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 (ADorable-2)

Lilly

Status and phase: Invitation-only; Phase 3

Conditions: Atopic Dermatitis; Eczema

Treatments: Drug: Placebo; Drug: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05735483

2022-501478-21-00 (Other Identifier)

J2T-MC-KGBJ/DRM06-AD16 (Other Identifier)

18266

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion 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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Lebrikizumab

Experimental group

Description:

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

Treatment:

Drug: Lebrikizumab

Drug: Placebo

Lebrikizumab - Optional Extension Period (OEP)

Experimental group

Description:

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

Treatment:

Drug: Lebrikizumab