A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

Study Overview
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Brief Summary
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The coprimary objectives of the study are to: evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI 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) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

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 with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months History of inadequate response to TCS of medium or higher potency (with or without TCI) 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 Phototherapy Janus kinase inhibitors Treatment with any of the following medications or therapies within 1 week, prior to Day 1: TCS TCI Topical phosphodiesterase type 4 inhibitors Other topical immunosuppressive agents Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocatinlimab Dose 1 + TCS/TCI<br>Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2. | Drug: Rocatinlimab<br>* Subcutaneous (SC) injection<br>* Other names: AMG 451;|
| Experimental: Rocatinlimab Dose 2 + TCS/TCI<br>Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. | Drug: Rocatinlimab<br>* Subcutaneous (SC) injection<br>* Other names: AMG 451;|
| Placebo Comparator: Placebo + TCS/TCI<br>Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. | Other: Placebo<br>* SC injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24 |  | Baseline, Week 24 | 
| Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of EASI 75 at Week 16 |  | Baseline, Week 16 | 
| Achievement of vIGA-AD 0/1 at Week 16 |  | Baseline, 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, 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, Week 24 | 
| Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 |  | Baseline, Week 24 | 
| Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 |  | Baseline, Week 24 | 
| Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 |  | Baseline, Week 24 | 
| Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response at Week 24 |  | Baseline, Week 24 | 
| Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline |  | Baseline, Week 24 | 
| Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline |  | Baseline, Week 24 | 
| Achievement of a Genital AD Severity Score of Clear at Week 24 for Participants with Genital AD at Baseline |  | Baseline, Week 24 | 
| Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 |  | Baseline, Week 16 | 
| Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 |  | Baseline, Week 24 | 
| Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 |  | Baseline, Week 16 | 
| Change From Baseline in SCORAD Itch VAS Score at Week 24 |  | Baseline, Week 24 | 
| Achievement of ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score ≥ 4 |  | Baseline, 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, Week 24 | 
| Change From Baseline in POEM Score at Week 24 |  | Baseline, Week 24 | 
| Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 |  | Baseline, Week 16 | 
| Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 |  | Baseline, Week 24 | 
| Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8 |  | Baseline, Week 24 | 
| Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8 |  | Baseline, Week 24 | 
| Change From Baseline in HADS-anxiety Subscale Score at Week 24 |  | Baseline, Week 24 | 
| Change From Baseline in HADS-depression Subscale Score at Week 24 |  | Baseline, 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, 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, Eczema, Rocatinlimab, KHK4083