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A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis (BREEZE-AD-PEDS)

Primary Purpose

Atopic Dermatitis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Baricitinib

Placebo

Topical corticosteroid

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, atopic eczema

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Centro de Investigaciones Metabólicas (CINME)
Instituto de Neumonología Y Dermatología
Centro Medico Dra. De Salvo
Fundacion CIDEA
The Sydney Children's Hospitals Network
Veracity Clinical Research
Royal Children's Hospital
Universitätsklinikum Graz
Medizinische Universität Wien
Sozialmedizinisches Zentrum Ost/Donauspital
Hospital de Clinicas de Porto Alegre
Fundação Faculdade de Medicina do ABC
Instituto Brasil de Pesquisa Clínica - IBPCLIN
IDERJ - Instituto de Dermatologia e Estética do Brasil
Hospital de Servidor Publico Estadual
Fakultni Nemocnice v Motole
Fakultni nemocnice Bulovka
Nemocnice AGEL Novy Jicin a.s.
Fakultni nemocnice Hradec Kralove
Sanatorium profesora Arenbergera
Hopital Saint Eloi
CHRU de Brest - Hôpital Morvan
Hôpital Saint Vincent de Paul
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
CHU de Nice Hopital de L'Archet
Hopitaux Drome-Nord
Hopital Larrey
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Universitätsklinikum Münster
Universitätsklinikum Carl Gustav Carus
Katholisches Kinderkrankenhaus Wilhelmstift
SZTE AOK Borgyogyaszati es Allergologiai Klinika
Allergo-Derm Bakos Kft
All India Institute of Medical Sciences
Sir Ganga Ram Hospital
B. J. Medical College & Civil Hospital
Thalassemia and Sickle Cell Centre Rughwani Child Care Center and Hospital
Dr. D. Y. Patil Medical College & Hospital
Acharya Vinoba Bhave Rural Hospital
Lady Harding Medical College & Hospital
Lifepoint Multispecialty Hsptl
Postgraduate Institute of Medical Education & Research
Aakash Healthcare Super Speciality Hospital
Sheba Medical Center
Ha'Emek Medical Center
Soroka Medical Center
Tel Aviv Sourasky Medical Center
Nagoya Medical Center
Fukuyama City Hospital
Takeda Dermatology Skincare Clinic
National Sagamihara Hospital
Japan National Hospital Organization Mie Hospital
Dermatology and Ophthalmology Kume Clinic
Senri-Chuo Hanafusa Dermatology Clinic
Dokkyo Medical University Hospital
Matsuda Tomoko Dermatological Clinic
Shinjuku Minamiguchi Hifuka
Consultorio Privado de la Dra. Villanueva
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
CRI Centro Regiomontano de Investigación
Arke Estudios Clinicos S.A. de C.V.
Dermed Centrum Medyczne Sp. z o.o.
Diamond Clinic
Centrum Badan Klinicznych PI-House sp. z o.o.
GBUZ Clinical dermatology and venereological dispensary
Scientific Center of Children's Health
Tula Regional Clinical Dermatovenerological Dispensary
Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology
Hospital Sant Joan de Déu
Hospital Infantil Universitario Niño Jesús
Hospital Univ. Puerta de Hierro
Hospital Universitario Quironsalud Madrid
Clinica Universitaria De Navarra
Clinica Universidad Navarra-Sede Madrid
Hospital Universitario La Paz
Centro de Especialidades Mollabao
Chang Gung Memorial Hospital - Kaohsiung Branch
Chung Shan Medical University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital
Chang Gung Memorial Hospital - Taipei
Chang Gung Memorial Hospital - Linkou
St Thomas's Hospital
Queen's Medical Centre, Nottingham University Hospitals
Royal Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Baricitinib Open Label High Dose (PK Lead-in)

Baricitinib High Dose

Baricitinib Medium Dose

Baricitinib Low Dose

Placebo

Arm Description

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.

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.

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.

Participants 10 to < 18 years received placebo tablets. Participants 2 to < 10 years received placebo as oral suspension.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement

Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

Secondary Outcome Measures

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.

Percentage of Participants Achieving EASI90

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.

Change From Baseline in EASI Score

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.

Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry

The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.

Percentage of Participants Achieving EASI50

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.

Percentage of Participants Achieving IGA of 0

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Change From Baseline in SCORAD

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Percentage of Participants Achieving SCORAD90

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.

Change From Baseline in Body Surface Area (BSA) Affected

Body surface area affected by atopic dermatitis will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of atopic dermatitis. LS Means calculated using MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

Percentage of participants developing skin infections requiring antibiotic treatment

Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)

Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.

