NCT05882877

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

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,621 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2023-05-31
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2023-05-31
• Last updated: 2025-11-03

Locations

547 sites across 42 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study