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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03952559




Registration number
NCT03952559
Ethics application status
Date submitted
15/05/2019
Date registered
16/05/2019
Date last updated
16/10/2024

Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
I4V-MC-JAIP
Secondary ID [2] 0 0
16966
Universal Trial Number (UTN)
Trial acronym
BREEZE-AD-PEDS
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
Treatment: Drugs - Topical corticosteroid

Experimental: Baricitinib Open Label High Dose (PK Lead-in) - Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.

Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.

Experimental: Baricitinib High Dose - Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Experimental: Baricitinib Medium Dose - Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Experimental: Baricitinib Low Dose - Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Placebo comparator: Placebo - Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.


Treatment: Drugs: Baricitinib
Administered orally

Treatment: Drugs: Placebo
Administered orally

Treatment: Drugs: Topical corticosteroid
Administered as standard-of-care
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
Primary outcome [2] 0 0
Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
Timepoint [2] 0 0
Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Primary outcome [3] 0 0
Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Timepoint [3] 0 0
Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
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
Change From Baseline in 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) for Participants 10 to <18 Years Old at Study Entry
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants Achieving EASI50
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Percentage of Participants Achieving IGA of 0
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Change From Baseline in SCORAD
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Percentage of Participants Achieving SCORAD90
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change From Baseline in Body Surface Area (BSA) Affected
Timepoint [10] 0 0
Baseline, Week 16
Secondary outcome [11] 0 0
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)
Timepoint [12] 0 0
Baseline Through 16 Weeks
Secondary outcome [13] 0 0
Mean Gram Quantity of TCS Use (Tube Weights)
Timepoint [13] 0 0
Baseline through 16 Weeks
Secondary outcome [14] 0 0
Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry
Timepoint [14] 0 0
Baseline, Week 16
Secondary outcome [15] 0 0
Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry
Timepoint [15] 0 0
Baseline, Week 16
Secondary outcome [16] 0 0
Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score
Timepoint [16] 0 0
Baseline, Week 16
Secondary outcome [17] 0 0
Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry
Timepoint [17] 0 0
Baseline, Week 16
Secondary outcome [18] 0 0
Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry
Timepoint [18] 0 0
Baseline, Week 16
Secondary outcome [19] 0 0
Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry
Timepoint [19] 0 0
Baseline, Week 16
Secondary outcome [20] 0 0
Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry
Timepoint [20] 0 0
Baseline, Week 16
Secondary outcome [21] 0 0
Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry
Timepoint [21] 0 0
Week 16
Secondary outcome [22] 0 0
Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score
Timepoint [22] 0 0
Baseline, Week 16
Secondary outcome [23] 0 0
Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry
Timepoint [23] 0 0
Baseline, Week 16
Secondary outcome [24] 0 0
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants 10 to <18 Years at Study Entry
Timepoint [24] 0 0
Baseline, Week 16
Secondary outcome [25] 0 0
Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry
Timepoint [25] 0 0
Baseline, Week 16
Secondary outcome [26] 0 0
Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry
Timepoint [26] 0 0
Week 2
Secondary outcome [27] 0 0
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry
Timepoint [27] 0 0
Week 2
Secondary outcome [28] 0 0
Height, Weight and Body Mass Index (BMI) Growth Rate
Timepoint [28] 0 0
124 Weeks
Secondary outcome [29] 0 0
Change of Immunoglobulin G (IgG) Titers
Timepoint [29] 0 0
Baseline Through End of Study Completion
Secondary outcome [30] 0 0
Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
Timepoint [30] 0 0
Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Secondary outcome [31] 0 0
Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Timepoint [31] 0 0
Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Eligibility
Key inclusion criteria
* At or above the 5th percentile of weight for age.
* Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).
* 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
2 Years
Maximum age
17 Years
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 beginning study treatment.
* 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 initiation of study drug 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 initiation of study drug.
* Have high blood pressure characterized by a repeated systolic or diastolic blood pressure >95th percentile based on age, sex and height.
* 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 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 (shingles or chicken pox), 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/05/2026
Actual
Sample size
Target
Accrual to date
Final
516
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [3] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3052 - Melbourne
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
Austria
State/province [3] 0 0
Steiermark
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Brazil
State/province [5] 0 0
Rio Grande Do Sul
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio de Janeiro
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Czechia
State/province [9] 0 0
Hradec Králové
Country [10] 0 0
Czechia
State/province [10] 0 0
Nový Jicín
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 5
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha 8
Country [13] 0 0
Czechia
State/province [13] 0 0
Praha 2
Country [14] 0 0
France
State/province [14] 0 0
Alpes-Maritimes
Country [15] 0 0
France
State/province [15] 0 0
Drôme
Country [16] 0 0
France
State/province [16] 0 0
Finistère
Country [17] 0 0
France
State/province [17] 0 0
Languedoc-Roussillon
Country [18] 0 0
France
State/province [18] 0 0
Loire-Atlantique
Country [19] 0 0
France
State/province [19] 0 0
Midi-Pyrénées
Country [20] 0 0
France
State/province [20] 0 0
Nord-Pas-de-Calais
Country [21] 0 0
Germany
State/province [21] 0 0
Hessen
Country [22] 0 0
Germany
State/province [22] 0 0
Nordrhein-Westfalen
Country [23] 0 0
Germany
State/province [23] 0 0
Sachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Hungary
State/province [25] 0 0
Csongrad
Country [26] 0 0
Hungary
State/province [26] 0 0
Jasz-Nagykun-Szolnok
Country [27] 0 0
India
State/province [27] 0 0
Delhi
Country [28] 0 0
India
State/province [28] 0 0
Gujarat
Country [29] 0 0
Israel
State/province [29] 0 0
HaDarom
Country [30] 0 0
Israel
State/province [30] 0 0
HaMerkaz
Country [31] 0 0
Israel
State/province [31] 0 0
HaTsafon
Country [32] 0 0
Israel
State/province [32] 0 0
Tell Abib
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi
Country [34] 0 0
Japan
State/province [34] 0 0
Hiroshima
Country [35] 0 0
Japan
State/province [35] 0 0
Hokkaido
Country [36] 0 0
Japan
State/province [36] 0 0
Kanagawa
Country [37] 0 0
Japan
State/province [37] 0 0
Mie
Country [38] 0 0
Japan
State/province [38] 0 0
Osaka
Country [39] 0 0
Japan
State/province [39] 0 0
Tochigi
Country [40] 0 0
Japan
State/province [40] 0 0
Fukuoka
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Mexico
State/province [42] 0 0
Jalisco
Country [43] 0 0
Mexico
State/province [43] 0 0
Nuevo León
Country [44] 0 0
Mexico
State/province [44] 0 0
Durango
Country [45] 0 0
Mexico
State/province [45] 0 0
Veracruz
Country [46] 0 0
Poland
State/province [46] 0 0
Lodzkie
Country [47] 0 0
Poland
State/province [47] 0 0
Malopolskie
Country [48] 0 0
Poland
State/province [48] 0 0
Pomorskie
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Krasnodarskiy Kray
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Moskva
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Tul'skaya Oblast'
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona [Barcelona]
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid, Comunidad De
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Navarra
Country [56] 0 0
Spain
State/province [56] 0 0
Pontevedra [Pontevedra]
Country [57] 0 0
Taiwan
State/province [57] 0 0
Kaohsiung
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taichung City
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taipei
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taoyuan
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Glasgow City
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London, City Of
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Nottinghamshire

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 reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
Trial website
https://clinicaltrials.gov/study/NCT03952559
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03952559