Mean Gram Quantity of TCS Use (Tube Weights)

The dispensed TCS tubes were weighed with cap (without the carton) to determine the dispensed amount of TCS in grams. Returned tubes were weighed with cap (without the carton) to determine the amount of TCS in grams used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.

Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry

The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry

The Parent-Reported Itch Severity Measure (PRISM) is a single-item, parent/caregiver administered scale that reports the overall severity of their child's itching. Parent/Caregiver's report the overall severity of their child's itching based on observed actions of the child in the past 24 hours. Response options range include "No Itch," "Mild," "Moderate," "Severe," and "Very Severe." The PRISM will be completed for participants <10 years old by the parent/caregiver. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score

The POEM is a simple, 7-item, patient-administered scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). Scores range from 0-28 with higher total scores indicating greater disease severity. LS Means were calculated using MMRM model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry

The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall atopic dermatitis symptoms over the past 24 hours to evaluate the severity of the disease at that point in time. The 5 categories of responses range from "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe". LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental and social health in adults and children. The PROMIS Depression item bank assesses self-reported negative mood (sadness, guilt), views on self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive affect and engagement (loss of interest, meaning, and purpose). The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for children (ages 5 to <8 years). Children aged <5 years will not complete assessment. Both pediatric self-report and proxy-report versions assess depression "in past seven days." Response options range from 1 = Never;2 = Rarely;3 = Sometimes;4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean= 50 and a standard deviation = 10) with higher scores representing greater depression.

Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Anxiety item bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to <8 years old). Children aged <5 years will not complete this assessment. Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days." Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.

Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry

CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score

The Atopic Dermatitis Caregiver (WPAI-AD-CG) assesses the effect of a child's atopic dermatitis on the parent/caregiver's work productivity during the past 7 days. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, Scores are calculated as impairment percentages with higher scores indicating greater impairment and less productivity. LS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry

The EQ-5D-Y questionnaire is health status related and self-completed for pediatric participants ≥8 years old and completed by parents/caregivers for children 4 to <8 years old. Health state profile assessed health in 5 dimensions (Mobility,selfcare,usual activities,pain/discomfort, anxiety/depression) to obtain index score, each with three levels of response (no problems,some problems,a lot of problems). Participants indicated their health state by choosing appropriate level from each dimension. Visual analog scale on which participant rates their perceived health state from 0 ("worst health you can imagine") to 100 ("best health you can imagine") is presented.Higher the score the better the health status. LS Means uses MMRM model which includes treatment,age cohort,region,baseline disease severity(IGA),visit,treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

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

Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.

Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry

Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry

The questionnaire for Suspension acceptability and palatability assessed the participants ability to swallow the oral suspension product, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".

Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry

The questionnaire for tablet acceptability and palatability assessed the participants ability to swallow the tablet. The questionnaire contained the question 1) How easy was it for you (your child) to swallow the medicine today? Responses: Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".

Height, Weight and Body Mass Index (BMI) Growth Rate

Height, Weight and BMI Growth Rate will be reported.

Change of Immunoglobulin G (IgG) Titers

Number of participants with change of IgG titers for tetanus vaccine and pneumococcal conjugate will be presented. A primary immune response was assessed in participants who had never received tetanus or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with >= 2-fold increase in >=6 pneumococcal serotypes from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented. For tetanus vaccine, number of participants with >= 2-fold increase in participants with baseline titer >=0.1 IU/mL from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented.

Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

Full Information

NCT ID

NCT03952559

First Posted

May 15, 2019

Last Updated

June 9, 2023

Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03952559

Brief Title

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

Acronym

BREEZE-AD-PEDS

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 24, 2019 (Actual)

Primary Completion Date

April 24, 2022 (Actual)

Study Completion Date

May 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

eczema, atopic eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Participants were randomized to one of the four double-blind treatment arms. A separate group of 33 participants received open label baricitinib as part of pharmacokinetic (PK) lead-in (not randomized) period.

Allocation

Randomized

Enrollment

516 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baricitinib Open Label High Dose (PK Lead-in)

Arm Type

Experimental

Arm Description

Arm Title

Baricitinib High Dose

Arm Type

Experimental

Arm Description

Arm Title

Baricitinib Medium Dose

Arm Type

Experimental

Arm Description

Arm Title

Baricitinib Low Dose

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants 10 to < 18 years received placebo tablets. Participants 2 to < 10 years received placebo as oral suspension.

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Other Intervention Name(s)

LY3009104

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Topical corticosteroid

Intervention Description

Administered as standard-of-care

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement

Description

Time Frame

Week 16

Title

Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Description

Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

Time Frame

Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Title

Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

Description

Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

Time Frame

Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving EASI90

Description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.

Time Frame

Week 16

Title

Change From Baseline in EASI Score

Description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Time Frame

Baseline, Week 16

Title

Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving EASI50

Description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.

