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

Enrolling by invitation · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis, Eczema

In brief

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.

Key facts

Study ID

NCT05735483

Run by

Eli Lilly and Company

People needed

333

Starts

2023-03-09

Expected to finish

2029-04-01

Last updated by the study team

2026-07-30

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Arkansas Research Trials — North Little Rock, Arkansas, United States
• First OC Dermatology — Fountain Valley, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Integrative Skin Science and Research - Location 2 — Sacramento, California, United States
• UConn Health — Farmington, Connecticut, United States
• Solutions Through Advanced Research — Jacksonville, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Allergy and Asthma Specialist — Owensboro, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Respiratory Medicine Research Institute of Michigan, PLC — Ypsilanti, Michigan, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Wright State Physicians — Fairborn, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The University of Texas Health Science Center at Houston — Bellaire, Texas, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• CONEXA Investigacion Clinica S.A. — Buenos Aires, Buenos Aires, Argentina
• Fundación Respirar — Buenos Aires, Buenos Aires, Argentina
• Instituto de Neumonología Y Dermatología — Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
• Psoriahue — Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
• Clinical Research Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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