A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Phase 3 – large-scale trial before approval
Conditions:
Atopic Dermatitis
Sponsor: Amgen
trial.available_in:
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Overview
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
Who can participate
Inclusion Criteria:
* 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.
* Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
Exclusion Criteria:
* 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.
Locations
38
Argentina (1)
Conexa Investigacion Clinica SA
CABA , Buenos Aires
Australia (1)
Premier Specialists
Kogarah , New South Wales
Belgium (1)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels
Brazil (1)
Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
Vitória , Espírito Santo
Bulgaria (1)
Medical Center Asklepii OOD
Dupnitsa
Canada (1)
Dermatology Research Institute Incorporated
Calgary , Alberta
Chile (1)
Hospital Base San Jose de Osorno
Osorno
China (1)
Peking University Peoples Hospital
Beijing , Beijing Municipality
Croatia (1)
Special Hospital for Medical Rehabilitation Naftalan
Ivanić-Grad
Czech Republic (1)
Kozni ambulance Kutna Hora sro
Kutná Hora
Denmark (1)
Gentofte Hospital
Hellerup
Estonia (1)
North Estonia Medical Centre
Tallinn
Finland (1)
Clinical Research Services Helsinki
Helsinki
France (1)
Hopital Prive d Antony
Antony
Greece (1)
University General Hospital Attikon
Athens
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Hungary (1)
Trial Pharma Kft
Békéscsaba
Israel (1)
Sheba Medical Center
Ramat Gan
Italy (1)
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
Chieti
Japan (1)
Aichi Medical University Hospital
Nagakute-shi , Aichi-ken
Latvia (1)
Outpatient clinic Veselibas Centrs 4
Riga
Malaysia (1)
Hospital Sultan Ismail
Johor Bahru , Johor
Mexico (1)
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia , Michoacán
Netherlands (1)
Bravis Ziekenhuis
Bergen op Zoom
Poland (1)
ClinicMed Daniluk Nowak Spolka komandytowa
Bialystok
Puerto Rico (1)
Gcm Medical Group, Psc
San Juan
Romania (1)
Derma Cluj
Cluj-Napoca
Singapore (1)
National University Hospital
Singapore
Slovakia (1)
Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
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