A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

Amgen746 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

746

Conditions

Atopic Dermatitis

Interventions

Rocatinlimab

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (234)

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

Outcomes

Primary Outcomes

Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24

Time frame: Baseline, Week 24

Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24

Time frame: Baseline, Week 24

Secondary Outcomes

Achievement of EASI 75 at Week 16

Time frame: Baseline, Week 16

Achievement of vIGA-AD 0/1 at Week 16

Time frame: 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

Time frame: 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

Time frame: Baseline, Week 24

Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24

Time frame: 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

Time frame: 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

Time frame: Baseline, Week 24

Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline

Time frame: Baseline, Week 24

Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline

Time frame: Baseline, Week 24

Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16

Time frame: Baseline, Week 16

Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24

Time frame: Baseline, Week 24

Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16

Time frame: Baseline, Week 16

Change From Baseline in SCORAD Itch VAS Score at Week 24

Time frame: 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

Time frame: Baseline, Week 24

Change from Baseline in DLQI Score at Week 24

Time frame: 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

Time frame: Baseline, Week 24

Change From Baseline in POEM Score at Week 24

Time frame: 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

Time frame: Baseline, Week 16

Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24

Time frame: Baseline, Week 24

Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16

Time frame: 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

Time frame: 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

Time frame: Baseline, Week 16

Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24

Time frame: 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

Time frame: Baseline, Week 24

Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8

Time frame: Baseline, Week 24

Change From Baseline in HADS-anxiety Subscale Score at Week 24

Time frame: Baseline, Week 24

Change From Baseline in HADS-depression Subscale Score at Week 24

Time frame: 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

Time frame: Baseline, Week 24