BENITIONSClinical Trial Intelligence

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

Phase 3 Completed NCT05398445

ConditionAtopic Dermatitis
PhasePhase 3
SponsorAmgen
StatusCompleted
Enrollment769 participants
InterventionsRocatinlimab
Start dateMay 31, 2022
Completion dateNov 28, 2024
Results postedJul 23, 2026

Summary

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

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

Placebo18 Participants
Rocatinlimab 150 mg Q4W35 Participants
Rocatinlimab 300 mg Q4W74 Participants
p-value= 0.010
Common risk difference percentage8.0 (95% CI 1.8–14.0)

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

Placebo28 Participants
Rocatinlimab 150 mg Q4W78 Participants
Rocatinlimab 300 mg Q4W138 Participants
p-value< 0.001
Common risk difference percentage23.4 (95% CI 15.4–30.9)

Open in BENITIONS View on ClinicalTrials.gov

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