NCT05724199

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The coprimary objectives of the study are to: * evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). * evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2023-02-21
• Primary completion: 2024-09-15
• Completion: 2024-12-04
• First posted: 2023-02-13
• Last updated: 2025-11-24

Locations

234 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, France, Germany, Greece, Hungary, Italy, Japan, Malaysia, Netherlands, Poland, Puerto Rico, Romania, Singapore, Slovakia, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study