
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Yamanashi
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Japan
State/province [79] 0 0
Gifu
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Korea, Republic of
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Gyeonggi Do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Korea
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Korea, Republic of
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Seoul
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Distrito Federal
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Mexico
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Mexico
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Nuevo Leon
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Mexico
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Nuevo León
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Mexico
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Cuernavaca
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Mexico
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Durango
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Kujawsko-pomorskie
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Lodzkie
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Lubelskie
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Malopolskie
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Mazowieckie
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Podlaskie
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Pomorskie
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Slaskie
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Warminsko-mazurskie
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Poland
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Zachodniopomorskie
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Russian Federation
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Krasnodarskiy Kray
Country [101] 0 0
Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Spain
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Badalona
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Madrid
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Spain
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Navarra
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Alicante
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Spain
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Barcelona
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Spain
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Las Palmas de Gran Canaria
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Spain
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Pontevedra
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Switzerland
State/province [111] 0 0
Vaud
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Switzerland
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Bern
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Switzerland
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Genève
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Switzerland
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Zürich
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
Country [117] 0 0
Taiwan
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Taichung City
Country [118] 0 0
Taiwan
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Tainan
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taipei City
Country [120] 0 0
Taiwan
State/province [120] 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 long-term safety and efficacy of baricitinib in
participants with atopic dermatitis.
Trial website
https://clinicaltrials.gov/show/NCT03334435
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