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A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501586-50-00
Acronym
20210145
Enrollment
155
Registered
2023-04-19
Start date
2023-05-15
Completion date
2025-07-28
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

Achieving a pre-determined score at week 24, Achieving a pre-determined score at week 24

Detailed description

Achieving a pre-determined score, Achieving a pre-determiend score, Achieving a pre-determined score from baseline in weekly average of daily worst pruritus numeric rating scale (NRS) score in subjects with baseline weekly average of daily worst pruritus NRS score Achieving a pre-determined score from baseline in weekly average of daily worst pruritus NRS score at week 24 in subjects with baseline weekly average of daily worst pruritus NRS score, Achieving a pre-determined reduction from baseline in EASI at week 24, Achieving a pre-determined score from baseline in weekly average of AD skin pain NRS score at week 24 in subjects with baseline weekly average of AD skin pain NRS, Achieving a pre-determined score with presence of only barely perceptible erythema at week 24

Interventions

None listed

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Achieving a pre-determined score at week 24, Achieving a pre-determined score at week 24

Secondary

MeasureTime frame
Achieving a pre-determined score, Achieving a pre-determiend score, Achieving a pre-determined score from baseline in weekly average of daily worst pruritus numeric rating scale (NRS) score in subjects with baseline weekly average of daily worst pruritus NRS score Achieving a pre-determined score from baseline in weekly average of daily worst pruritus NRS score at week 24 in subjects with baseline weekly average of daily worst pruritus NRS score, Achieving a pre-determined reduction from baseline in EASI at week 24, Achieving a pre-determined score from baseline in weekly average of AD skin pain NRS score at week 24 in subjects with baseline weekly average of AD skin pain NRS, Achieving a pre-determined score with presence of only barely perceptible erythema at week 24

Countries

Belgium, Croatia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026