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Enrolling by invitationPhase 3

Long-term study of lebrikizumab in children with atopic dermatitis

Tests lebrikizumab over time in children aged 6 months to under 18 with eczema.

Key facts

Who runs it
Eli Lilly and Company
Where
Buenos Aires, Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aires, and Rosario, ArgentinaSee the 7 sitesAlso in 12 other countries, 86 sites
Trial code
Registry title
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
Status
Enrolling by invitation
Phase
Phase 3
People taking part
338 people, planned
Started
9 Mar 2023
Expected to end
Apr 2029
Type of study
Interventional, 2 groups
Treatments tested
  • Lebrikizumab
  • Placebo
Record updated
26 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with moderate-to-severe atopic dermatitis who already finished the earlier study KGBI and now continue lebrikizumab treatment.

Age
6 Months to under 18 Years
Sex
All sexes can join.
Disease stage
Moderate-to-severe atopic dermatitis.
Earlier treatment
Must have been treated in study KGBI and completed its treatments and last visit, including any washout of systemic atopic dermatitis treatment.

Main reasons for not taking part

  • A serious side effect in study KGBI judged related to lebrikizumab
  • A side effect in study KGBI related to lebrikizumab that led to stopping treatment
  • Met the criteria for permanent treatment stop in study KGBI, if related to lebrikizumab or led to withdrawal from the study
  • Pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Argentina

Also in 12 other countries, 86 sites

  • CONEXA Investigacion Clinica S.A.Buenos Aires, ArgentinaNo longer taking part
  • Fundacion CideaBuenos Aires, ArgentinaNo longer taking part
  • Fundacion RespirarBuenos Aires, ArgentinaNo longer taking part
  • Instituto de Neumonología Y DermatologíaCiudad Autonoma de Buenos Aire, ArgentinaNo longer taking part
  • PsoriahueCiudad Autonoma de Buenos Aire, ArgentinaNo longer taking part
  • Centro de Investigaciones Metabólicas (CINME)Ciudad Autónoma de Buenos Aires, ArgentinaNo longer taking part
  • Fundacion Estudios ClinicosRosario, ArgentinaNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • LebrikizumabTreatment being tested

    Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.

    Treatment: Lebrikizumab and Placebo

  • Lebrikizumab - Optional Extension Period (OEP)Treatment being tested

    During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.

    Treatment: Lebrikizumab and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Long-term study of lebrikizumab in children with atopic dermatitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
26 October 2026