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

Kriterien zur Teilnahme
Patients can only be included in the study if all of the following criteria are met: • Patients have provided informed consent prior to the start of any study-specific activities/measures; or the legally authorized representatives of the patients have provided informed consent if the patients are legally too young to provide their own informed consent; and patients have provided their written consent prior to the start of any study-specific activities/measures in accordance with local regulations and/or guidelines. Attend an appointment at the end of treatment (week 24 for studies with adults or week 52 for studies with adolescents) in a parent Rocatinlimab study (20210142, 20210143, 20210144, 20210145, 20210158 or 20210263) within the last 14 days. (BASEC)

Ausschlusskriterien
Patients will be excluded from the study if any of the following criteria apply: Other conditions • Recently occurring suicidality or suicidal thoughts, as evidenced by agreement to items 4 or 5 of the eC-SSRS (Columbia-Suicide Severity Rating Scale) assessment conducted at screening or on day 1. • Severe depression, as assessed by the investigator during the screening phase or on day 1. Previous/current clinical trial experience • Permanent discontinuation of the investigational product for safety-related reasons, according to the stopping rules defined in the study protocol or conditions/reasons not related to efficacy, during the parent Rocatinlimab study (20210142, 20210143, 20210144, 20210145, 20210158 or 20210263) or during the screening phase or on day 1. • Participation or planned participation in a non-Rocatinlimab study protocol or a study protocol with another investigational product. Pregnant and breastfeeding women are excluded from study participation. Endpoints of the study Primary: Description of the long-term safety and tolerability of Rocatinlimab in patients with moderate to severe AD Secondary: Description of the maintenance of treatment response of the individual Rocatinlimab treatment groups compared to placebo in responders who have responded to Rocatinlimab in monotherapy studies in adults. (BASEC)