A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

Phase 3CompletedNCT05398445

Amgen769 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

769

Conditions

Atopic Dermatitis

Interventions

RocatinlimabDRUG

Participants will receive Rocatinlimab subcutaneously.

PlaceboDRUG

Participants will receive a placebo subcutaneously.

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 Consensus Criteria (2014) present for at least 12 months * History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]). * 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 * Systemic immunosuppressants * Phototherapy * Janus kinase inhibitors * Treatment with any of the following medications or therapies within 1 week, prior to Day 1: * TCS of any potency * TCI * Topical phosphodiesterase type 4 inhibitors * Other topical immunosuppressive agents * Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Locations (202)

Outcomes

Primary Outcomes

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

Time frame: Baseline, Week 24

Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24

Time frame: Baseline, Week 24

Secondary Outcomes

Achievement of ≥75% reduction from baseline in EASI score at Week 16

Time frame: Baseline, Week 16

Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16

Time frame: 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

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 subjects 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 at Week 24

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center

Phoenix, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

First OC Dermatology

Fountain Valley, California, United States

Kaiser Permanente - Glendale Medical Center

Glendale, California, United States

Long Beach Research Institute

Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Cura Clinical Research

Sherman Oaks, California, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

...and 192 more locations

Time frame: Baseline, Week 24

Achievement of Facial AD Severity Score (FASS) of clear at Week 24 for subjects with facial AD at baseline

Time frame: Baseline, Week 24

Achievement of Hand AD Severity Score (HASS) of clear at Week 24 for subjects 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 DLQI score at Week 24 in subjects 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 ≥ 4-point reduction from baseline in POEM score at Week 24 in subjects 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 daily AD skin pain NRS score at Week 16 in subjects 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 daily AD skin pain NRS score at Week 24 in subjects 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 daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3

Time frame: Baseline, Week 16

Change from baseline in weekly average of daily sleep disturbance NRS score at Week 24

Time frame: 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

Time frame: Baseline, Week 24

Change from baseline in HADS-anxiety subscale score at Week 24

Time frame: Baseline, Week 24

Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8

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