NCT05899816

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atopic Dermatitis
• Moderate-to-severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Rocatinlimab	Subcutaneous (SC) injection
DRUG	Placebo	SC injection

Timeline

• Start date: 2023-06-07
• Primary completion: 2024-08-26
• Completion: 2024-11-14
• First posted: 2023-06-12
• Last updated: 2025-11-05

Locations

85 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study