A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
- Registration Number
- NCT05724199
- Lead Sponsor
- Amgen
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 746
- Age ≥ 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
- History of inadequate response to TCS of medium or higher potency (with or without TCI)
- EASI score ≥16
- vIGA-AD score ≥3
- ≥10% body surface area (BSA) of AD involvement
- Worst pruritus numerical rating scale ≥ 4
-
Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
-
Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
- Systemic corticosteroids
- Nonbiologic, non-targeted Systemic immunosuppressants
- Phototherapy
- Janus kinase inhibitors
-
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS
- TCI
- Topical phosphodiesterase type 4 inhibitors
- Other topical immunosuppressive agents
- Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Rocatinlimab Dose 2 + TCS/TCI Rocatinlimab Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. Placebo + TCS/TCI Placebo Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. Rocatinlimab Dose 1 + TCS/TCI Rocatinlimab Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.
- Primary Outcome Measures
Name Time Method Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24 Baseline, Week 24 Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 Baseline, Week 24
- Secondary Outcome Measures
Name Time Method Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 Baseline, Week 24 Achievement of EASI 75 at Week 16 Baseline, Week 16 Achievement of vIGA-AD 0/1 at Week 16 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 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 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 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 Baseline, Week 24 Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline Baseline, Week 24 Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline Baseline, Week 24 Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 Baseline, Week 16 Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 Baseline, Week 24 Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 Baseline, Week 16 Change From Baseline in SCORAD Itch VAS Score at Week 24 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 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 Baseline, Week 24 Change from Baseline in DLQI Score at Week 24 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 Baseline, Week 16 Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 Baseline, Week 24 Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 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 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 Baseline, Week 16 Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 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 Baseline, Week 24 Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8 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 Baseline, Week 24 Change From Baseline in HADS-anxiety Subscale Score at Week 24 Baseline, Week 24 Change From Baseline in HADS-depression Subscale Score at Week 24 Baseline, Week 24 Change From Baseline in POEM Score at Week 24 Baseline, Week 24
Trial Locations
- Locations (233)
Salford Care Organisation
🇬🇧Salford, United Kingdom
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
Southwest Skin Specialists
🇺🇸Phoenix, Arizona, United States
US Dermatology Partners Sun City West
🇺🇸Sun City West, Arizona, United States
Arkansas Research Trials, LLC
🇺🇸North Little Rock, Arkansas, United States
Kern Research Inc
🇺🇸Bakersfield, California, United States
Keck Medicine of University of Southern California
🇺🇸Los Angeles, California, United States
Wallace Medical Group Inc
🇺🇸Los Angeles, California, United States
Antelope Valley Clinical Trials
🇺🇸Palmdale, California, United States
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