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

JRCT ID: jRCT2031230146

Registered date:16/06/2023

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Atopic Dermatitis
Eczema

• Date of first enrollment: 01/08/2023
• Target sample size: 250
• Countries of recruitment: Argentina,Japan,Australia,Japan,Czechia,Japan,France,Japan,Germany,Japan,Mexico,Japan,Poland,Japan,Spain,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Lebrikizumab
Administered SC
Other Name: LY3650150
Drug: Placebo
Administered SC

Study Arms
Experimental: Lebrikizumab + Placebo
Lebrikizumab will be given subcutaneously (SC).
Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
Interventions:
Drug: Lebrikizumab
Drug: Placebo

Outcome(s)

• Primary Outcome: Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) [ Time Frame: Baseline through Week 52 ]

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: <= 18age old
• Gender: Both

Include criteria

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

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05735483