Clinical trial NCT03952559: A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: eczema
atopic eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2019-05-16
Enrollment: 516
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement
timeFrame: Week 16
measure: Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
timeFrame: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
measure: Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
timeFrame: Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Secondary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI90
timeFrame: Week 16
measure: Change From Baseline in EASI Score
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
timeFrame: Week 16
measure: Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI50
timeFrame: Week 16
measure: Percentage of Participants Achieving IGA of 0
timeFrame: Week 16
measure: Change From Baseline in SCORAD
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving SCORAD90
timeFrame: Week 16
measure: Change From Baseline in Body Surface Area (BSA) Affected
timeFrame: Baseline, Week 16
measure: Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
timeFrame: Week 16
measure: Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)
timeFrame: Baseline Through 16 Weeks
measure: Mean Gram Quantity of TCS Use (Tube Weights)
timeFrame: Baseline through 16 Weeks
measure: Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry
timeFrame: Baseline, Week 16
measure: Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry
timeFrame: Baseline, Week 16
measure: Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry
timeFrame: Baseline, Week 16
measure: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry
timeFrame: Week 16
measure: Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry
timeFrame: Baseline, Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry
timeFrame: Baseline, Week 16
measure: Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry
timeFrame: Week 2
measure: Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry
timeFrame: Week 2
measure: Height, Weight and Body Mass Index (BMI) Growth Rate
timeFrame: 124 Weeks
measure: Change of Immunoglobulin G (IgG) Titers
timeFrame: Baseline Through End of Study Completion
measure: Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
timeFrame: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
measure: Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
timeFrame: Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Instituto de Neumonología Y Dermatología
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion CIDEA
state: Ciudad Autonoma Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Melbourne
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Vienna
country: Austria
facility: Sozialmedizinisches Zentrum Ost/Donauspital
state: Wien
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: Rio de Janeiro
country: Brazil
facility: IDERJ - Instituto de Dermatologia e Estética do Brasil
city: São Paulo
country: Brazil
facility: Hospital do Servidor Público Estadual - IAMSPE - centro de estudos urológicos
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Hradec Králové
city: Novy Jicin
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s.
state: Nový Jičín
city: Praha
country: Czechia
facility: Fakultni Nemocnice v Motol
state: Praha 5
city: Prague
country: Czechia
facility: Fakultni nemocnice Bulovka
state: Praha 8
city: Praha 2
country: Czechia
facility: Sanatorium profesora Arenbergera
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
state: Alpes-Maritimes
city: Romans-sur-Isere
country: France
facility: Hôpitaux Drôme Nord - Romans
state: Drôme
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
state: Finistère
city: Montpellier
country: France
facility: Chu Saint Eloi
state: Languedoc-Roussillon
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
state: Loire-Atlantique
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey
state: Midi-Pyrénées
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul
state: Nord-Pas-de-Calais
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Hamburg
country: Germany
facility: Katholisches Kinderkrankenhaus Wilhelmstift
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrad
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jasz-Nagykun-Szolnok
city: Dwarka
country: India
facility: Aakash Healthcare: Super Speciality Hospital -Dwarka
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: B. J. Medical College & Civil Hospital
state: Gujarat
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Afula
country: Israel
facility: Emek Medical Center
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Nagoya
country: Japan
facility: Nagoya Medical Center
state: Aichi
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Takeda Dermatology Skincare Clinic
state: Hokkaido
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Tsu
country: Japan
facility: National Mie Hospital
state: Mie
city: Sakai City
country: Japan
facility: Kume Clinic
state: Osaka
city: Toyonaka
country: Japan
facility: Senri-Chuo Hanafusa Dermatology Clinic
state: Osaka
city: Shimotsuga
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Fukuoka
country: Japan
facility: Matsuda Tomoko Dermatological Clinic
city: Tokyo
country: Japan
facility: Shinjuku Minamiguchi Hifuka
city: Guadalajara
country: Mexico
facility: Centro de Atención en Enfermedades Inflamatorias CATEI
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigación
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo León
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Lodz
country: Poland
facility: Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
state: Lodzkie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Małopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Krasnodar
country: Russian Federation
facility: Krasnodar Clinical Skin and Venereal Diseases Dispensary
state: Krasnodarskiy Kray
city: Moscow
country: Russian Federation
facility: Children's Health Research Center of RAMS
state: Moskva
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology - Central branch
state: Moskva
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Dermatovenerological Dispensary
state: Tul'skaya Oblast'
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid, Comunidad De
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Pontevedra
country: Spain
facility: CHOP-Centro De Especialidades De Mollabao
state: Pontevedra [Pontevedra]
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Glasgow City
city: London
country: United Kingdom
facility: St Thomas's Hospital
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre, Nottingham University Hospitals
state: Nottinghamshire
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: