A Study Assessing Rocatinlimab in Combination with Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants with Moderate-to-severe Atopic Dermatitis (AD)ROCKET-SHUTTLE
Study Details
The coprimary objectives of the study are to:
- evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD™).
- evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
Protocol Summary
Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24
Timeframe: Baseline, Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Timeframe: Baseline, Week 24
Achievement of EASI 75 at Week 16
Timeframe: Baseline, Week 16
Achievement of vIGA-AD 0/1 at Week 16
Timeframe: Baseline, 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, 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, Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Timeframe: Baseline, 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, Week 24
Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response (Revised IGA [rIGA™] 0/1) at Week 24
Timeframe: Baseline, Week 24
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Timeframe: Baseline, Week 24
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Timeframe: Baseline, Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Timeframe: Baseline, Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Timeframe: Baseline, Week 24
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Timeframe: Baseline, Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
Timeframe: Baseline, Week 24
Achievement of ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score ≥ 4
Timeframe: Baseline, Week 24
Change from Baseline in DLQI Score at Week 24
Timeframe: Baseline, 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, Week 24
Change From Baseline in POEM Score at Week 24
Timeframe: Baseline, Week 24
Achievement of a ≥ 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, Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Timeframe: Baseline, Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Timeframe: Baseline, Week 16
Achievement of a ≥ 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, Week 24
Achievement of a ≥ 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, Week 16
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24
Timeframe: Baseline, 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, Week 24
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
Timeframe: Baseline, Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Timeframe: Baseline, Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Timeframe: Baseline, 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, Week 24