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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 221
- Locations
- 170
- Primary Endpoint
- Number of Participants with a Positive Anti-tetanus Response
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 54 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rocatinlimab
Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Intervention: Rocatinlimab (Drug)
Placebo
Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants with a Positive Anti-tetanus Response
Time Frame: Week 20 to week 24
Number of Participants with a Positive Anti-meningococcal Response
Time Frame: Week 20 to week 24
Percentage of Participants With a Positive Anti-tetanus Response at Week 24
Time Frame: Week 20 to Week 24
Participants received 1 dose of a tetanus vaccine at Week 20. The antibody response to the tetanus vaccine was assessed by measuring serum anti-tetanus immunoglobulin G (IgG) by an immunoassay.
Percentage of Participants With a Positive Anti-meningococcal Response at Week 24
Time Frame: Week 20 to Week 24
Participants received 1 dose of a meningococcal vaccine at Week 20. The antibody response to the meningococcal vaccine was assessed by measuring serum anti-meningococcal IgG by an immunoassay.
Secondary Outcomes
No secondary outcomes reported