A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Study Overview
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Brief Summary
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The co-primary objectives of the study are to: Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Official Title
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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)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Rocatinlimab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months History of inadequate response to TCS (Topical Corticosteroid) of medium or 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). EASI score ≥16 vIGA-AD score ≥3 ≥10% body surface area (BSA) of AD involvement Worst pruritus numerical rating scale ≥ 4 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 Oral or topical Janus kinase inhibitors Treatment with any of the following medications or therapies within 1 week, prior to Day 1: TCS of any potency TCI Topical phosphodiesterase type 4 inhibitors Other topical immunosuppressive agents Phototherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocatinlimab<br>Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. | Drug: Rocatinlimab<br>* Rocatinlimab will be administered through a subcutaneous (SC) injection.<br>* Other names: KHK 4083;|
| Placebo Comparator: Placebo<br>Placebo Q4W for 24 weeks with a loading dose at Week 2. | Other: Placebo<br>* The matching placebo will be administered through a SC injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a >= 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24 |  | Baseline and Week 24 | 
| Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 |  | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of EASI 75 at Week 16 |  | Baseline and Week 16 | 
| Achievement of vIGA-AD 0/1 at Week 16 |  | Baseline and Week 16 | 
| Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4 |  | Baseline and Week 16 | 
| Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4 |  | Baseline and Week 24 | 
| Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 |  | Baseline and Week 24 | 
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 |  | Baseline and Week 24 | 
| Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 |  | Baseline to Week 24 | 
| Achievement of vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response at Week 24 |  | Baseline and Week 24 | 
| Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline |  | Baseline and Week 24 | 
| Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline |  | Baseline and Week 24 | 
| Achievement of a Genital AD Severity Score of Clear at Week 24 for Participants with Genital AD at Baseline |  | Baseline and Week 24 | 
| Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 |  | Baseline and Week 24 | 
| Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in SCORAD Itch VAS Score at Week 24 |  | Baseline and Week 24 | 
| Achievement of a ≥ 4-point Reduction From Baseline in DLQI Score at Week 24 in Participants with Baseline DLQI ≥ 4 |  | Baseline and Week 24 | 
| Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score ≥ 4 |  | Baseline and Week 24 | 
| Change from Baseline in POEM Score at Week 24 |  | Baseline and Week 24 | 
| Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 |  | Baseline to Week 16 | 
| Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 |  | Baseline to Week 24 | 
| Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score >/=8 |  | Baseline and Week 24 | 
| Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score >/=8 |  | Baseline and Week 24 | 
| Change From Baseline in HADS-anxiety Subscale Score at Week 24 |  | Baseline and Week 24 | 
| Change From Baseline in HADS-depression Subscale Score at Week 24 |  | Baseline and Week 24 | 
| Achievement of a ≥ 8.7-point Reduction From Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7 |  | Baseline and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, AMG 451, KHK 4083, Eczema, Rocatinlimab