Study Complete
Sponsor ID
20210142
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
Study Details
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
Protocol Summary
Primary Outcome Measures
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24
Timeframe: Baseline, Week 24
Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24
Timeframe: Baseline, Week 24
Secondary Outcome Measures
Achievement of ≥75% reduction from baseline in EASI score at Week 16
Timeframe: Baseline, Week 16
Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16
Timeframe: Baseline, Week 16
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at Week 16 in subjects 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 subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4
Timeframe: Baseline, Week 24
Achievement of ≥90% reduction from baseline in EASI score at Week 24
Timeframe: Baseline, Week 24
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4
Timeframe: Baseline, Week 24
Achievement of a 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, Week 24
Achievement of Facial AD Severity Score (FASS) of clear at Week 24 for subjects with facial AD at baseline
Timeframe: Baseline, Week 24
Achievement of Hand AD Severity Score (HASS) of clear at Week 24 for subjects 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 DLQI score at Week 24 in subjects with baseline DLQI score ≥ 4
Timeframe: Baseline, Week 24
Change from baseline in DLQI score at Week 24
Timeframe: Baseline, Week 24
Achievement of ≥ 4-point reduction from baseline in POEM score at Week 24 in subjects 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 daily AD skin pain NRS score at Week 16 in subjects 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 daily AD skin pain NRS score at Week 24 in subjects 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 daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3
Timeframe: Baseline, Week 16
Change from baseline in weekly average of daily sleep disturbance NRS score at Week 24
Timeframe: Baseline, Week 24
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at Week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8
Timeframe: Baseline, Week 24
Change from baseline in HADS‑anxiety subscale score at Week 24
Timeframe: Baseline, Week 24
Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8
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
Locations
Location
Dermatology Research Associates
Los Angeles, CA, United States, 90045
Status
Recruiting
Location
Alliance Dermatology and Mohs Center
Phoenix, AZ, United States, 85032
Status
Recruiting
Location
Dermatology Research Center of Oklahoma, PLLC
Tulsa, OK, United States, 74132
Status
Recruiting
Location
The Indiana Clinical Trials Center PC
Plainfield, IN, United States, 46168
Status
Recruiting
Location
ClinOhio Research Services
Columbus, OH, United States, 43213
Status
Recruiting
Location
Jubilee Clinical Research Inc
Las Vegas, NV, United States, 89106
Status
Recruiting
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