Double-blind Phase III maintenance study to assess Rocatinlimab in moderate to severe AD (ROCKET-ASCEND)

Zusammenfassung der Studie

Participants receive every 4 weeks (last dose at week 20), with 1 additional dose at week 2, either Rocatinlimab 300 mg, Rocatinlimab 150 mg, or placebo as an injection. From the first dose of either Rocatinlimab or placebo, participants apply topical TCS and/or TCI daily until they receive further instructions from the investigator. After the first dose of Rocatinlimab, participants are observed for 2 hours on Day 1, and for 30 minutes after all other doses. Participants use a moisturizer cream twice daily. After the first 6 weeks of the study, medications that are typically used by physicians to treat AD and approved by the health authority for AD may be administered if a participant has symptoms that do not improve or worsen, and if the physician believes that additional medication (rescue) is necessary.

(BASEC)

Untersuchte Intervention

This is a Phase III study, the final stage in the development process for human medicines. Researchers want to assess whether Rocatinlimab in combination with a TCS/TCI is effective and well-tolerated compared to a placebo in combination with TCS/TCI for the treatment of AD and whether the drug causes side effects. Until the end of the study, neither participants nor doctors will know which investigational product each participant has received. This is to ensure that the study results are not influenced in any way. The study may last up to 40 weeks for each participant and consists of a pre-screening phase of up to 30 days, a 24-week treatment phase, and a safety follow-up appointment that takes place 16 weeks after the last dose of Rocatinlimab at week 20. If participants continue treatment with Rocatinlimab throughout the study, they may then participate in a long-term maintenance study where they can continue to be treated with Rocatinlimab.

(BASEC)

Untersuchte Krankheit(en)

Atopic dermatitis is a chronic skin condition that leads to itching and redness. Researchers want to find out if Rocatinlimab is safe and can help adults with moderate to severe AD whose symptoms do not improve or resolve with topical (i.e., applied directly to the skin) medication alone, or if it is a treatment for adults who cannot receive topical medications due to sensitive skin/allergic reactions. In this study, Rocatinlimab, an immunoglobulin-based therapy, is used in combination with topical corticosteroids (TCS/TCI). It is compared to a placebo.

(BASEC)

Sponsor

AMGEN Inc

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Ostschweiz EKOS

(BASEC)

Datum der Bewilligung durch die Ethikkommission

15.05.2023

(BASEC)

Ergebnisse der Studie