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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

NCT05735483

Enrolling By InvitationPhase 3

Sponsor: Eli Lilly and Company

Conditions: Atopic Dermatitis, Eczema

Interventions: Lebrikizumab, Placebo

Countries: United States, Argentina, Australia, Brazil, Canada, Czechia, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 6 Months to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (94)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
North Little Rock, Arkansas, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Farmington, Connecticut, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Owensboro, Kentucky, United States
Boston, Massachusetts, United States
Bay City, Michigan, United States
Ypsilanti, Michigan, United States
Lebanon, New Hampshire, United States
Fairborn, Ohio, United States
Charleston, South Carolina, United States
Bellaire, Texas, United States
San Antonio, Texas, United States
Milwaukee, Wisconsin, United States
Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Rosario, Santa Fe Province, Argentina
Randwick, New South Wales, Australia
Westmead, New South Wales, Australia
+ 64 more on CT.gov