A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

The primary objective of this study is to evaluate the **efficacy** of rocatinlimab compared with placebo at week 24, specifically assessed using the Eczema Area and Severity Index (EASI). This is clinically relevant as it aims to determine the potential of rocatinlimab in reducing the severity of atopic dermatitis, a chronic inflammatory skin condition, thereby improving patient outcomes.

Secondary objectives include:

• Evaluating the efficacy of rocatinlimab compared with placebo, assessed using EASI.
• Assessing the efficacy of rocatinlimab compared with placebo on the patient-reported outcome (PRO) measure of pruritus.
• Evaluating the efficacy of rocatinlimab compared with placebo at week 24, assessed using EASI.
• Assessing the efficacy of rocatinlimab compared with placebo at week 24 on the PRO measure of atopic dermatitis skin pain.
• Evaluating the efficacy of rocatinlimab compared with placebo at week 24 with an additional assessment of morphology.

The clinical trial involves a total of **357 participants** diagnosed with **Atopic Dermatitis**. The study population includes both **males and females** aged 12 to less than 18 years, who have been diagnosed with atopic dermatitis for at least 12 months prior to the signing of informed consent. Participants were selected based on a history of inadequate response to topical corticosteroids (TCS) of medium to higher potency, or for whom topical treatments are medically inadvisable due to side effects or safety risks. The trial includes individuals with moderate-to-severe atopic dermatitis, as determined by specific scoring criteria, and requires an Eczema Area and Severity Index (EASI) score of 12 or higher at initial screening and 16 or higher at the day 1 prerandomization visit. The study population is considered vulnerable, and the trial does not specify any particular lifestyle considerations such as diet or physical activity. The selection criteria ensure that participants have a significant disease burden, making them suitable for evaluating the efficacy of the investigational treatment.

The clinical trial is a **Phase 3**, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of **rocatinlimab** (AMG 451) in adolescent subjects with moderate-to-severe **atopic dermatitis**. The trial is set to last for 52 weeks, with an estimated recruitment start date of June 1, 2023, and an estimated end date of December 18, 2025. Participants will be randomly assigned to receive either rocatinlimab or a placebo, with rerandomization occurring during the study to further assess the treatment's effects.

The study will include several key visits: an initial **screening visit** to determine eligibility based on inclusion criteria such as age, diagnosis, and previous treatment response; a **prerandomization visit** on day 1 to confirm the presence of moderate-to-severe atopic dermatitis; and multiple **follow-up visits** to monitor the participants' progress and collect data on primary and secondary endpoints. The primary endpoint is achieving a pre-determined score at week 24, while secondary endpoints include changes in the Eczema Area and Severity Index (EASI) and pruritus scores.

Participants are expected to be involved in the trial for the full 52-week duration unless specific conditions necessitate early termination. Such conditions may include adverse events, withdrawal of consent, or failure to adhere to the study protocol. The trial aims to provide comprehensive data on the potential benefits and risks of rocatinlimab in treating adolescent atopic dermatitis, contributing valuable insights into its clinical application.

The clinical trial involves the evaluation of **Rocatinlimab** (AMG 451), a test medication developed by AMGEN INC. Rocatinlimab is a protein-based therapeutic agent, classified under the category of "Protein - Other." It is administered to participants in a pharmaceutical form that is not specified in the provided data. The trial aims to assess the efficacy, safety, and tolerability of Rocatinlimab in adolescent subjects with moderate-to-severe **Atopic Dermatitis**. The dosing schedule, route, and frequency of administration are not detailed in the available information.

In addition to Rocatinlimab, the study includes a **placebo** as a comparator treatment. The placebo is used to provide a control group for evaluating the effects of the experimental medication. The placebo is administered in a manner consistent with the experimental treatment to maintain the double-blind nature of the study. Specific details regarding the pharmaceutical form, dosage, and administration route of the placebo are not provided.

Two auxiliary products are also mentioned in the trial documentation, identified by the scientific product evaluation codes L04A and D07A. These products are not the primary focus of the study and are likely used to support the trial procedures. The exact role, dosage, and administration details of these auxiliary products are not specified in the data.

The efficacy of rocatinlimab (AMG 451) in the treatment of moderate-to-severe **Atopic Dermatitis** (AD) will be assessed in a Phase 3, randomized, placebo-controlled, double-blind clinical trial. The primary endpoint for evaluating efficacy is achieving a pre-determined score at week 24. Secondary endpoints include achieving a pre-determined reduction from baseline in the Eczema Area and Severity Index (EASI) at week 24, as well as improvements in the weekly average of daily worst pruritus numeric rating scale (NRS) score and AD skin pain NRS score at week 24.

Efficacy assessments will be conducted using validated scales such as the EASI and NRS, with measurements taken at specified timepoints, including initial screening, day 1 prerandomization, and week 24. The trial will involve adolescent subjects aged 12 to less than 18 years with a diagnosis of AD, who have shown an inadequate response to topical corticosteroids (TCS) of medium to higher potency or for whom topical treatments are medically inadvisable. The study aims to provide a comprehensive evaluation of the efficacy of rocatinlimab compared to placebo, with a focus on symptom improvement and disease activity reduction.