A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Study Details
The co-primary objectives of the study are to:
- Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD).
- Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
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 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 ≥ 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 to Week 24
Achievement of 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
Timeframe: Baseline and Week 24
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Timeframe: Baseline and Week 24
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Timeframe: Baseline and Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Timeframe: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Timeframe: Baseline and Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
Timeframe: Baseline and 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
Timeframe: Baseline and Week 24
Change From Baseline in DLQI Score at Week 24
Timeframe: Baseline and 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 and Week 24
Achievement of ≥ 4-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Timeframe: Baseline to Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Timeframe: Baseline to 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 ≥ 3-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 ≥ 3
Timeframe: Baseline to Week 24
Achievement of ≥ 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3
Timeframe: Baseline to Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Timeframe: Baseline to Week 24
Achievement of 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
Achievement of 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-anxiety Subscale Score at Week 24
Timeframe: Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Timeframe: Baseline and Week 24
Achievement of a ≥ 8.7-point Reduction From Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7
Timeframe: Baseline and Week 24