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 - J2T-MC-KGBJ/DRM06-AD16

Masaki Takeshi0 sites250 target enrollmentJune 16, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 16, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Masaki Takeshi

•Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI.
•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

•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.