Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
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Amgen Inc. is conducting a Phase 3 study titled ‘A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)'. The study aims to evaluate the safety and tolerability of rocatinlimab in adolescents suffering from moderate-to-severe atopic dermatitis, a condition that significantly impacts quality of life.
The intervention being tested is Rocatinlimab, an experimental drug administered via subcutaneous injection every four weeks, with an additional dose at Week 2. This treatment is designed to alleviate the symptoms of atopic dermatitis in the targeted age group.
The study employs an interventional design with a single-group model, meaning all participants receive the same treatment. There is no masking involved, and the primary purpose is treatment-focused, ensuring a straightforward approach to evaluating the drug’s effects.
The study began on January 30, 2023, and is currently active but not recruiting. The last update was submitted on July 1, 2025. These dates are crucial as they provide a timeline for potential results and subsequent market actions.
The outcome of this study could significantly influence Amgen’s stock performance, as positive results may enhance investor confidence and market position in the dermatology sector. Competitors in the atopic dermatitis treatment market will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.