J2T-MC-KGBI/DRM06-AD13: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis

The primary objective of this study is to evaluate the **efficacy** of **lebrikizumab** when used in combination with topical corticosteroid (TCS) treatment, compared with placebo, in participants aged 6 months to less than 18 years with moderate-to-severe **atopic dermatitis**. This is clinically relevant as it aims to determine the potential of lebrikizumab to improve the management of atopic dermatitis, a chronic inflammatory skin condition, in a pediatric population. The study also encompasses several trial scopes, including the assessment of safety, pharmacokinetics, and the identification of biomarkers, which are crucial for understanding the broader implications of lebrikizumab treatment in this demographic.

The clinical trial involves a total of **271 participants** diagnosed with **Atopic Dermatitis**, also known as eczema. The study population includes both male and female subjects, with an age range from 6 months to 18 years. Participants are required to have had Atopic Dermatitis for at least 6 months if they are younger than 6 years old, or for 1 year if they are older than 6 years. The trial includes individuals who weigh over 6 kilograms if they are between 6 months to 6 years old, and those who weigh less than 40 kilograms if they are between 12 to 18 years old. The selection process ensures that a parent or legal guardian is able to sign the consent document and adhere to the study guidelines. The trial population is characterized by a vulnerable group, considering the inclusion of minors. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. The study aims to evaluate the efficacy of lebrikizumab in combination with TCS treatment compared to a placebo in participants with moderate-to-severe Atopic Dermatitis.

The clinical trial is designed as a **randomized, double-blind, placebo-controlled** study to evaluate the efficacy, safety, and pharmacokinetics of **lebrikizumab** in combination with topical corticosteroid (TCS) treatment in participants aged 6 months to less than 18 years with moderate-to-severe **atopic dermatitis**. The trial is a Phase 3 study, with an estimated recruitment start date of September 1, 2023, and an estimated end date of June 15, 2025. The trial will involve multiple study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age, weight, and medical history. Participants must have had atopic dermatitis for at least 6 months if younger than 6 years or 1 year if older than 6 years. The primary endpoints include the percentage of participants achieving an Investigator Global Assessment (IGA) score of 0 or 1 with a reduction of at least 2 points from baseline, and the percentage achieving a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75).

Following the screening visit, eligible participants will be randomized to receive either lebrikizumab or a placebo, administered via **subcutaneous injection**. The trial will include regular follow-up visits to monitor the participants' response to treatment, assess safety, and collect pharmacokinetic data. The maximum treatment period for lebrikizumab is 16 weeks. Participants will also receive TCS treatment as part of the study protocol. The trial will conclude with an end-of-study visit to evaluate the overall outcomes and any adverse events. The expected length of participant involvement is approximately 16 weeks, with conditions for early termination including significant adverse reactions or withdrawal of consent. The study aims to provide comprehensive data on the efficacy and safety of lebrikizumab in the specified pediatric population with atopic dermatitis.

The clinical trial involves the administration of **Lebrikizumab**, a monoclonal antibody, as the experimental medication. Lebrikizumab is provided in a **solution for injection** form and is administered via **subcutaneous injection**. The treatment period for Lebrikizumab is up to 16 weeks. The dosing schedule and specific dosage amounts are not specified in the provided data. Participant compliance with the administration schedule will be monitored throughout the trial.

In addition to the experimental medication, a **placebo** is used as a comparator treatment. The placebo is designed to match the appearance and administration route of Lebrikizumab, ensuring blinding in the study. The placebo is administered in the same manner as Lebrikizumab, via subcutaneous injection, over a similar treatment period.

Several non-experimental treatments are also included in the study. These include **glucocorticoids**, which are administered **orally** with a maximum daily dose of 48 mg and a total maximum dose of 1440 mg over a 30-day period. **Other immunosuppressants** are administered orally as well, with a maximum daily dose of 20 mg and a total maximum dose of 240 mg over a 12-week period.

Topical treatments include **corticosteroids** of varying potencies. **Corticosteroids, weak (Group I)**, **moderately potent (Group II)**, **potent (Group III)**, and **very potent (Group IV)** are all administered topically. Each of these topical treatments has a maximum daily dose of 1 unit and a total maximum dose of 126 units over an 18-week period. Additionally, **agents for dermatitis, excluding corticosteroids**, are also administered topically with the same dosing schedule as the corticosteroids.

Participant compliance with the dosing schedules for both experimental and non-experimental treatments will be closely monitored to ensure adherence to the study protocol. The trial aims to evaluate the efficacy and safety of Lebrikizumab in combination with these treatments in participants with moderate-to-severe atopic dermatitis.

The efficacy of **lebrikizumab** in combination with topical corticosteroid (TCS) treatment will be assessed in a randomized, double-blind, placebo-controlled, Phase 3 clinical trial involving participants aged 6 months to less than 18 years with moderate-to-severe atopic dermatitis. The primary endpoints for evaluating efficacy include the percentage of participants achieving an Investigator Global Assessment (IGA) score of 0 or 1 with a reduction of at least 2 points from baseline, and the percentage of participants achieving a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75) score.

These efficacy parameters will be measured at specified timepoints throughout the trial. The IGA and EASI scores are validated scales commonly used in dermatological studies to assess the severity and extent of atopic dermatitis. The trial is designed to ensure rigorous data collection and analysis, adhering to established clinical trial protocols. The study aims to provide comprehensive insights into the efficacy of lebrikizumab as a treatment option for this patient population.