A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

Study Overview
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Brief Summary
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The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Official Title
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A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Rocatinlimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 12 to < 18 years at day 1. Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) Eczema Area and Severity Index (EASI) score ≥ 12 vIGA-AD score ≥ 3 ≥ 10% BSA of AD involvement at day 1 pre-enrollment Exclusion Criteria: Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: Systemic corticosteroids Systemic immunosuppressants Phototherapy Oral or topical janus kinase inhibitors Treatment with any of the following agents within 1 week before day 1 pre-enrollment: Topical PDE4 inhibitors Other topical immunosuppressive agents (not including TCS/TCI) Combination topical agents containing a high- or super-high potency corticosteroid

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocatinlimab<br>Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2. | Drug: Rocatinlimab<br>* Subcutaneous (SC) injection<br>* Other names: AMG 451;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Serious Adverse Events |  | Up to 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Rocatinlimab, AMG 451, KHK4083