Time Frame

Week 16

Title

Percentage of Participants Achieving IGA of 0

Description

Time Frame

Week 16

Title

Change From Baseline in SCORAD

Description

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Time Frame

Baseline, Week 16

Title

Percentage of Participants Achieving SCORAD90

Description

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.

Time Frame

Week 16

Title

Change From Baseline in Body Surface Area (BSA) Affected

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

Description

Percentage of participants developing skin infections requiring antibiotic treatment

Time Frame

Week 16

Title

Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)

Description

Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.

Time Frame

Baseline Through 16 Weeks

Title

Mean Gram Quantity of TCS Use (Tube Weights)

Description

Time Frame

Baseline through 16 Weeks

Title

Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry

Description

Time Frame

Week 16

Title

Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry

Description

Time Frame

Baseline, Week 16

Title

Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry

Description

Time Frame

Week 2

Title

Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry

Description

Time Frame

Week 2

Title

Height, Weight and Body Mass Index (BMI) Growth Rate

Description

Height, Weight and BMI Growth Rate will be reported.

Time Frame

124 Weeks

Title

Change of Immunoglobulin G (IgG) Titers

Description

Time Frame

Baseline Through End of Study Completion

Title

Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Description

Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

Time Frame

Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Title

Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

Description

Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

Time Frame

Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Centro de Investigaciones Metabólicas (CINME)

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1027AAP

Country

Argentina

Facility Name

Instituto de Neumonología Y Dermatología

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEA

Country

Argentina

Facility Name

Centro Medico Dra. De Salvo

City

Capital Federal

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Fundacion CIDEA

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1121ABE

Country

Argentina

Facility Name

The Sydney Children's Hospitals Network

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Veracity Clinical Research

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Royal Children's Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Universitätsklinikum Graz

City

Graz

State/Province

Steiermark

ZIP/Postal Code

8036

Country

Austria

Facility Name

Medizinische Universität Wien

City

Wien

State/Province

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Sozialmedizinisches Zentrum Ost/Donauspital

City

Vienna

State/Province

Wien

ZIP/Postal Code

1220

Country

Austria

Facility Name

Hospital de Clinicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Fundação Faculdade de Medicina do ABC

City

Santo André

State/Province

Sao Paulo

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

Instituto Brasil de Pesquisa Clínica - IBPCLIN

City

Rio de Janeiro

ZIP/Postal Code

20241180

Country

Brazil

Facility Name

IDERJ - Instituto de Dermatologia e Estética do Brasil

City

Rio de Janeiro

ZIP/Postal Code

22470-220

Country

Brazil

Facility Name

Hospital de Servidor Publico Estadual

City

São Paulo

ZIP/Postal Code

04039-901

Country

Brazil

Facility Name

Fakultni Nemocnice v Motole

City

Praha 5

State/Province

Hl. M. Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Fakultni nemocnice Bulovka

City

Praha 8

State/Province

Hl. M. Praha

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Nemocnice AGEL Novy Jicin a.s.

City

Novy Jicin

State/Province

Moravskoslezsky Kraj

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

Fakultni nemocnice Hradec Kralove

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Sanatorium profesora Arenbergera

City

Praha 2

ZIP/Postal Code

128 00

Country

Czechia

Facility Name

Hopital Saint Eloi

City

Montpellier Cédex 05

State/Province

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

CHRU de Brest - Hôpital Morvan

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Hôpital Saint Vincent de Paul

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

CHU de Nice Hopital de L'Archet

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Hopitaux Drome-Nord

City

Romans-sur-Isere

ZIP/Postal Code

26102

Country

France

Facility Name

Hopital Larrey

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

Facility Name

Universitätsklinikum Münster

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

Universitätsklinikum Carl Gustav Carus

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Katholisches Kinderkrankenhaus Wilhelmstift

City

Hamburg

ZIP/Postal Code

22149

Country

Germany

Facility Name

SZTE AOK Borgyogyaszati es Allergologiai Klinika

City

Szeged

State/Province

Csongrad

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Allergo-Derm Bakos Kft

City

Szolnok

State/Province

Jasz-Nagykun-Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

All India Institute of Medical Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Sir Ganga Ram Hospital

