A Phase 3, 24-week, Randomized, 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-Ignite)

Conditions

Atopic Dermatitis

Brief summary

Achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) with ≥ 2-point reduction from baseline (vIGA-AD 0/1) at week 24, Achieving ≥ 75% reduction from baseline in EASI score (EASI 75) at week 24

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, Acheiving 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 score., Achieving Clear skin at week 24 for subjects with hand AD at baseline, Acheiving 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 score., Achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [rIGA] 0/1) at week 24

Related papers

No related papers found yet.

Interventions

DRUGPlacebo for AMG 451 will be presented in identical containers

DRUGand stored/packaged the same as rocatinlimab

DRUGRocatinlimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) with ≥ 2-point reduction from baseline (vIGA-AD 0/1) at week 24, Achieving ≥ 75% reduction from baseline in EASI score (EASI 75) at week 24	—

Secondary

Measure	Time 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, Acheiving 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 score., Achieving Clear skin at week 24 for subjects with hand AD at baseline, Acheiving 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 score., Achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [	—

Measure

Time 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, Acheiving 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 score., Achieving Clear skin at week 24 for subjects with hand AD at baseline, Acheiving 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 score., Achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [

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Countries

Croatia, Czechia, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Slovakia, Spain

Outcome results

None listed