A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

Study Overview
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Brief Summary
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The primary objectives of this study are to: estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24

Official Title
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A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

Conditions
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Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis

Intervention / Treatment
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* Drug: Rocatinlimab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors) Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout. Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 Exclusion Criteria: Treatment with a biologic 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 of any potency Topical calcineurin inhibitors (TCI) Topical Phosphodiesterase-4 inhibitors (PDE4) Other topical immunosuppressive agents Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocatinlimab<br>Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. | Drug: Rocatinlimab<br>* Subcutaneous (SC) injection<br>* Other names: KHK4083;|
| Placebo Comparator: Placebo<br>Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. | Drug: Placebo<br>* SC injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with a Positive Anti-tetanus Response |  | Week 20 to week 24 | 
| Number of Participants with a Positive Anti-meningococcal Response |  | Week 20 to week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab