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A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
About
Brief Summary
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
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
23-5180
Category
Healthy Volunteers
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood