A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Other: Placebo
Drug: Rocatinlimab

Registration Number: NCT05651711

Lead Sponsor: Amgen

Brief Summary: The co-primary objectives of the study are to:

* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).

* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 726

Inclusion Criteria

Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
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
- Oral or topical 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 (PDE4) inhibitors
- Other topical immunosuppressive agents
- Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Q4W for 24 weeks with a loading dose at Week 2.
Rocatinlimab	Rocatinlimab	Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 and Week 24
Achievement of 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	Baseline and Week 24
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline	Baseline and Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16	Baseline and Week 16
Achievement of vIGA-AD 0/1 at Week 16	Baseline and Week 16
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 and Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24	Baseline and Week 24
Achievement of ≥ 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 to Week 24
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline	Baseline and 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	Baseline and Week 24
Change from Baseline in POEM Score at Week 24	Baseline and Week 24
Change from Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16	Baseline and Week 16
Achievement of ≥ 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 to Week 24
Achievement of ≥ 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 to Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24	Baseline to Week 24
Achievement of EASI 75 at Week 16	Baseline and Week 16
Change From Baseline in DLQI Score at Week 24	Baseline and Week 24
Achievement of ≥ 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 to Week 16
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8	Baseline and 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 and Week 24
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 and Week 16
Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8	Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24	Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24	Baseline to Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24	Baseline and Week 24
Change From Baseline in SCORAD Itch VAS Score at Week 24	Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24	Baseline and Week 24
Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16	Baseline and Week 16

Trial Locations

Locations (197): Research Solutions of Arizona, PC
🇺🇸
Litchfield Park, Arizona, United States
Center for Dermatology and Plastic Surgery
🇺🇸
Scottsdale, Arizona, United States
Clinical Trials Institute of Northwest Arkansas
🇺🇸
Fayetteville, Arkansas, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Velocity Clinical Research Chula Vista
🇺🇸
Chula Vista, California, United States
West Coast Research LLC
🇺🇸
Dublin, California, United States
California Dermatology and Clinical Research Institute
🇺🇸
Encinitas, California, United States
Center for Dermatology Clinical Research Inc
🇺🇸
Fremont, California, United States
Velocity Clinical Research - San Diego
🇺🇸
La Mesa, California, United States
Velocity Clinical Research - North Hollywood
🇺🇸
North Hollywood, California, United States
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Research Solutions of Arizona, PC
🇺🇸Litchfield Park, Arizona, United States