A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
Phase 3
Completed
NCT05398445
| Condition | Atopic Dermatitis |
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| Phase | Phase 3 |
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| Sponsor | Amgen |
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| Status | Completed |
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| Enrollment | 769 participants |
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| Interventions | Rocatinlimab |
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| Start date | May 31, 2022 |
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| Completion date | Nov 28, 2024 |
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| Results posted | Jul 23, 2026 |
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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
| Placebo | 18 Participants |
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| Rocatinlimab 150 mg Q4W | 35 Participants |
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| Rocatinlimab 300 mg Q4W | 74 Participants |
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| p-value | = 0.010 |
| Common risk difference percentage | 8.0 (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
| Placebo | 28 Participants |
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| Rocatinlimab 150 mg Q4W | 78 Participants |
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| Rocatinlimab 300 mg Q4W | 138 Participants |
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| p-value | < 0.001 |
| Common risk difference percentage | 23.4 (95% CI 15.4–30.9) |
Open in BENITIONS
View on ClinicalTrials.gov
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