A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
Study Purpose
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.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 2 Years - 17 Years |
| Gender | All |
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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03952559 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
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) |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Austria, Brazil, Czechia, France, Germany, Hungary, India, Israel, Japan, Mexico, Poland, Russian Federation, Spain, Taiwan, United Kingdom |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Atopic Dermatitis |
| Study Website: | View Trial Website |
Arms
Experimental: Baricitinib Open Label High Dose
Baricitinib administered orally.
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Experimental: Baricitinib Mid Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Placebo Comparator: Placebo
Placebo administered orally. Matching placebo administered orally to maintain the blind.
Interventions
Drug: - Baricitinib
Administered orally
Drug: - Placebo
Administered orally
Drug: - Topical corticosteroid
Administered as standard-of-care
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Active, not recruiting
Address
Centro de Investigaciones Metabólicas (CINME)
Caba, Buenos Aires, C1027AAP
Status
Active, not recruiting
Address
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425BEA
Status
Active, not recruiting
Address
Centro Medico Dra. De Salvo
Capital Federal, , C1426ABP
Status
Active, not recruiting
Address
Fundacion CIDEA
Ciudad Autonoma Buenos Aires, , C1121ABE
Status
Active, not recruiting
Address
The Sydney Children's Hospitals Network
Westmead, New South Wales, 2145
Status
Active, not recruiting
Address
Veracity Clinical Research
Woolloongabba, Queensland, 4102
Status
Active, not recruiting
Address
Royal Children's Hospital
Melbourne, Victoria, 3052
Status
Active, not recruiting
Address
Universitätsklinikum Graz
Graz, Steiermark, 8036
Status
Completed
Address
Medizinische Universität Wien
Wien, Vienna, 1090
Status
Active, not recruiting
Address
Sozialmedizinisches Zentrum Ost/Donauspital
Vienna, Wien, 1220
Status
Active, not recruiting
Address
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, 90035-903
Status
Active, not recruiting
Address
Fundação Faculdade de Medicina do ABC
Santo André, Sao Paulo, 09060-650
Status
Active, not recruiting
Address
Instituto Brasil de Pesquisa Clínica - IBPCLIN
Rio de Janeiro, , 20241180
Status
Active, not recruiting
Address
IDERJ - Instituto de Dermatologia e Estética do Brasil
Rio de Janeiro, , 22470-220
Status
Active, not recruiting
Address
Hospital de Servidor Publico Estadual
São Paulo, , 04039-901
Status
Active, not recruiting
Address
Fakultni Nemocnice v Motole
Praha 5, Hl. M. Praha, 150 06
Status
Active, not recruiting
Address
Fakultni nemocnice Bulovka
Praha 8, Hl. M. Praha, 180 81
Status
Active, not recruiting
Address
Nemocnice AGEL Novy Jicin a.s.
Novy Jicin, Moravskoslezsky Kraj, 741 01
Status
Active, not recruiting
Address
Fakultni nemocnice Hradec Kralove
Hradec Kralove, , 500 05
Status
Completed
Address
Sanatorium profesora Arenbergera
Praha 2, , 128 00
Status
Active, not recruiting
Address
Hopital Saint Eloi
Montpellier Cédex 05, Montpellier, 34295
Status
Active, not recruiting
Address
CHRU de Brest - Hôpital Morvan
Brest, , 29200
Status
Active, not recruiting
Address
Hôpital Saint Vincent de Paul
Lille, , 59020
Status
Active, not recruiting
Address
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes Cedex 1, , 44093
Status
Completed
Address
CHU de Nice Hopital de L'Archet
Nice, , 06202
Status
Active, not recruiting
Address
Hopitaux Drome-Nord
Romans-sur-Isere, , 26102
Status
Active, not recruiting
Address
Hopital Larrey
Toulouse, , 31059
Status
Active, not recruiting
Address
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hessen, 60596
Status
Active, not recruiting
Address
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen, 48149
Status
Active, not recruiting
Address
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, 01307
Status
Active, not recruiting
Address
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg, , 22149
Status
Active, not recruiting
Address
SZTE AOK Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrad, 6720
Status
Active, not recruiting
Address
Allergo-Derm Bakos Kft
Szolnok, Jasz-Nagykun-Szolnok, 5000
Status
Recruiting
Address
All India Institute of Medical Sciences
New Delhi, Delhi, 110029
Status
Recruiting
Address
Sir Ganga Ram Hospital
New Delhi, Delhi, 110060
Status
Recruiting
Address
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016
Status
Recruiting
Address
Thalassemia and Sickle Cell Centre Rughwani Child Care Center and Hospital
