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Enrolling by invitation NCT05735483

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Phase III Interventional Atopic Dermatitis Eczema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lebrikizumab, Placebo.
Who it may be relevant to
Registry conditions: Atopic Dermatitis, Eczema. Basic parameters: 6 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Brazil, Canada +8
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Overview

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

Interventions

  • Drug Lebrikizumab
    Administered SC
  • Drug Placebo
    Administered SC

Primary outcome measures

  • Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) [Time frame: Baseline through Week 52]
Secondary outcome measures (9)
  • Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ [Time frame: Baseline to Week 52]
  • Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ [Time frame: Baseline to Week 52]
  • Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ [Time frame: Baseline to Week 52]
  • Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ [Time frame: Baseline to Week 52]
  • Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score [Time frame: Baseline, Week 52]
  • Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD) [Time frame: Baseline, Week 52]
  • Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI [Time frame: Baseline, Week 52]
  • Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI [Time frame: Baseline, Week 52]
  • Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA) [Time frame: Baseline, Week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 21 centers
  • Clinical Research Center of Alabama — Birmingham
  • Phoenix Children's Hospital — Phoenix
  • Arkansas Research Trials — North Little Rock
  • First OC Dermatology — Fountain Valley
  • Dermatology Research Associates — Los Angeles
  • Integrative Skin Science and Research - Location 2 — Sacramento
  • UConn Health — Farmington
  • Solutions Through Advanced Research — Jacksonville
  • … and 13 more centers
Japan · 12 centers
  • Fujita Health University — Toyoake
  • Fukuyama City Hospital — Fukuyama
  • Hiroshima University Hospital — Hiroshima
  • Asahikawa Medical College Hospital — Asahikawa
  • National Hospital Organization Sagamihara National Hospital — Sagamihara
  • University Hospital,Kyoto Prefectural University of Medicine — Kyoto
  • Ina Central Hospital — Ina
  • Okayama City General Medical Center Okayama City Hospital — Okayama
  • … and 4 more centers
Spain · 10 centers
  • Hospital Sant Joan de Déu — Esplugues de Llobregat
  • Hospital Universitario de Gran Canaria Doctor Negrín — Las
  • … and 8 more centers
Mexico · 9 centers
  • Scientia Investigacion Clinica S.C. — Chihuahua City
  • Instituto Dermatologico de Jalisco — Zapopan
  • Hospital de Jesús Nazareno — Mexico City
  • Trials in Medicine — Mexico City
  • Hospital Infantil de Mexico Federico Gomez — Mexico City
  • PanAmerican Clinical Research - Cuernavaca — Cuernavaca
  • Eukarya PharmaSite — Monterrey
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey
  • … and 1 more center
Brazil · 8 centers
  • IBPClin - Instituto Brasil de Pesquisa Clínica — Rio de Janeiro
  • Hospital de Clinicas de Porto Alegre — Porto Alegre
  • Fundação Pio XII - Hospital de Câncer de Barretos — Barretos
  • Centro de Pesquisa Sao Lucas — Campinas
  • Hospital de Clínicas de Ribeirão Preto — Ribeirão Preto
  • Faculdade de Medicina do ABC — Santo André
  • Pesquisare Saude — Santo André
  • Clinica de Alergia Martti Antila — Sorocaba
Argentina · 7 centers
  • CONEXA Investigacion Clinica S.A. — Buenos Aires
  • Fundación Respirar — Buenos Aires
  • Instituto de Neumonología Y Dermatología — Ciudad Autonoma de Buenos Aire
  • Psoriahue — Ciudad Autonoma de Buenos Aire
  • Centro de Investigaciones Metabólicas (CINME) — Ciudad Autónoma de Buenos Aires
  • Fundacion Cidea — Buenos Aires
  • Fundacion Estudios Clinicos — Rosario
Taiwan · 6 centers

Center list to be confirmed — check the primary protocol.

Germany · 5 centers
  • Rosenpark Research GmbH — Darmstadt
  • Universitätsklinikum Frankfurt — Frankfurt am Main
  • Fachklinik Bad Bentheim — Bad Bentheim
  • Universitätsklinikum Münster — Münster
  • Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
Australia · 4 centers
  • Sydney Children's Hospital — Randwick
  • The Children's Hospital at Westmead — Westmead
  • Cornerstone Dermatology — Coorparoo
  • Veracity Clinical Research Pty Ltd — Woolloongabba
France · 4 centers
  • Hôpitaux Drôme Nord - Romans — Romans-sur-Isère
  • Hôpital Saint Vincent-de-Paul — Lille
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes
  • CHU de Toulouse - Hopital Larrey — Toulouse
Poland · 4 centers
  • Centrum Medyczne Evimed — Warsaw
  • Diamond Clinic — Krakow
  • Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
  • DERMED Centrum Medyczne Sp. z o.o. — Lodz
Canada · 2 centers
  • Dermatology Research Institute — Calgary
  • DermEdge Research — Mississauga
Czechia · 2 centers
  • Detska nemocnice FN Brno — Brno
  • Fakultni nemocnice Bulovka — Prague

Identifiers

NCT: NCT05735483 · 18266 · J2T-MC-KGBJ/DRM06-AD16 · 2022-501478-21-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