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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03334435
Ethics application status
Date submitted
3/11/2017
Date registered
7/11/2017

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

Placebo comparator: Responders and Partial Responders (RPR)-Placebo - Responders or partial responders (RPR) \[Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.

Experimental: RPR-Bari 1-milligram (mg) - RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.

Experimental: RPR-Bari 2-mg - RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.

Experimental: RPR-Bari 4-mg - RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.

Experimental: Non-responders (NR): Bari 1 mg to 2 mg - Non-responder (NR) \[those not meeting definition of RPR\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

Experimental: NR: Bari 1 mg to 4 mg - NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

Experimental: NR: Bari 2 mg to 2 mg - NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

Experimental: NR: Bari 2 mg to 4 mg - NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

Experimental: NR: Bari 4 mg to 4 mg - NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

Experimental: NR: Placebo to Bari 2 mg - NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.

Experimental: NR: Placebo to Bari 4 mg - NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.

Placebo comparator: Placebo - Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Experimental: Bari 1 mg - Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Experimental: Bari 2 mg - Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

Experimental: Bari 4 mg - Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

Experimental: Bari 2-mg Open-Label Addendum - Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg 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
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
Timepoint [1] 0 0
Weeks 16, 36 and 52
Primary outcome [2] 0 0
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
Timepoint [2] 0 0
Weeks 16, 36, and 52
Secondary outcome [1] 0 0
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Timepoint [1] 0 0
Weeks 16, 36, and 52
Secondary outcome [2] 0 0
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
Timepoint [2] 0 0
Weeks 16, 36, and 52
Secondary outcome [3] 0 0
Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Timepoint [3] 0 0
Weeks 16, 36 and 52
Secondary outcome [4] 0 0
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
Timepoint [4] 0 0
Weeks 16, 36, and 52
Secondary outcome [5] 0 0
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
Timepoint [5] 0 0
Weeks 16, 36, 52
Secondary outcome [6] 0 0
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
Timepoint [6] 0 0
Weeks 16, 36, and 52
Secondary outcome [7] 0 0
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
Timepoint [7] 0 0
Weeks 16, 36, and 52 Weeks
Secondary outcome [8] 0 0
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
Timepoint [8] 0 0
Weeks 16, 36, and 52
Secondary outcome [9] 0 0
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
Timepoint [9] 0 0
Weeks 16, 36, and 52
Secondary outcome [10] 0 0
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
Timepoint [10] 0 0
Weeks 16, 36, and 52
Secondary outcome [11] 0 0
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS)
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
Timepoint [14] 0 0
Week 16
Secondary outcome [15] 0 0
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Timepoint [15] 0 0
Weeks 4, 16, 24, 52
Secondary outcome [16] 0 0
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
Timepoint [16] 0 0
Weeks 4, 16, 24, 52
Secondary outcome [17] 0 0
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
Timepoint [17] 0 0
Weeks 4, 16, 24, 52
Secondary outcome [18] 0 0
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
Timepoint [18] 0 0
Weeks 4, 16, 24, 52
Secondary outcome [19] 0 0
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
Timepoint [19] 0 0
Weeks 4, 16, 24, 52
Secondary outcome [20] 0 0
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
Timepoint [20] 0 0
Weeks 4, 16, 24, 52
Secondary outcome [21] 0 0
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
Timepoint [21] 0 0
Week 16
Secondary outcome [22] 0 0
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
Timepoint [22] 0 0
Week 16
Secondary outcome [23] 0 0
Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
Timepoint [23] 0 0
Weeks 68, 104
Secondary outcome [24] 0 0
Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
Timepoint [24] 0 0
Weeks 68, 104
Secondary outcome [25] 0 0
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
Timepoint [25] 0 0
Weeks 68, 104
Secondary outcome [26] 0 0
Time to Retreatment (Time to IGA =3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)
Timepoint [26] 0 0
Week 52 Up to Week 200
Secondary outcome [27] 0 0
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
Timepoint [27] 0 0
Weeks 68, 104
Secondary outcome [28] 0 0
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
Timepoint [28] 0 0
Weeks 68, 104
Secondary outcome [29] 0 0
Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)
Timepoint [29] 0 0
Weeks 68, 104
Secondary outcome [30] 0 0
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
Timepoint [30] 0 0
Week 68
Secondary outcome [31] 0 0
Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
Timepoint [31] 0 0
Week 68
Secondary outcome [32] 0 0
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
Timepoint [32] 0 0
Week 68
Secondary outcome [33] 0 0
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)
Timepoint [33] 0 0
Week 104
Secondary outcome [34] 0 0
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)
Timepoint [34] 0 0
Week 104
Secondary outcome [35] 0 0
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy)
Timepoint [35] 0 0
Week 104

Eligibility
Key inclusion criteria
Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions:



* 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

OR

Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:

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.



