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A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501538-44-00
Acronym
20210143
Enrollment
234
Registered
2023-03-28
Start date
2023-04-25
Completion date
2025-06-17
Last updated
2025-06-17

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

Conditions

Atopic Dermatitis

Brief summary

Whether or not a participant has a clear or almost clear skin at week 24 based on vIGA-AD., Whether or not a participant’s eczema is at least 75% better at week 24 compared to the start of the study based on EASI.

Detailed description

Whether or not a participant’s eczema has achieved certain improvement as compared to the start of the study based on EASI, Whether or not a participant has a clear or almost clear skin at week 16 based on vIGA-AD, Whether or not a participant has less skin itching at week 16 compared to the start of the study based on the participant’s daily scoring. Whether or not a participant has less skin itching at week 24 compared to the start of the study based on the participant’s daily scoring, Whether or not a participant’s eczema has achieved certain improvement at week 24 compared to the start of the study based on EASI, Whether or not a participant has less ezcema skin pain at week 24 compared to the start of the study based on participant's weekly scoring, Whether or not a participant has almost clear skin or almost clear skin with at most slight redness or clear skin at week 24, Whether or not a participant has an overall clear skin on the face at week 24., Whether or not a participant has an overall clear skin on the hand at week 24., A participant’s quality of life at week 24 compared to the start of the study while having eczema based on DLQI. DLQI measures how a participant feels about the quality of life because of skin diseases

Interventions

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Whether or not a participant has a clear or almost clear skin at week 24 based on vIGA-AD., Whether or not a participant’s eczema is at least 75% better at week 24 compared to the start of the study based on EASI.

Secondary

MeasureTime frame
Whether or not a participant’s eczema has achieved certain improvement as compared to the start of the study based on EASI, Whether or not a participant has a clear or almost clear skin at week 16 based on vIGA-AD, Whether or not a participant has less skin itching at week 16 compared to the start of the study based on the participant’s daily scoring. Whether or not a participant has less skin itching at week 24 compared to the start of the study based on the participant’s daily scoring, Whether or not a participant’s eczema has achieved certain improvement at week 24 compared to the start of the study based on EASI, Whether or not a participant has less ezcema skin pain at week 24 compared to the start of the study based on participant's weekly scoring, Whether or not a participant has almost clear skin or almost clear skin with at most slight redness or clear skin at week 24, Whether or not a participant has an overall clear skin on the face at week 24., Whether or not a participan

Countries

Belgium, Czechia, Denmark, Estonia, Finland, Germany, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

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