NCT05633355

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Rocatinlimab	Subcutaneous (SC) injection

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2022-12-01
• Last updated: 2025-12-11

Locations

77 sites across 9 countries: United States, Argentina, Australia, Brazil, Canada, Hong Kong, South Korea, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study