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

B. J. Medical College & Civil Hospital

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380016

Country

India

Facility Name

Thalassemia and Sickle Cell Centre Rughwani Child Care Center and Hospital

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

44001

Country

India

Facility Name

Dr. D. Y. Patil Medical College & Hospital

City

Navi Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400706

Country

India

Facility Name

Acharya Vinoba Bhave Rural Hospital

City

Wardha

State/Province

Maharashtra

ZIP/Postal Code

442004

Country

India

Facility Name

Lady Harding Medical College & Hospital

City

Delhi

State/Province

New Delhi

ZIP/Postal Code

110001

Country

India

Facility Name

Lifepoint Multispecialty Hsptl

City

Wakad

State/Province

Pune

ZIP/Postal Code

411057

Country

India

Facility Name

Postgraduate Institute of Medical Education & Research

City

Chandigarh

State/Province

Punjab

ZIP/Postal Code

160012

Country

India

Facility Name

Aakash Healthcare Super Speciality Hospital

City

New Delhi

ZIP/Postal Code

110075

Country

India

Facility Name

Sheba Medical Center

City

Ramat Gan

State/Province

HaMerkaz

ZIP/Postal Code

5262100

Country

Israel

Facility Name

Ha'Emek Medical Center

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Soroka Medical Center

City

Beer Sheva

ZIP/Postal Code

8410101

Country

Israel

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Nagoya Medical Center

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

Fukuyama City Hospital

City

Fukuyama

State/Province

Hiroshima

ZIP/Postal Code

721-8511

Country

Japan

Facility Name

Takeda Dermatology Skincare Clinic

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

004-0063

Country

Japan

Facility Name

National Sagamihara Hospital

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

Japan National Hospital Organization Mie Hospital

City

Tsu-shi

State/Province

Mie

ZIP/Postal Code

514-0125

Country

Japan

Facility Name

Dermatology and Ophthalmology Kume Clinic

City

Sakai City

State/Province

Osaka

ZIP/Postal Code

593-8324

Country

Japan

Facility Name

Senri-Chuo Hanafusa Dermatology Clinic

City

Toyonaka

State/Province

Osaka

ZIP/Postal Code

560-0085

Country

Japan

Facility Name

Dokkyo Medical University Hospital

City

Shimotsuga

State/Province

Tochigi

ZIP/Postal Code

321-0293

Country

Japan

Facility Name

Matsuda Tomoko Dermatological Clinic

City

Fukuoka

ZIP/Postal Code

819-0167

Country

Japan

Facility Name

Shinjuku Minamiguchi Hifuka

City

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Consultorio Privado de la Dra. Villanueva

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44657

Country

Mexico

Facility Name

Hospital Universitario Dr. Jose Eleuterio Gonzalez

City

Monterrey

State/Province

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

CRI Centro Regiomontano de Investigación

City

Monterrey

ZIP/Postal Code

64060

Country

Mexico

Facility Name

Arke Estudios Clinicos S.A. de C.V.

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

Facility Name

Dermed Centrum Medyczne Sp. z o.o.

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Diamond Clinic

City

Krakow

State/Province

Małopolskie

ZIP/Postal Code

31-559

Country

Poland

Facility Name

Centrum Badan Klinicznych PI-House sp. z o.o.

City

Gdansk

State/Province

Pomorskie

ZIP/Postal Code

80-546

Country

Poland

Facility Name

GBUZ Clinical dermatology and venereological dispensary

City

Krasnodar

State/Province

Krasnodarskiy Kray

ZIP/Postal Code

350020

Country

Russian Federation

Facility Name

Scientific Center of Children's Health

City

Moscow

State/Province

Moskva

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Tula Regional Clinical Dermatovenerological Dispensary

City

Tula

State/Province

Tul'skaya Oblast'

ZIP/Postal Code

300053

Country

Russian Federation

Facility Name

Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

Hospital Sant Joan de Déu

City

Esplugues de Llobregat

State/Province

Barcelona [Barcelona]

ZIP/Postal Code

8950

Country

Spain

Facility Name

Hospital Infantil Universitario Niño Jesús

City

Madrid

State/Province

Madrid, Comunidad De

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Univ. Puerta de Hierro

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28220

Country

Spain

Facility Name

Hospital Universitario Quironsalud Madrid

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Clinica Universitaria De Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Clinica Universidad Navarra-Sede Madrid

City

Madrid

ZIP/Postal Code

28022

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Centro de Especialidades Mollabao

City

Pontevedra

ZIP/Postal Code

36001

Country

Spain

Facility Name

Chang Gung Memorial Hospital - Kaohsiung Branch

City

Kaohsiung City

ZIP/Postal Code

833401

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung City

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei City

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei City

ZIP/Postal Code

112201

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Taipei

City

Taipei

ZIP/Postal Code

10508

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Linkou

City

Taoyuan City

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

St Thomas's Hospital

City

Waterloo

State/Province

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Queen's Medical Centre, Nottingham University Hospitals

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Royal Hospital for Children

City

Glasgow

ZIP/Postal Code

G514TF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

http://www.clinicalstudydatarequest.com

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/B796sBY99npuSW6LYeHAk

Description

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis (BREEZE-AD-PEDS)

Learn more about this trial

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

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