A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ROCKET-ASTRO
Study Details
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
Protocol Summary
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Timeframe: Baseline and Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Timeframe: Baseline and Week 24
Achievement of EASI 75 at Week 16
Timeframe: Baseline and Week 16
Achievement of a vIGA-AD 0/1 at Week 16
Timeframe: Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Timeframe: Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Timeframe: Baseline and Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Timeframe: Baseline and Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Timeframe: Baseline and Week 24
Achievement of a vIGA-AD Score of 1 with Presence of Only Barely Perceptible Erythema or vIGA-AD Score of 0 (revised Investigator’s Global Assessment [rIGA™] 0/1) at Week 24
Timeframe: Baseline and Week 24
Initiation of rescue therapy for AD at or before Week 16
Timeframe: Baseline to Week 16
Initiation of rescue therapy for AD at or before Week 24
Timeframe: Baseline to Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Timeframe: Baseline to Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Timeframe: Baseline to Week 24
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16
Timeframe: Baseline to Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
Timeframe: Baseline to Week 24
Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4 in Participants ≥ 16 Years of Age at Enrollment
Timeframe: Baseline and Week 24
Change From Baseline in DLQI Score at Week 24 in Participants ≥ 16 Years of Age at Enrollment
Timeframe: Baseline to Week 24
Change From Baseline in CDLQI Score at Week 24 in Participants < 16 Years of Age at Enrollment
Timeframe: Baseline to Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score ≥ 4
Timeframe: Baseline and Week 24
Change From Baseline in POEM Score at Week 24
Timeframe: Baseline to Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 4
Timeframe: Baseline and Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Timeframe: Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Timeframe: Baseline and Week 16
Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Timeframe: Baseline and Week 24
Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Timeframe: Baseline and Week 16
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24
Timeframe: Baseline to Week 24
Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8
Timeframe: Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Timeframe: Baseline to Week 24
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
Timeframe: Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Timeframe: Baseline to Week 24
Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7
Timeframe: Baseline and Week 24