Skip to content

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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501585-22-00
Acronym
20210144
Enrollment
307
Registered
2023-04-20
Start date
2023-05-11
Completion date
2025-06-16
Last updated
2025-06-16

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

Detailed description

Achieving EASI 75 at week 16, Achieving vIGA-AD 0/1 at week 16, Achieving from baseline in weekly average of daily worst pruritus numeric rating scale (NRS) score at week 16 in subjects with baseline weekly average of daily worst pruritus NRS score, Achieving 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 ≥ 90% reduction from baseline in EASI score (EASI 90) at week 24, Change from baseline in weekly average of daily AD skin pain NRS score at week 24, Achieving vIGA-AD response with presence of only barely perceptible erythema or vIGA-AD 0 response at week 24, Achieving a Facial AD Severity Score of clear at week 24 for subjects with facial AD at baseline, Achieving a Hand AD Severity Score of clear at week 24 for subjects with hand AD at baseline

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

Secondary

MeasureTime frame
Achieving EASI 75 at week 16, Achieving vIGA-AD 0/1 at week 16, Achieving from baseline in weekly average of daily worst pruritus numeric rating scale (NRS) score at week 16 in subjects with baseline weekly average of daily worst pruritus NRS score, Achieving 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 ≥ 90% reduction from baseline in EASI score (EASI 90) at week 24, Change from baseline in weekly average of daily AD skin pain NRS score at week 24, Achieving vIGA-AD response with presence of only barely perceptible erythema or vIGA-AD 0 response at week 24, Achieving a Facial AD Severity Score of clear at week 24 for subjects with facial AD at baseline, Achieving a Hand AD Severity Score of clear at week 24 for subjects with hand AD at baseline

Countries

Austria, Belgium, Bulgaria, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain

Outcome results

None listed

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