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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501587-17-00

Acronym

20210146

Enrollment

615

Registered

2023-09-25

Start date

2023-10-20

Completion date

Unknown

Last updated

2026-01-16

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

Conditions

Atopic Dermatitis

Brief summary

Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs) and serious adverse events

Detailed description

Maintaining vIGA-AD™ 0/1 response among subjects achieving vIGA-AD 0/1 response at day 1, Maintaining revised IGA (rIGA™) 0/1 response among subjects achieving rIGA 0/1 response at day one, Maintaining EASI 75 response among subjects achieving EASI 75 response at day 1, Maintaining vIGA-AD 0/1 response and EASI 75 response among subjects achieving vIGA-AD 0/1 response and EASI 75 response at day 1, Maintaining reduction from parent study baseline in worst pruritus NRS score among subjects achieving reduction from parent study baseline in worst pruritus NRS score at day 1

Interventions

DRUGPlacebo for amg 451

DRUGRocatinlimab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs) and serious adverse events	—

Secondary

Measure	Time frame
Maintaining vIGA-AD™ 0/1 response among subjects achieving vIGA-AD 0/1 response at day 1, Maintaining revised IGA (rIGA™) 0/1 response among subjects achieving rIGA 0/1 response at day one, Maintaining EASI 75 response among subjects achieving EASI 75 response at day 1, Maintaining vIGA-AD 0/1 response and EASI 75 response among subjects achieving vIGA-AD 0/1 response and EASI 75 response at day 1, Maintaining reduction from parent study baseline in worst pruritus NRS score among subjects achieving reduction from parent study baseline in worst pruritus NRS score at day 1	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

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