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

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Amgen

Status and phase

Active, not recruiting
Phase 3

Conditions

Atopic Dermatitis
Moderate-to-severe Atopic Dermatitis

Treatments

Drug: Placebo
Drug: Rocatinlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05899816
20210158

Details and patient eligibility

About

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

Enrollment

221 patients

Sex

All

Ages

18 to 54 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

221 participants in 2 patient groups, including a placebo group

Rocatinlimab
Experimental group
Description:
Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Treatment:
Drug: Rocatinlimab
Placebo
Placebo Comparator group
Description:
Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Treatment:
Drug: Placebo

Trial contacts and locations

86

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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