Long-Term Safety and Efficacy of Lebrikizumab in Pediatric Patients With Moderate-to-Severe Atopic Dermatitis

The primary objective is to describe the long-term safety of lebrikizumab in participants aged 6 months to <18 years with moderate-to-severe atopic dermatitis. This assessment will inform the safety profile of the IL‑13‑targeted monoclonal antibody in a pediatric population, supporting risk‑benefit evaluation for chronic use.

The trial enrolled 178 pediatric participants diagnosed with moderate-to-severe atopic dermatitis who were eligible for evaluation of the long‑term safety of lebrikizumab. Children were approximately 2 years of age and included both females and males, reflecting a vulnerable population due to their age. Selection required prior receipt and completion of treatment in study J2T‑MC‑KGBI. No specific lifestyle restrictions such as diet or physical activity were stipulated. Key inclusion criteria centered on previous participation in the referenced study; additional exclusion criteria were not detailed.

The study is a Phase III, multicenter, long‑term extension evaluating the safety and efficacy of lebrikizumab in pediatric participants aged 6 months to <18 years with moderate‑to‑severe atopic dermatitis. Participants who completed the preceding trial are enrolled in a double‑blind, placebo‑controlled design, receiving either lebrikizumab (solution for injection) or a matching placebo. The protocol includes an initial screening visit to confirm eligibility, a baseline visit at which study medication is first administered, regular follow‑up visits (typically every 12 weeks) to assess adverse events, laboratory parameters, and disease severity, and a final end‑of‑study visit after the planned treatment period. The overall trial duration spans from December 2023 to April 2029, with each participant remaining in the study for up to five years. The primary endpoint is the percentage of participants discontinuing treatment because of adverse events. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, or fails to meet continued eligibility criteria.

Lebrikizumab is the investigational product administered in this study. It is provided as a solution for injection in a pre‑filled syringe. The designated route of administration is subcutaneous injection (solution for injection). The protocol specifies a dose of 0 Other, as indicated in the study documentation. Dosing is performed according to the study schedule, which outlines the frequency and timing of each administration.

The comparator is a placebo formulated to match LY3650150. No active substance is present, and the product is described as not applicable (N/A) for pharmaceutical form, route, dose, and dose unit. The placebo is administered in the same manner and schedule as the investigational product to maintain blinding.

All study participants receive the assigned treatment—either lebrikizumab or matching placebo—according to the predefined dosing schedule. Administration is performed by qualified study personnel, and adherence to the dosing regimen is monitored through study visit records and compliance checks documented in the trial case report forms. The trial enrolls pediatric participants aged 6 months to < 18 years with moderate-to‑severe Atopic dermatitis, and safety assessments are conducted throughout the long‑term extension phase.