Nagpur, Maharashtra, 44001
Status
Recruiting
Address
Dr. D. Y. Patil Medical College & Hospital
Navi Mumbai, Maharashtra, 400706
Status
Recruiting
Address
Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, 442004
Status
Recruiting
Address
Lady Harding Medical College & Hospital
Delhi, New Delhi, 110001
Status
Recruiting
Address
Lifepoint Multispecialty Hsptl
Wakad, Pune, 411057
Status
Recruiting
Address
Postgraduate Institute of Medical Education & Research
Chandigarh, Punjab, 160012
Status
Recruiting
Address
Aakash Healthcare Super Speciality Hospital
New Delhi, , 110075
Status
Active, not recruiting
Address
Sheba Medical Center
Ramat Gan, HaMerkaz, 5262100
Status
Active, not recruiting
Address
Ha'Emek Medical Center
Afula, , 1834111
Status
Active, not recruiting
Address
Soroka Medical Center
Beer Sheva, , 8410101
Status
Active, not recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, , 6423906
Status
Active, not recruiting
Address
Nagoya Medical Center
Nagoya, Aichi, 460-0001
Status
Active, not recruiting
Address
Fukuyama City Hospital
Fukuyama, Hiroshima, 721-8511
Status
Active, not recruiting
Address
Takeda Dermatology Skincare Clinic
Sapporo, Hokkaido, 004-0063
Status
Active, not recruiting
Address
National Sagamihara Hospital
Sagamihara, Kanagawa, 252-0392
Status
Active, not recruiting
Address
Japan National Hospital Organization Mie Hospital
Tsu-shi, Mie, 514-0125
Status
Active, not recruiting
Address
Dermatology and Ophthalmology Kume Clinic
Sakai City, Osaka, 593-8324
Status
Active, not recruiting
Address
Senri-Chuo Hanafusa Dermatology Clinic
Toyonaka, Osaka, 560-0085
Status
Active, not recruiting
Address
Dokkyo Medical University Hospital
Shimotsuga, Tochigi, 321-0293
Status
Active, not recruiting
Address
Matsuda Tomoko Dermatological Clinic
Fukuoka, , 819-0167
Status
Active, not recruiting
Address
Shinjuku Minamiguchi Hifuka
Tokyo, , 160-0023
Status
Active, not recruiting
Address
Consultorio Privado de la Dra. Villanueva
Guadalajara, Jalisco, 44657
Status
Active, not recruiting
Address
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, NL, 64460
Status
Active, not recruiting
Address
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , 34000
Status
Active, not recruiting
Address
CRI Centro Regiomontano de Investigación
Monterrey, , 64060
Status
Active, not recruiting
Address
Arke Estudios Clinicos S.A. de C.V.
Veracruz, , 91910
Status
Active, not recruiting
Address
Dermed Centrum Medyczne Sp. z o.o.
Lodz, Lodzkie, 90-265
Status
Active, not recruiting
Address
Diamond Clinic
Krakow, Małopolskie, 31-559
Status
Active, not recruiting
Address
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomorskie, 80-546
Status
Active, not recruiting
Address
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, Krasnodarskiy Kray, 350020
Status
Active, not recruiting
Address
Scientific Center of Children's Health
Moscow, Moskva, 119991
Status
Active, not recruiting
Address
Tula Regional Clinical Dermatovenerological Dispensary
Tula, Tul'skaya Oblast', 300053
Status
Active, not recruiting
Address
Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology
Moscow, , 127473
Status
Active, not recruiting
Address
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 8950
Status
Active, not recruiting
Address
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad De, 28009
Status
Active, not recruiting
Address
Hospital Univ. Puerta de Hierro
Majadahonda, Madrid, 28220
Status
Active, not recruiting
Address
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid, 28223
Status
Active, not recruiting
Address
Clinica Universitaria De Navarra
Pamplona, Navarra, 31008
Status
Active, not recruiting
Address
Clinica Universidad Navarra-Sede Madrid
Madrid, , 28022
Status
Active, not recruiting
Address
Hospital Universitario La Paz
Madrid, , 28046
Status
Active, not recruiting
Address
Centro de Especialidades Mollabao
Pontevedra, , 36001
Status
Active, not recruiting
Address
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , 833401
Status
Active, not recruiting
Address
Chung Shan Medical University Hospital
Taichung City, , 40201
Status
Active, not recruiting
Address
National Taiwan University Hospital
Taipei City, , 10048
Status
Active, not recruiting
Address
Taipei Veterans General Hospital
Taipei City, , 112201
Status
Active, not recruiting
Address
Chang Gung Memorial Hospital - Taipei
Taipei, , 10508
Status
Active, not recruiting
Address
Chang Gung Memorial Hospital - Linkou
Taoyuan City, , 33305
Status
Active, not recruiting
Address
St Thomas's Hospital
Waterloo, London, SE1 7EH
Status
Active, not recruiting
Address
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, Nottinghamshire, NG7 2UH
Status
Active, not recruiting
Address
Royal Hospital for Children
Glasgow, , G514TF
