BENITIONSClinical Trial Intelligence

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

Phase 3 Completed NCT05651711

ConditionAtopic Dermatitis
PhasePhase 3
SponsorAmgen
StatusCompleted
Enrollment726 participants
InterventionsRocatinlimab
Start dateDec 14, 2022
Completion dateJun 5, 2024
Results postedJun 26, 2026

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).

Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (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 · Participants

Placebo9 Participants
Rocatinlimab 300 mg Q4W89 Participants
p-value< 0.001
Common risk difference percentage11.5 (95% CI 6.7–15.5)

Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24

Baseline and Week 24 · Participants

Placebo25 Participants
Rocatinlimab 300 mg Q4W178 Participants
p-value< 0.001
Common risk difference percentage19.1 (95% CI 12.4–25.2)

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