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New pill could help kids with severe eczema

NCT ID NCT03952559

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 06, 2026 · Updated 4 times

Summary

This study tests whether baricitinib, an oral anti-inflammatory drug, is safe and effective for children aged 2 to 17 with moderate to severe atopic dermatitis (eczema). About 516 participants will receive either baricitinib or a placebo, along with standard topical steroids. The main goal is to see if the drug clears skin or reduces eczema severity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baricitinib (an oral drug that targets inflammation)
What this could lead to
If it works, this could provide a new treatment option for children with moderate to severe eczema that hasn't responded to topical creams.
What could go wrong
This is a late-stage trial, but baricitinib is already approved for adults with eczema. However, results in children may differ, and side effects like infections or blood clots are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

516 people

The number who actually took part.

Started

May 2019

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Aakash Healthcare: Super Speciality Hospital -Dwarka

    Dwarka, National Capital Territory of Delhi, 110075, India

  • Allergo-Derm Bakos Kft

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • Arké SMO S.A de C.V

    Veracruz, 91900, Mexico

  • B. J. Medical College & Civil Hospital

    Ahmedabad, Gujarat, 380016, India

  • CHOP-Centro De Especialidades De Mollabao

    Pontevedra, Pontevedra [Pontevedra], 36001, Spain

  • CHU de Toulouse - Hopital Larrey

    Toulouse, Midi-Pyrénées, 31400, France

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

    Brest, Finistère, 29200, France

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

    Nantes, Loire-Atlantique, 44093, France

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, Alpes-Maritimes, 6200, France

  • Centro Regiomontano de Investigación

    Monterrey, Nuevo León, 64060, Mexico

  • Centro de Atención en Enfermedades Inflamatorias CATEI

    Guadalajara, Jalisco, 44638, Mexico

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1027, Argentina

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

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Children's Health Research Center of RAMS

    Moscow, Moscow, 115478, Russia

  • Chu Saint Eloi

    Montpellier, Languedoc-Roussillon, 34295, France

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Diamond Clinic

    Krakow, Lesser Poland Voivodeship, 31-559, Poland

  • Dokkyo Medical University Hospital

    Shimotsuga, Tochigi, 321-0293, Japan

  • Emek Medical Center

    Afula, Northern District, 1834111, Israel

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-870, Brazil

  • Fakultni Nemocnice v Motol

    Prague, Praha 5, 150 06, Czechia

  • Fakultni nemocnice Bulovka

    Prague, Praha 8, 180 81, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05, Czechia

  • Fukuyama City Hospital

    Fukuyama, Hiroshima, 721-8511, Japan

  • Fundacion CIDEA

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1121ABE, Argentina

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009, Spain

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona], 8950, Spain

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 66460, Mexico

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Comunidad de, 28222, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital do Servidor Público Estadual - IAMSPE - centro de estudos urológicos

    São Paulo, 04039-901, Brazil

  • Hôpital Saint Vincent de Paul

    Lille, Hauts-de-France, 59020, France

  • Hôpitaux Drôme Nord - Romans

    Romans-sur-Isère, Drôme, 26102, France

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 22241-180, Brazil

  • IDERJ - Instituto de Dermatologia e Estética do Brasil

    Rio de Janeiro, 22470-220, Brazil

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000, Mexico

  • Instituto de Neumonología Y Dermatología

    Capital Federal, Buenos Aires, 1425, Argentina

  • Katholisches Kinderkrankenhaus Wilhelmstift

    Hamburg, 22149, Germany

  • Krasnodar Clinical Skin and Venereal Diseases Dispensary

    Krasnodar, Krasnodarskiy Kray, 354057, Russia

  • Kume Clinic

    Sakai, Osaka, 593-8324, Japan

  • Matsuda Tomoko Dermatological Clinic

    Fukuoka, 819-0167, Japan

  • Medizinische Universität Graz

    Graz, Styria, 8036, Austria

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090, Austria

  • Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology - Central branch

    Moscow, Moscow, 127473, Russia

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa, 252-0392, Japan

  • National Mie Hospital

    Tsu, Mie-ken, 514-0125, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín, Nový Jičín, 741 01, Czechia

  • Queen's Medical Centre, Nottingham University Hospitals

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

  • Royal Children's Hospital

    Melbourne, Victoria, 3052, Australia

  • Royal Hospital for Sick Children

    Glasgow, Glasgow City, G514TF, United Kingdom

  • Sanatorium profesora Arenbergera

    Prague, 128 00, Czechia

  • Senri-Chuo Hanafusa Dermatology Clinic

    Toyonaka, Osaka, 560-0085, Japan

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100, Israel

  • Shinjuku Minamiguchi Hifuka

    Tokyo, 160-0023, Japan

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Soroka Medical Center

    Beersheba, Southern District, 8410101, Israel

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb, 6423906, Israel

  • Sozialmedizinisches Zentrum Ost/Donauspital

    Vienna, State of Vienna, 1220, Austria

  • Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

    Lodz, Łódź Voivodeship, 90-265, Poland

  • St Thomas's Hospital

    London, London, City of, SE1 7EH, United Kingdom

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád megye, 6720, Hungary

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Takeda Dermatology Skincare Clinic

    Sapporo, Hokkaido, 004-0063, Japan

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • Tula Regional Clinical Dermatovenerological Dispensary

    Tula, Tula Oblast, 300053, Russia

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590, Germany

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Veracity Clinical Research

    Woolloongabba, Queensland, 4102, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.