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Overall Recruitment Status: Active, currently enrolling |
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Official Title |
A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND) |
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Region |
Sponsors |
California - Northern |
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Acronym |
NCT No. |
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NCT05882877 |
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Study Type |
Phase |
Clinical Trial |
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Purpose |
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD. |
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Detailed Description |
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- • Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
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- • Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.
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- Atopic Dermatitis, Rocatinlimab, AMG 451, Eczema,
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