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

• Status: Not yet recruiting
• Trial end date: 2024-12-22
• Target enrollment: 0
• Participant gender: All

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

• characterize the safety and tolerability of rocatinlimab in the proposed population

• evaluate the immunogenicity of rocatinlimab

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: KHK4083

Criteria

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 or higher potency (with or without topical calcineurin inhibitors)

• 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

• Topical calcineurin inhibitors (TCI)

• Anti-pruritic agents or antihistamines used for treatment of pruritis

• 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. Inactivated vaccination (eg, non-live or nonreplicating agent), including coronavirus disease 2019 (COVID-19) vaccination, is allowed.

• 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