A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

Amgen532 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

532

Conditions

Atopic Dermatitis

Interventions

RocatinlimabDRUG

Subcutaneous (SC) injection

PlaceboDRUG

SC injection

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 12 to \< 18 years at Day 1. * Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield et al, 2014\]) that has been present for at least 12 months before signing of informed consent. * Body weight ≥ 40 kg at screening. * History of inadequate response to TCS of medium to higher potency (with or without TCI). * EASI score ≥ 12 at initial screening. * EASI score ≥ 16 at Day 1. * vIGA-AD score ≥ 3. * ≥10% body surface area of AD involvement. * Worst pruritus NRS ≥ 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: 1. Systemic corticosteroids 2. Non-biologic, non-targeted systemic immunosuppressants 3. Phototherapy 4. Oral or Topical Janus kinase inhibitors * Treatment with any of the following medications or therapies within 1 week, prior to Day 1: 1. TCS of any potency 2. TCI 3. Topical phosphodiesterase 4 inhibitors 4. Other topical immunosuppressive agents

Locations (246)

Outcomes

Primary Outcomes

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

Time frame: Baseline and Week 24

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

Time frame: Baseline and Week 24

Secondary Outcomes

Achievement of EASI 75 at Week 16

Time frame: Baseline and Week 16

Achievement of a vIGA-AD 0/1 at Week 16

Time frame: 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

Time frame: 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

Time frame: Baseline and Week 24

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

Time frame: Baseline and 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 and Week 24

Achievement of a vIGA-AD Score of 1 with Presence of Only Barely Perceptible Erythema or vIGA-AD Score of 0 (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, United States

AllerVie Clinical Research- Cullman

Cullman, Alabama, United States

Eclipse Clinical Research

Tucson, Arizona, United States

Arkansas Research Trials, LLC

North Little Rock, Arkansas, United States

Center for Dermatology Clinical Research Inc

Fremont, California, United States

Doc1 Healthcare Systems Incorporated

Fullerton, California, United States

Axon Clinical Research

Inglewood, California, United States

Avance Clinical Trials

Laguna Niguel, California, United States

Cura Clinical Research

Palmdale, California, United States

Integrative Skin Science and Research

Sacramento, California, United States

...and 236 more locations

Time frame: Baseline and Week 24

Initiation of rescue therapy for AD at or before Week 16

Time frame: Baseline to Week 16

Initiation of rescue therapy for AD at or before Week 24

Time frame: Baseline to Week 24

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

Time frame: Baseline to Week 16

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

Time frame: Baseline to Week 24

Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16

Time frame: Baseline to Week 16

Change From Baseline in SCORAD Itch VAS Score at Week 24

Time frame: Baseline to 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 in Participants ≥ 16 Years of Age at Enrollment

Time frame: Baseline and Week 24

Change From Baseline in DLQI Score at Week 24 in Participants ≥ 16 Years of Age at Enrollment

Time frame: Baseline to Week 24

Change From Baseline in CDLQI Score at Week 24 in Participants < 16 Years of Age at Enrollment

Time frame: Baseline to 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 and Week 24

Change From Baseline in POEM Score at Week 24

Time frame: Baseline to Week 24

Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 4

Time frame: Baseline and Week 16

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

Time frame: Baseline and Week 24

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

Time frame: Baseline and Week 16

Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3

Time frame: Baseline and Week 24

Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3

Time frame: Baseline and Week 16

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

Time frame: Baseline to 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 and Week 24

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

Time frame: Baseline to 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 and Week 24

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

Time frame: Baseline to Week 24

Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7

Time frame: Baseline and Week 24