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

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

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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