* 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
28/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/07/2023
Sample size
Target
Accrual to date
Final
1645
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
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
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
Country [11] 0 0
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
Country [44] 0 0
India
State/province [44] 0 0
Delhi
Country [45] 0 0
India
State/province [45] 0 0
Gujarat
Country [46] 0 0
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
Country [67] 0 0
Japan
State/province [67] 0 0
Ibaraki
Country [68] 0 0
Japan
State/province [68] 0 0
Kanagawa
Country [69] 0 0
Japan
State/province [69] 0 0
Kumamoto
Country [70] 0 0
Japan
State/province [70] 0 0
Kyoto
Country [71] 0 0
Japan
State/province [71] 0 0
Osaka
Country [72] 0 0
Japan
State/province [72] 0 0
Saitama
Country [73] 0 0
Japan
State/province [73] 0 0
Shimane
Country [74] 0 0
Japan
State/province [74] 0 0
Shizuoka
Country [75] 0 0
Japan
State/province [75] 0 0
Tochigi
Country [76] 0 0
Japan
State/province [76] 0 0
Tokyo
Country [77] 0 0
Japan
State/province [77] 0 0
Toyama
Country [78] 0 0
Japan
State/province [78] 0 0
Yamanashi
Country [79] 0 0
Japan
State/province [79] 0 0
Gifu
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Gyeonggi Do
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Gyeonggi-do
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Korea
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Seoul
Country [84] 0 0
Mexico
State/province [84] 0 0
Distrito Federal
Country [85] 0 0
Mexico
State/province [85] 0 0
Michoacan Morelia
Country [86] 0 0
Mexico
State/province [86] 0 0
Nuevo Leon
Country [87] 0 0
Mexico
State/province [87] 0 0
Nuevo León
Country [88] 0 0
Mexico
State/province [88] 0 0
Cuernavaca
Country [89] 0 0
Mexico
State/province [89] 0 0
Durango
Country [90] 0 0
Poland
State/province [90] 0 0
Kujawsko-pomorskie
Country [91] 0 0
Poland
State/province [91] 0 0
Lodzkie
Country [92] 0 0
Poland
State/province [92] 0 0
Lubelskie
Country [93] 0 0
Poland
State/province [93] 0 0
Malopolskie
Country [94] 0 0
Poland
State/province [94] 0 0
Mazowieckie
Country [95] 0 0
Poland
State/province [95] 0 0
Podlaskie
Country [96] 0 0
Poland
State/province [96] 0 0
Pomorskie
Country [97] 0 0
Poland
State/province [97] 0 0
Slaskie
Country [98] 0 0
Poland
State/province [98] 0 0
Warminsko-mazurskie
Country [99] 0 0
Poland
State/province [99] 0 0
Zachodniopomorskie
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Krasnodarskiy Kray
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Moscow
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Saint-Petersburg
Country [103] 0 0
Russian Federation
State/province [103] 0 0
St. Petersburg
Country [104] 0 0
Spain
State/province [104] 0 0
Badalona
Country [105] 0 0
Spain
State/province [105] 0 0
Madrid
Country [106] 0 0
Spain
State/province [106] 0 0
Navarra
Country [107] 0 0
Spain
State/province [107] 0 0
Alicante
Country [108] 0 0
Spain
State/province [108] 0 0
Barcelona
Country [109] 0 0
Spain
State/province [109] 0 0
Las Palmas de Gran Canaria
Country [110] 0 0
Spain
State/province [110] 0 0
Pontevedra
Country [111] 0 0
Switzerland
State/province [111] 0 0
Vaud
Country [112] 0 0
Switzerland
State/province [112] 0 0
Bern
Country [113] 0 0
Switzerland
State/province [113] 0 0
Genève
Country [114] 0 0
Switzerland
State/province [114] 0 0
Zürich
Country [115] 0 0
Taiwan
State/province [115] 0 0
Kaohsiung
Country [116] 0 0
Taiwan
State/province [116] 0 0
New Taipei City
Country [117] 0 0
Taiwan
State/province [117] 0 0
Taichung City
Country [118] 0 0
Taiwan
State/province [118] 0 0
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
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?
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT03334435