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New eczema drug shows promise for kids in Long-Term trial

NCT ID NCT05735483

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at the long-term safety and effectiveness of lebrikizumab for children aged 6 months to under 18 years with moderate-to-severe atopic dermatitis (eczema). About 310 participants who completed a prior study will receive lebrikizumab for up to 116 weeks. The goal is to see if the drug can control eczema symptoms over time with an acceptable safety profile.

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

About 333 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Apr 2029

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 18 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: * Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout. * For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: * Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. * Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. * Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.) Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab. * Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    94 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allergy and Asthma Specialist

    Owensboro, Kentucky, 42301, United States

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72217, United States

  • Arké SMO S.A de C.V

    Veracruz, Veracruz, 91910, Mexico

  • Asahikawa Medical College Hospital

    Asahikawa, Hokkaido, 078-8510, Japan

  • CHOP-Centro De Especialidades De Mollabao

    Pontevedra, Pontevedra [Pontevedra], 36001, Spain

  • CHU de Toulouse - Hopital Larrey

    Toulouse, Midi-Pyrénées, 31400, France

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, Buenos Aires, 1012, Argentina

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

    Nantes, Loire-Atlantique, 44093 Cedex 1, France

  • Centro de Investigaciones Metabólicas (CINME)

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

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo, 13060-803, Brazil

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

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Centrum Medyczne Evimed

    Warsaw, Masovian Voivodeship, 02-625, Poland

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, Taichung, 402, Taiwan

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinica de Alergia Martti Antila

    Sorocaba, São Paulo, 18040-425, Brazil

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209, United States

  • Cornerstone Dermatology

    Coorparoo, Queensland, 4151, Australia

  • DERMED Centrum Medyczne Sp. z o.o.

    Lodz, Łódź Voivodeship, 90-265, Poland

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • DermEdge Research

    Mississauga, Ontario, L4Y 4C5, Canada

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1, Canada

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324, Japan

  • Detska nemocnice FN Brno

    Brno, Brno-město, 613 00, Czechia

  • Diamond Clinic

    Krakow, Małopolski, 31-559, Poland

  • Enomoto Clinic

    Kumagaya, Saitama, 360-0018, Japan

  • Eukarya PharmaSite

    Monterrey, Nuevo León, 64718, Mexico

  • Fachklinik Bad Bentheim

    Bad Bentheim, Niedersach, 48455, Germany

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-870, Brazil

  • Fakultni nemocnice Bulovka

    Prague, Praha 8, 180 81, Czechia

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • ForCare Clinical Research

    Tampa, Florida, 33613, United States

  • Fujita Health University

    Toyoake, Aichi-ken, 470-1192, Japan

  • Fukuyama City Hospital

    Fukuyama, Hiroshima, 721-8511, Japan

  • Fundacion Cidea

    Buenos Aires, Buenos Aires F.D., C1121ABE, Argentina

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Fundación Respirar

    Buenos Aires, Buenos Aires, C1426ABP, Argentina

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784400, Brazil

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706, United States

  • Grupo Pedro Jaén

    Madrid, Madrid, 28006, Spain

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, 28009, Spain

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, Mexico City, 06720, Mexico

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460, Mexico

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las, Las Palmas, 35010, Spain

  • Hospital de Clinicas de Porto Alegre

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

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital de Jesús Nazareno

    Mexico City, Mexico City, 06090, Mexico

  • Hospital de Manises

    Manises, València, 46940, Spain

  • 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, Rio de Janeiro, 20241-180, Brazil

  • Ina Central Hospital

    Ina, Nagano, 396-0033, Japan

  • Instituto Dermatologico de Jalisco

    Zapopan, Jalisco, 45190, Mexico

  • Instituto de Neumonología Y Dermatología

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1425, Argentina

  • Integrative Skin Science and Research - Location 2

    Sacramento, California, 95815, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, 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, Kanagawa, 252-0315, Japan

  • National Taiwan University Hospital

    Taipei, Taipei, 10002, Taiwan

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu, Hsinchu, 300, Taiwan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, Okayama-ken, 700-8557, Japan

  • Osaka Habikino Medical Center

    Habikino, Osaka, 583-8588, Japan

  • PanAmerican Clinical Research - Cuernavaca

    Cuernavaca, Morelos, 62290, Mexico

  • Pesquisare Saude

    Santo André, São Paulo, 09080-110, Brazil

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Psoriahue

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425DKG, Argentina

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan, 48197, United States

  • Rosenpark Research GmbH

    Darmstadt, Hesse, 64283, Germany

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, Chihuahua, 31207, Mexico

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256, United States

  • Sugamo Sengoku Dermatology

    Toshima City, Tokyo, 170-0002, Japan

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031, Australia

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217, Taiwan

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Trials in Medicine

    Mexico City, Mexico City, 06700, Mexico

  • UConn Health

    Farmington, Connecticut, 06030, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307, Germany

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590, Germany

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102, Australia

  • Wright State Physicians

    Fairborn, Ohio, 45324, United States

More trials for these conditions

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