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New hope for kids with severe eczema: drug trial shows promise

NCT ID NCT05559359

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a drug called lebrikizumab in children aged 6 months to 18 years with moderate-to-severe eczema (atopic dermatitis). The goal is to see if it improves skin condition and reduces itching compared to a placebo. About 367 participants will receive either the drug or a dummy treatment, and researchers will measure how much the eczema clears up over time.

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

377 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

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

6 months 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: * Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least, * 12 months if participants are ≥6 years of age * 6 months if participants are 2 to \<6 years of age * 3 months if participants are 6 months to \<2 years of age. * Have an EASI score ≥16 at the screening and baseline * Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline * Have ≥10% BSA of AD involvement at the screening and baseline. Exclusion Criteria: * Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study. * Treatment with the following prior to the baseline: * An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer. * Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%. * Treatment with a topical investigational drug within 2 weeks prior to the baseline. * Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.

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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 Eczema

Contacts and locations

Locations

  • "DERMED" Centrum Medyczne Sp. z o.o.

    Lodz, 90-265, Poland

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky, 42301, United States

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534, United States

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72217, United States

  • Arké SMO S.A de C.V

    Veracruz, 91900, Mexico

  • Asahikawa Medical University Hospital

    Asahikawa, 078-8510, Japan

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012, Argentina

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803, Brazil

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

    Gdansk, 80-546, Poland

  • Centrum Medyczne Evimed

    Warsaw, 02-625, Poland

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, 83301, Taiwan

  • Chang Gung Memorial Hospital-Taipei

    Taipei, 105, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Clinica de Alergia Martti Antila

    Sorocaba, 18040-425, Brazil

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209, United States

  • Cornerstone Dermatology

    Coorparoo, 4151, Australia

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • DermEdge Research

    Mississauga, L4Y 4C5, Canada

  • Derma Internacional

    Buenos Aires, 1426, Argentina

  • Dermatologists of Central States, LLC

    Fairborn, Ohio, 45324, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermatology Research Institute

    Calgary, T2J 7E1, Canada

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, 593-8324, Japan

  • Diamond Clinic

    Krakow, 31-559, Poland

  • Enomoto Clinic

    Kumagaya, 360-0018, Japan

  • Eukarya PharmaSite

    Monterrey, 64718, Mexico

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455, Germany

  • Faculdade de Medicina do ABC

    Santo André, 09060-870, Brazil

  • Fakultni nemocnice Bulovka

    Prague, 180 81, Czechia

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • ForCare Clinical Research

    Tampa, Florida, 33613, United States

  • Fujita Health University

    Toyoake, 470-1192, Japan

  • Fukuyama City Hospital

    Fukuyama, 721-8511, Japan

  • Fundacion Estudios Clinicos

    Rosario, S2000DEJ, Argentina

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, 14784400, Brazil

  • Grupo Pedro Jaén

    Madrid, 28006, Spain

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009, Spain

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, 06720, Mexico

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950, Spain

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, 66460, Mexico

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las, 35010, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, 14051-140, Brazil

  • Hospital de Jesús Nazareno

    Mexico City, 06090, Mexico

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180, Brazil

  • Ina Central Hospital

    Ina, 396-0033, Japan

  • Instituto Dermatologico de Jalisco

    Zapopan, 45190, Mexico

  • Instituto de Neumonología Y Dermatología

    Buenos Aires, 1425, Argentina

  • Integrative Skin Science and Research

    Sacramento, California, 95815, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, 252-0392, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu, 300, Taiwan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557, Japan

  • Osaka Habikino Medical Center

    Habikino, 583-8588, Japan

  • PanAmerican Clinical Research - Cuernavaca

    Cuernavaca, 62290, Mexico

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Psoriahue

    Buenos Aires, C1425DKG, Argentina

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520, United States

  • Rady's Children Hospital San Diego - Dermatology

    San Diego, California, 92123, United States

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan, 48197, United States

  • Rosenpark Research GmbH

    Darmstadt, 64283, Germany

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207, Mexico

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256, United States

  • Sugamo Sengoku Dermatology

    Toshima City, 170-0002, Japan

  • Sydney Children's Hospital

    Randwick, 2031, Australia

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • The Children's Hospital at Westmead

    Westmead, 2145, Australia

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Trials in Medicine

    Mexico City, 06700, Mexico

  • UConn Health

    Farmington, Connecticut, 06030-2840, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Veracity Clinical Research

    Woolloongabba, 4102, Australia

More trials for these conditions

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