A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

The primary objective of this study is to evaluate the efficacy of rocatinlimab compared to placebo in adult subjects with moderate-to-severe atopic dermatitis at week 24, utilizing the Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) and the Eczema Area and Severity Index (EASI). The secondary objectives include:

• Comparison of efficacy using EASI and vIGA-AD at week 16.
• Assessment of pruritus through participant daily scoring at weeks 16 and 24.
• Evaluation of efficacy via EASI and vIGA-AD with additional measurement at week 24.
• Comparison of treatment effects on facial eczema, hand eczema, and genital eczema at week 24.
• Assessment of the Dermatology Life Quality Index (DLQI) at week 24 to evaluate patient-reported outcomes.

This clinical trial involves a total of 474 patients diagnosed with atopic dermatitis. The study population includes both male and female participants within the age ranges corresponding to codes 3 and 4. Eligible subjects must have a diagnosis confirmed by the AAD Consensus Criteria for a minimum duration of 12 months and a history of inadequate response to specific prior treatments. Inclusion is further defined by an Eczema Area and Severity Index score of at least 16, a vIGA-AD score of 3 or higher, and a pruritus numerical rating scale of at least 4.

This Phase 3, randomized, double-blind, placebo-controlled study evaluates the efficacy, safety, and tolerability of rocatinlimab monotherapy in adults diagnosed with moderate-to-severe atopic dermatitis. The clinical trial utilizes a subcutaneous injection of either rocatinlimab or a placebo. The study duration for participants is 24 weeks. The research methodology involves a screening period to confirm eligibility based on specific clinical criteria, including a minimum EASI score, vIGA-AD score, and pruritus levels. Primary endpoints include the assessment of skin clearance and eczema improvement at week 24. Secondary objectives focus on skin itching, pain, and quality of life as measured by the DLQI. The sequence of study visits includes the initial screening, periodic assessments throughout the 24-week period, and an end-of-study visit.

The experimental medication is rocatinlimab, provided as a solution for injection. The study involves the administration of 9999 mg via subcutaneous injection.

The control group receives a placebo intended for use in place of AMG 451.

This Phase 3, randomized, double-blind study evaluates the efficacy and safety of rocatinlimab monotherapy in adult subjects diagnosed with atopic dermatitis over a 24-week period.

The efficacy of rocatinlimab in adult subjects with moderate-to-severe atopic dermatitis is assessed through several primary and secondary endpoints. The primary efficacy assessment at week 24 is based on the proportion of subjects achieving clear or almost clear skin as determined by the validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD). Additionally, the primary assessment includes the proportion of subjects achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI) from baseline at week 24.

Secondary endpoints include the following evaluations:

• The proportion of subjects achieving clear or almost clear skin at week 16 using the vIGA-AD.
• Eczema improvement at week 24 based on EASI scores.
• Reduction in pruritus, assessed via participant daily scoring at week 16 and week 24.
• Reduction in skin pain, assessed via participant weekly scoring at week 24.
• Achievement of almost clear skin or clear skin with at most slight redness at week 24.
• Assessment of overall clear skin on the face and hands at week 24.
• Changes in quality of life at week 24 compared to baseline, as measured by the Dermatology Life Quality Index (DLQI).